Senior Clinical Research Associate-Southeast Region (REMOTE)
Job DescriptionWe care deeply about helping the world be well.
We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease.
Clinical trials are an essential part of this process.
The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
Core tasks, including but not limited to, the following:
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, 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 the 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 Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager, and Clinical Project Manager.
Manages and maintains information and documentation in the Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.
Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, buddy/mentor, and sharing best practices as appropriate/required.
Supports and/or leads audit/inspection activities as needed.
Mentor/train other Clinical Research Associate team members Education and Experience B.
A.
/B.
S degree required; strong emphasis in science and/or biology preferred.
Minimum of 4 years of direct site management (monitoring) experience in a Bio/Pharma.
/ Clinical Research Organization.
Travel Expectations Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected traveling 2-3 days/week.
The current driver's license required.
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 International Conference on Harmonization Good Clinical Practice (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 the 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.
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.
Works with high quality and compliance mindset Demonstrates commitment to Customer focus.
EligibleforERPNOTICE FOR INTERNAL APPLICANTSIn 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.
Residents of ColoradoClick here to request this role's pay range.
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 HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents OnlyOur company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read CarefullyMerck & 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 StatusRegularRelocationNo relocationVISA SponsorshipNoTravel Requirements50%Flexible Work ArrangementsRemote WorkShiftNot IndicatedValid Driving LicenseYesHazardous Material(s):
NO Recommended Skills Adaptability Auditing Biology Clinical Research Clinical Trials Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease.
Clinical trials are an essential part of this process.
The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
Core tasks, including but not limited to, the following:
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, 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 the 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 Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager, and Clinical Project Manager.
Manages and maintains information and documentation in the Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.
Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, buddy/mentor, and sharing best practices as appropriate/required.
Supports and/or leads audit/inspection activities as needed.
Mentor/train other Clinical Research Associate team members Education and Experience B.
A.
/B.
S degree required; strong emphasis in science and/or biology preferred.
Minimum of 4 years of direct site management (monitoring) experience in a Bio/Pharma.
/ Clinical Research Organization.
Travel Expectations Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected traveling 2-3 days/week.
The current driver's license required.
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 International Conference on Harmonization Good Clinical Practice (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 the 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.
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.
Works with high quality and compliance mindset Demonstrates commitment to Customer focus.
EligibleforERPNOTICE FOR INTERNAL APPLICANTSIn 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.
Residents of ColoradoClick here to request this role's pay range.
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 HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents OnlyOur company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read CarefullyMerck & 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 StatusRegularRelocationNo relocationVISA SponsorshipNoTravel Requirements50%Flexible Work ArrangementsRemote WorkShiftNot IndicatedValid Driving LicenseYesHazardous Material(s):
NO Recommended Skills Adaptability Auditing Biology Clinical Research Clinical Trials Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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