"Clinical Research Coord Senior"

Posted: 15-Jan-26

Location: Ann Arbor, Michigan

Categories: Staff/Administrative

Internal Number: 272560

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.

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 fibroids, 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.

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: flyers, 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 files, 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, financial 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 firms for distribution.

Outreach, Community Engagement, & Other Duties

• Coordinate outreach to clinics/organizations and facilitate educational and engagement events to inform community about research findings.
• 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.)

Preferred 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

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