Job Description
Job Summary
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.
Responsibilities*
Expert level knowledge, skills, and abilities within all 8 competency domains is expected:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
Position specific responsibilities include:
- Maintain database of subjects with research-related data
- Manage regulatory requirements and work with IRB, CTSUs, research support units, and other research-related units in the Cancer Center, Medical School, and University regarding biorepository, clinical research, and clinical trials. This includes maintainance of all regulatory requirements in collaboration with supervisor.
- Collect, process, store, organize, and share biospecimens per SOPs and best practices
- Work with CTSUs on interventional trials and other clinical research aligned with biospecimen-specific research
- Support goals and initiatives of the Rogel and Blondy Center for Pancreatic Cancer and Rogel Cancer Center
Required Qualifications*
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the training course and/or exam at date of hire and the certification must be completed or passed etc. within 6 months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
- Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
- Experience in managing and maintain administrative data and database.
Desired Qualifications*
- 6+ years of direct related experience
Work Schedule
This will be a M-F 8-5 position with occasionally needing to stay a little later (based on OR scheduling) but also allows for flexibility in coming in later those days. Estimating less than 10% of the days worked (1-2 days/month at most).
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Additional Information
Supervision Received: This position reports directly to Associate Director for Clinical Research at Rogel and Blondy Center for Pancreatic Cancer.
Supervision Exercised: Provide Functional supervision (in limited capacity such as training) of staff as it relates to biospecimen collection and processing.
Background Screening
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.
Job Summary
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.
Responsibilities*
Expert level knowledge, skills, and abilities within all 8 competency domains is expected:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
Position specific responsibilities include:
- Maintain database of subjects with research-related data
- Manage regulatory requirements and work with IRB, CTSUs, research support units, and other research-related units in the Cancer Center, Medical School, and University regarding biorepository, clinical research, and clinical trials. This includes maintainance of all regulatory requirements in collaboration with supervisor.
- Collect, process, store, organize, and share biospecimens per SOPs and best practices
- Work with CTSUs on interventional trials and other clinical research aligned with biospecimen-specific research
- Support goals and initiatives of the Rogel and Blondy Center for Pancreatic Cancer and Rogel Cancer Center
Required Qualifications*
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the training course and/or exam at date of hire and the certification must be completed or passed etc. within 6 months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
- Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
- Experience in managing and maintain administrative data and database.
Desired Qualifications*
- 6+ years of direct related experience
Work Schedule
This will be a M-F 8-5 position with occasionally needing to stay a little later (based on OR scheduling) but also allows for flexibility in coming in later those days. Estimating less than 10% of the days worked (1-2 days/month at most).
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Additional Information
Supervision Received: This position reports directly to Associate Director for Clinical Research at Rogel and Blondy Center for Pancreatic Cancer.
Supervision Exercised: Provide Functional supervision (in limited capacity such as training) of staff as it relates to biospecimen collection and processing.
Background Screening
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.
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More about Working at U-M
- Our commitment to campus culture
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- Our commitment to employee engagement
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