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Clinical Research Coord Senior

How to Apply

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.

Job Summary

The Department of Obstetrics and Gynecology seeks a highly organized, proactive, and collaborative Clinical Research Coordinator?Senior to support multiple federally-funded research projects, primarily within the onWHARD (Women?s Health and Reproductive Disparities) group. The role advances research focused on addressing disparities in women?s reproductive health (including ?broids, fertility, and related issues), facilitating incremental progress and successful execution of study operations. You will lead and streamline study coordination, provide mentorship to junior staff, ensure regulatory compliance, and work closely with diverse collaborators?faculty, sponsors, participants, and community partners.

We value diverse perspectives and foster an environment where every team member grows and contributes to lasting impact in women's health research.

Mission Statement

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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

+ Excellent medical, dental and vision coverage effective on your very first day

+ 2:1 Match on retirement savings

Responsibilities*

Contribute to the development of process and tools 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

Study Operations & Coordination

+ Lead drafting of the protocol, consent, and other required documents based on the instructions and directions provided by the PIs; lead recruitment, enrollment, consent process, and retention strategies for study participants.

+ Ensure scheduling and coordination of study visits/activities, both in clinics and community settings, communicating with clinical teams and external partners.

+ Serve as main liaison among study participants, investigators, sponsors, and operations teams.

+ Develop randomization procedure logistics and ensure adherence; draft study materials: ?yers, consent forms, SOPs, and site protocols.

+ Organize and facilitate study meetings (Steering Committees, PI groups); prepare agendas, document minutes, and track next steps.

+ Support outreach and periodic Community Advisory Board/Co-I meetings.

+ Oversee study inventory, ordering supplies, and reconcile purchases.

Data Coordination & Quality Assurance

+ Design, build, and distribute behavioral and clinical surveys; oversee qualitative data collection and coding, including support for NVIVO and REDCap.

+ Ensure robust data management and compliance with study protocols, performing regular quality checks.

+ Oversee scheduling of qualitative interviews and support data analysis.

+ Track enrollment and study progress, reporting on milestones.

Regulatory Coordination & Compliance

+ Independently prepare and manage IRB applications, amendments, continuing reviews, and other regulatory documentation. Support reliance agreements and communications between enrolling sites.

+ Maintain regulatory ?les, monitor compliance with Good Clinical Practice, ICH

+ guidelines, and university/NIH/PCORI requirements.

+ Address and escalate compliance issues promptly; coordinate responses to sponsor queries or monitor audits.

+ Guide staff in proper use of survey and study instruments.

Research Administration & Functional Supervision

+ Coordinate and streamline communication among research teams, sponsors, and stakeholders, ensuring tasks and milestones are tracked efficiently, including with outside labs (e.g. LabCorp as needed) to ensure appropriate requisition forms are available and accurate collection and dispatch of samples for resulting.

+ Manage logistical support for boards/committees, prepare presentations and reports.

+ Oversee research billing, ?nancial documentation, and protocol updates.

+ Provide functional supervision and mentorship to clinical subject coordinators, research assistants, and other team members.

+ Train new research staff on study protocols, regulatory processes, recruitment, and data management.

+ Collaborate with programming teams for NIH/PCORI app development, ensuring research integrity.

+ Assist Director of Operations with regular performance evaluations of junior research staff.

Participant Coordination & Recruitment

+ Lead recruitment and retention strategies at community events, clinics, and through digital platforms.

+ Build and maintain rapport with study participants via phone, in-person, and digital (Zoom, EHR, social media) methods.

+ Adapt outreach approaches utilizing MyChart, DataDirect, social media, and

+ collaborate with external survey research ?rms for distribution.

Outreach, Community Engagement, & Other Duties

+ Coordinate outreach to clinics/organizations and facilitate educational and

+ engagement events to inform community about research ?ndings.

+ Travel regularly across Michigan to support study sites and national meetings as necessary.

+ Support manuscript preparation, compliance reporting, documentation for NIH requirements.

+ Reconcile expenses and coordinate with vendors following university policies.

+ Support pilot grant application management and award processes.

+ Mentor new research staff and students, orienting them to study protocols.

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 exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)

+ Minimum 5 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.)

Desired Qualifications*

+ Master's, PhD, or advanced degree in a relevant discipline.

+ Previous experience training and mentoring staff.

+ Prior grant management or Financial documentation experience.

+ Supervisory experience in a research setting.

+ Bilingual fluency in Spanish and English

Work Locations

University Hospital South (UHS) Building, Ann Arbor, MI

At least 2 or 3 days per week onsite work in Ann Arbor required; hybrid remote and Field- based work is expected. Some national travel for meetings/conferences is required.

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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .

Additional Information

This position is term limited with an expected end date of January 31, 2027. There is a possibility of an extension dependent on funding.

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 Detail

Job Opening ID

272560

Working Title

Clinical Research Coord Senior

Job Title

Clinical Research Coord Senior

Work Location

Ann Arbor Campus

Ann Arbor, MI

Modes of Work

Hybrid

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Medical School

Department

MM Obstetrics & Gynecology Dpt

Posting Begin/End Date

1/12/2026 - 2/02/2026

Career Interest

Research