Job Description
Job Summary
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
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 maintenance 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 2 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 maintaining administrative data and databases.
Desired Qualifications*
- 4+ 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 depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
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 maintenance 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 2 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 maintaining administrative data and databases.
Desired Qualifications*
- 4+ 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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