Job Description

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Technician position is required.

The Research Study Coordinator will play a crucial role in supporting clinical studies by facilitating patient recruitment, enrollment, and retention. This role includes direct patient engagement, data management, and administrative responsibilities to ensure compliance with study protocols and institutional guidelines. This position requires full-time, in-person engagement and reports to three Principal Investigators (PIs) in a collaborative leadership structure.

This role offers an excellent opportunity for growth within the clinical research field, providing hands-on experience with patient care, data management, and regulatory compliance in clinical research. The in-person requirement facilitates direct interaction with patients and research staff, essential for optimal study execution.

Experience as part of a team with 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

Essential Functions & Job Duties:

• Patient Recruitment and Enrollment 
• Actively recruit potential participants for clinical studies through direct outreach, patient database searches, and by liaising with clinical teams.
• Coordinate pre-screening, eligibility assessment, informed consent, and enrollment of study participants.
• Provide participants with information regarding study protocols, ensuring that they fully understand the requirements, risks, and benefits of the study.

Longitudinal Patient Follow-up: 

• Maintain regular contact with study participants throughout the study to monitor adherence, schedule follow-up visits, and manage any concerns.
• Conduct in-person or phone follow-up visits as specified in the study protocol, documenting any changes in participant health status, adverse events, or compliance issues.

Data Entry and Management: 

• Accurately enter patient data into REDCap or other study databases in real time, ensuring data integrity and completeness.
• Conduct quality control checks and resolve any discrepancies in data entries.
• Generate and submit data reports as required by study protocols and PI requests.

Regulatory and Compliance Management:

• Prepare and submit initial IRB applications, renewals, amendments, and any protocol deviation reports in a timely manner.
• Monitor regulatory timelines and ensure that all study documentation complies with institutional and federal regulations.
• Coordinate with the IRB, data safety monitoring board, and other regulatory bodies as needed.

Administrative and Study Coordination Support: 

• Schedule and coordinate study-related meetings, including with the PI team, clinical staff, and other research personnel.
• Assist with the development and implementation of study protocols, case report forms, and other research materials.
• Support grant and study budget management activities as needed.

Supervision Received: This position reports directly to three Principal Investigators, Dr. Bishu, Dr. Singh, and Dr. Lee, who collectively oversee the research projects. The coordinator will receive specific project assignments and oversight from each PI depending on the study?s needs. The PIs will meet regularly with the coordinator to provide feedback, set objectives, and address any study or protocol issues.

Supervision Exercised: none

Technician Level:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary. 
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs  Definition of a Clinical Research Professional for qualifying experience prior to applying.) or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research. 

Assistant Level: 

• High school diploma or GED is necessary.

An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. 

Technician Level:

• Bachelor?s degree in Health Science or an equivalent combination of related education and experience is desirable. 

Assistant Level: 

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.

This is a full time in person position. 

This position may be underfilled at the CRC-Assistant title based on selected candidates’ qualifications.

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. 

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.

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

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.

The University of Michigan is an equal opportunity/affirmative action employer.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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