Statistical Assistants

**Job Description**

With support of Sr CRA (Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

**Performs remote and on-site monitoring & oversight activities using various tools to ensure:**

+ Data generated at site are complete, accurate and unbiased

+ Subjects’ right, safety and well-being are protected

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM (Clinical Research Manager), TA Head and CRD (Clinical Research Director) as needed.

+ Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Supports audit/inspection activities as needed.

+ Performs co-monitoring where appropriate.

**Extent of Travel:**

+ Ability to travel domestically and internationally approximately 65%-75% of working time.

+ Expected travelling ~2-3 days/week.

+ Current driver’s license preferred.

**Qualifications, Skills & Experience**

**Competency Expectations:**

+ Fluent in Local Languages and English (verbal and written) and excellent

+ communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices

+ Developing skills in Site Management including management of site performance and patient recruitment

+ Developing level of monitoring skill and independent professional judgment.

+ Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Works with high quality and compliance mindset.

+ Capable of managing complex issues, solution-oriented approach.

+ Ability to perform root cause analysis and implement preventative and corrective action.

**Behavioral Competency Expectations:**

+ Effective time management, organizational and interpersonal skills, conflict

+ management

+ Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

**Requirements:**

+ B.A./B.S. required with strong emphasis in science and/or biology.

+ Min. 2 years of clinical research experience. Related CR (Clinical Research) experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC (Clinical Trial Coordinator) or similar.

**MRLGCTO**

**\#EligibleforERP**

**ETJOBS**

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$75,400.00 - $118,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

05/24/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R295855

**Job Description**

With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ Data generated at site are complete, accurate and unbiased

+ Subjects’ right, safety and well-being are protected

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

+ Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Supports audit/inspection activities as needed.

+ Performs co-monitoring where appropriate.

Extent of Travel

+ Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

+ Current driver’s license preferred.

**Qualifications, Skills & Experience**

**Education Minimum Requirement:**

+ B.A./B.S. required with strong emphasis in science and/or biology.

+ Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

**Competency Expectations:**

+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

+ Spanish speaking skills preferred.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices

+ Developing skills in Site Management including management of site performance and patient recruitment

+ Developing level of monitoring skill and independent professional judgment.

+ Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Works with high quality and compliance mindset.

+ Capable of managing complex issues, solution-oriented approach.

+ Ability to perform root cause analysis and implement preventative and corrective action.

**Behavioral Competency Expectations:**

+ Effective time management, organizational and interpersonal skills, conflict management

+ Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices

**MRLGCTO**

**\#EligibleforERP**

**ETJOBS**

**NOTICE FOR INTERNAL APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$75,400.00 - $118,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

05/24/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R295713

**Job Description**

With support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ Data generated at site are complete, accurate and unbiased

+ Subjects’ right, safety and well-being are protected

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM (Clinical Research Manager, TA Head and CRD (Clinical Research Director) as needed.

+ Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Supports audit/inspection activities as needed.

+ Performs co-monitoring where appropriate.

**Extent of Travel**

+ Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

+ Current driver’s license preferred.

**Qualifications, Skills & Experience**

**Competency Expectations:**

+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices

+ Developing skills in Site Management including management of site performance and patient recruitment

+ Developing level of monitoring skill and independent professional judgment.

+ Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Works with high quality and compliance mindset.

+ Capable of managing complex issues, solution-oriented approach.

+ Ability to perform root cause analysis and implement preventative and corrective action.

**Behavioral Competency Expectations:**

+ Effective time management, organizational and interpersonal skills, conflict management

+ Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices

+ B.A./B.S. required with strong emphasis in science and/or biology.

+ Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC (Clinical Trial Coordinator) or similar.

**MRLGCTO**

**\#EligibleforERP**

**ETJOBS**

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$75,400.00 - $118,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

05/24/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R296049

**Job Description**

With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ o Data generated at site are complete, accurate and unbiased

+ o Subjects’ right, safety and well-being are protected

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

+ Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Supports audit/inspection activities as needed.

+ Performs co-monitoring where appropriate.

**Extent of Travel**

+ Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

+ Current driver’s license preferred.

**Qualifications, Skills & Experience**

**Competency Expectations:**

+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

+ Spanish speaking skills preferred.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices

+ Developing skills in Site Management including management of site performance and patient recruitment

+ Developing level of monitoring skill and independent professional judgment.

+ Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Works with high quality and compliance mindset.

+ Capable of managing complex issues, solution-oriented approach.

+ Ability to perform root cause analysis and implement preventative and corrective action.

**Behavioral Competency Expectations:**

+ Effective time management, organizational and interpersonal skills, conflict management

+ Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

**Education Minimum Requirement:**

+ B.A./B.S. required with strong emphasis in science and/or biology.

+ Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

**MRLGCTO**

**\#EligibleforERP**

**ETJOBS**

**NOTICE FOR INTERNAL APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$75,400.00 - $118,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

05/24/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R295719

**Job Description**

**Position Description:**

With support of Sr CRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ Data generated at site are complete, accurate and unbiased

+ Subjects’ right, safety and well-being are protected

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

+ Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Supports audit/inspection activities as needed.

+ Performs co-monitoring where appropriate.

**Extent of Travel**

+ Ability to travel domestically and internationally approximately 65%-75% of working time.

+ Expected travelling ~2-3 days/week.

+ Current driver’s license preferred.

**Qualifications, Skills & Experience**

Competency Expectations:

+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices

+ Developing skills in Site Management including management of site performance and patient recruitment

+ Developing level of monitoring skill and independent professional judgment.

+ Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Works with high quality and compliance mindset.

+ Capable of managing complex issues, solution-oriented approach.

+ Ability to perform root cause analysis and implement preventative and corrective action.

Behavioral Competency Expectations:

+ Effective time management, organizational and interpersonal skills, conflict management

+ Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

**Education Minimum Requirement:**

+ B.A./B.S. required with strong emphasis in science and/or biology.

+ Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

**MRLGCTO**

**\#EligibleforERP**

**ETJOBS**

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$75,400.00 - $118,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

05/24/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R295706

**Job Description**

**Position Description:**

**Associate Clinical Research Associate - Northeast Region (Remote)**

With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ o Data generated at site are complete, accurate and unbiased

+ o Subjects’ right, safety and well-being are protected

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

+ Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Supports audit/inspection activities as needed.

+ Performs co-monitoring where appropriate.

Extent of Travel

+ Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

+ Current driver’s license preferred.

**Position Qualifications:**

**Education Minimum Requirement:**

+ B.A./B.S. required with strong emphasis in science and/or biology.

+ Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

**Required Experience and Skills:**

Competency Expectations:

+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices

+ Developing skills in Site Management including management of site performance and patient recruitment

+ Developing level of monitoring skill and independent professional judgment.

+ Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Works with high quality and compliance mindset.

+ Capable of managing complex issues, solution-oriented approach.

+ Ability to perform root cause analysis and implement preventative and corrective action.

Behavioral Competency Expectations:

+ Effective time management, organizational and interpersonal skills, conflict management

+ Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices

**MRLGCTO**

**\#EligibleforERP**

**ETJOBS**

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$75,400.00 - $118,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

Na

**Job Posting End Date:**

05/24/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R295722

**Job Description**

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

**Responsibilities include, but are not limited to:**

+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected.

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

+ Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

+ Supports and/or leads audit/inspection activities as needed.

+ Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

+ Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

+ Could perform Quality control visits if delegated by other roles and trained appropriately.

**Extent of Travel**

+ Ability to travel domestically and internationally approximately 65%-75% of working time.

+ Expected travelling ~2-3 days/week.

+ Current driver’s license preferred (Must have in certain countries).

**Qualifications, Skills & Experience**

**CORE Competency Expectations:**

+ Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

+ Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

+ Demonstrated ability to mentor/lead.

+ Hands on knowledge of Good Documentation Practices.

+ Proven Skills in Site Management including independent management of site performance and patient recruitment.

+ Demonstrated high level of monitoring skill with independent professional judgment.

+ Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.

+ Experience with conducting site motivational visit designed to boost site enrollment.

+ Capable of managing complex issues, works in a solution-oriented manner.

+ Performs root cause analysis and implements preventative and corrective action.

+ Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.

**Behavioral Competency Expectations:**

+ Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.

+ Able to work highly independently across multiple protocols, sites and therapy areas.

+ High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

+ Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

+ Demonstrates commitment to Customer focus.

+ Works with high quality and compliance mind-set.

+ Positive mindset, growth mindset, capable of working independently and being self-driven.

+ Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

**Experience Requirements:**

**Required:**

+ Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.

**Educational Requirements:**

**Preferred:**

+ B.A./B.S. with strong emphasis in science and/or biology.

MRLGCTO

\#EligibleforERP

**NOTICE FOR INTERNAL APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$122,800.00 - $193,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

05/19/2024

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Job Posting End Date:** 05/19/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**Requisition ID:** R282954

Position Description:

Mathematica applies expertise at the intersection of data, methods, policy, and practice to improve well-being around the world. We collaborate closely with public- and private-sector partners to translate big questions into deep insights that improve programs, refine strategies, and enhance understanding. Our work yields actionable information to guide decisions in wide-ranging policy areas, from health, education, early childhood, and family support to nutrition, employment, disability, and international development. Mathematica offers our employees competitive salaries, and a comprehensive benefits package, as well as the advantages of being 100 percent employee owned. As an employee stock owner, you will experience financial benefits of ESOP holdings that have increased in tandem with the company’s growth and financial strength. You will also be part of an independent, employee-owned firm that is able to define and further our mission, enhance our quality and accountability, and steadily grow our financial strength. Learn more about our benefits here: https://www.mathematica.org/career-opportunities/benefits-at-a-glance

At Mathematica, we take pride in our commitment to diversity. Building an inclusive culture that draws on the individual strengths of employees from different ethnic backgrounds, cultures, lifestyles, abilities, and experience is key to our success.

We are inviting Health Research Analysts with a *quantitative focus* to join us in contributing to domestic health policy projects. Our current work includes a wide range of topics in health care service delivery and financing, quality measures, and health systems change. Health analysts work on a variety of projects spanning policy and programmatic areas as well as program evaluation and implementation support. They typically work on more than one project at a time and are matched to projects that suit their interests and skills and offer opportunities for professional growth.

*Example projects include:*

* Evaluating the implementation and impact of Medicare and Medicaid innovation initiatives aimed at expanding access to care, improving health care quality, promoting health outcomes, or reducing costs.
* Studying the effects of multi payer delivery system innovations on health care access, quality, health outcomes, and costs.
* Analyzing, designing, and producing large federal health insurance program datasets and reporting systems.
* Designing and implementing state-of-the-art methods to measure service utilization and quality of care in support of value-based payment reforms.
* Assessing the quality of health care in publicly sponsored insurance programs like Medicaid and Medicare.
* Designing efficient and effective payment models and delivery systems.
* Contributing to the development, testing, and maintenance of quality measures.
* Providing technical assistance and learning support for stakeholders, such as policymakers and health care providers.
* Working with states to address Medicaid payment reform initiatives and multi-payer proposals, improving health service delivery.
* Conducting analysis and studies on COVID-19 impacts on patient populations and provider services.

Responsibilities: Health Research Analysts with a quantitative focus will participate in key project activities, which vary by project and may include:

* Contributing to quantitative analyses using large databases to determine program outcomes or to conduct policy simulations, including:
o Developing programming specifications for data cleaning and analytic file construction.
o Summarizing data quality issues.
o Participating in quality assurance of code and output.
o Defining analysis specifications and output formats and shells.
o Developing user manuals and other documentation for reporting systems and analytic tools.
o Drafting client memos, issue briefs, chapters of analytic reports, and proposals for new projects.
o Other potential responsibilities, such as:
+ Participating in interviews or site visits to assess the implementation and cost of state, federal, and local health care programs.
+ Supporting analysis of qualitative data collected from interviews, site visits, or other data collection efforts.
+ Providing technical assistance to state and federal health agencies or health care providers (for example, by designing webinars or responding to questions from providers/stakeholders).
+ Reviewing and summarizing the literature on current health policy topics

Position Requirements:

* Master’s degree in public policy, economics, statistics, public health, social work, or a related field, or an equivalent combination of education and experience.
* Strong analytic skills, including knowledge of quantitative analytic research methods.
* Strong critical thinking, problem-solving, and time management skills.
* Excellent oral and written communication skills; ability to write clear and concise technical memos and documents and accessible stakeholder-facing memos, briefs, and presentation materials.
* Ability to complete tasks on tight deadlines without compromising quality.
* Ability to support multiple projects and balance competing priorities.
* Experience working with a state or federal government, foundation, policy research organization, or health care program is highly desirable.
* Knowledge of Medicare or Medicaid policies and programs, and/or experience working with Medicare or Medicaid eligibility and claims data is a plus.
* Candidates with post-graduate, relevant professional experience in priority policy areas, such as Medicare or Medicaid, are encouraged to apply.

To apply, please submit a cover letter, resume, writing sample from an analysis, and salary expectations at the time of your application.

This position offers an anticipated base salary of $70,000 - $95,000 annually. This position may be eligible for a discretionary bonus based on company and individual performance.

Staff in our Health unit will eventually work with our largest client, Centers for Medicaid & Medicare Services (CMS). Most staff working on CMS contracts will be required to complete a successful background investigation including the Questionnaire for Public Trust Position SF-85. Staff that are unable to successfully undergo the background investigation will need to be able to obtain work outside CMS. Staff will work with their supervisor to get re-staffed, however if they are unable to do so it may result in employment termination due to lack of work.

#remote-usa

#LI-PD1

*Available locations: Washington, DC; Princeton, NJ; Cambridge, MA; Oakland, CA; Ann Arbor, MI; Chicago, IL; Remote *

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Position Description:

Mathematica applies expertise at the intersection of data, methods, policy, and practice to improve well-being around the world. We collaborate closely with public- and private-sector partners to translate big questions into deep insights that improve programs, refine strategies, and enhance understanding. Our work yields actionable information to guide decisions in wide-ranging policy areas, from health, education, early childhood, and family support to nutrition, employment, disability and international development. Mathematica offers our employees competitive salaries and a comprehensive benefits package, as well as the advantages of being 100 percent employee owned. As an employee stock owner, you will experience financial benefits of ESOP holdings that have increased in tandem with the company’s growth and financial strength. You will also be part of an independent, employee-owned firm that is able to define and further our mission, enhance our quality and accountability, and steadily grow our financial strength. Learn more about our benefits here: https://www.mathematica.org/career-opportunities/benefits-at-a-glance

At Mathematica, we take pride in our commitment to diversity. Building an inclusive culture that draws on the individual strengths of employees from different ethnic backgrounds, cultures, lifestyles, abilities, and experience is key to our success.

We are looking for masters-level health Statistical Analysts to join our vibrant group of over 50 statisticians and data scientists. The contributions of our statisticians and statistical analysts underpin our ability to produce crucial evidence for policy and decision makers, ultimately furthering our mission to improve public well-being. For example, our statistical analysts have developed COVID-19 decision tools, extended state-of-the-art methods for identifying treatment effect heterogeneity to enhance primary care delivery, and leveraged Bayesian factorial design to improve the presentation of school choice information to low-income parents. As part of their employment, statistical analysts benefit from the mentorship of more senior statisticians and subject-matter experts, learning new techniques and familiarizing themselves with new topic areas through involvement in analyses.

*Responsibilities:*

* Analysis: Apply statistical and quantitative methods to evaluate and improve social programs and policies, with the oversight of more senior statisticians. Assist in designing rigorous studies, determining appropriate analytic methods, and interpreting findings.
* Programming: Write programs to perform all stages of quantitative analysis, including: (1) conduct data extraction, cleaning, and manipulation, (2) apply advanced statistical and quantitative techniques, and (3) develop programs to calculate descriptive statistics, populate tables, and visualize results.
* Communication: Draft sections of reports, including technical appendices, and presentations for colleagues, policymakers and other stakeholders. Communicate findings to internal project teams via memos, presentations, or markdown files.
* Business development: Assist on proposals for new research projects, especially the quantitative methods sections.

Position Requirements:

* Master’s degree in a quantitative discipline, such as statistics, biostatistics, applied mathematics, quantitative economics, or a related field, or an equivalent combination of education and experience.
* Expertise in some of the following statistical and/or quantitative methods: causal inference at both the design (matching or weighting for comparison group selection) and analysis (regression) phases, experimental design, Bayesian inference, hierarchical/multilevel modeling, longitudinal data analysis, performance measurement, SEIR modeling, spatial statistics, small area estimation, survey statistics and predictive modeling.
* Fluency in one or more of the following statistical programming languages: R (preferred), Python, Stan, Julia, Stata, or SAS
* Excellent written and oral communication skills, including an ability to translate statistical methods and findings for a non-technical audience.
* Experience using cloud computing platforms and services, such as Amazon Web Services (AWS) preferred.
* Experience contributing to written deliverables, such as proposals, technical reports, or academic manuscripts, preferred.
* Subject-matter knowledge in health policy preferred.

To apply, please submit a cover letter, resume, writing sample, code sample and salary expectations at the time of your application. In this employment application, you will be asked whether you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status). If you are unsure of how to answer this question, answer Yes or No and provide notes in the comments/notes section provided. (For example, if you are currently in a period of OPT employment authorization, please note that in the section provided.) Anyone who applies to this position and is selected for an interview will also be verbally asked about current or future sponsorship needs.

This position offers an anticipated base salary of $70,000 - $95,000 annually. This position may be eligible for a discretionary bonus based on company and individual performance.

Staff in our Health unit will eventually work with our largest client, Centers for Medicaid & Medicare Services (CMS). Most staff working on CMS contracts will be required to complete a successful background investigation including the Questionnaire for Public Trust Position SF-85. Staff that are unable to successfully undergo the background investigation will need to be able to obtain work outside CMS. Staff will work with their supervisor to get re-staffed, however if they are unable to do so it may result in employment termination due to lack of work.

#remote-usa

#LI-PD1

Available locations: Washington, DC; Princeton, NJ; Cambridge, MA; Oakland, CA; Ann Arbor, MI; Chicago, IL; Remote

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Job Title : Research Associate III

Location : Tucson, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support company projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities

• Designs a wide range of experimental protocols.

• Executes bench experiments; makes detailed and general observations and analyzes data.

• Prepares technical reports, summaries and quantitative analyses.

• Maintains complete and accurate records.

• Normally receives general directions on routine and new assignments.

• Identifies and implements improvements to work processes and laboratory environment.

• Recognized expert for area of expertise.

• Recognizes and documents activities for publication and/or patent potential.

• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for

obtaining results.

• Participates in cross functional technical teams such as a failure investigation or core team.

• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and

providing input to project planning.

• Establishes interfaces across other organizational groups.

• Trains others in areas of expertise.

• Troubleshoots problems and institutes corrective action.

• Prepares and presents experimental procedures and results in group and project teams.

• Monitors work to ensure quality, and continuously promote Quality First Time.

• Other duties as assigned by management.

Requirements

Education/Experience:

• Bachelor’s Degree in Science required

• 4 years relevant job experience required

Knowledge, Skill or Ability:

• Knows wide range of experimental techniques and skilled in their applications.

• Capable with searching scientific literature to gain general and specific information.

• Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.