Clinical Research Coord Senior

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 ?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.

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.

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 30,000employees 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.

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Contribute to the development of process and tools within all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

• 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.

• 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.

• 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 escalte compliance issues promptly; coordinate responses to sponsor queries or monitor audits.
• Guide staff in proper use of survey and study instruments.

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