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.

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.

We are seeking a highly motivated and organized Clinical Research Coordinator Senior to support the federally funded projects grant in the department of obstetrics and gynecology. The studies are a collaboration among multiple institutions:
Some of the aims of these studies include: eliminating disparities in the fibroid experience through academic and community partnership, invitro fertilization study to understand the best timing of embryo transfer, and other reproductive endocrinology and related areas of research.

The successful candidate will coordinate and streamline study operations, move the study operations forward incrementally, ensure efficient project execution, and assist with the management of clinical research activities. Working closely with principal investigators, community members, and research staff, including the communications director, community engagement manager, and Sr. CRCs. This role will coordinate multiple studies and may provide functional supervision for 1-2 junior team members.

The ideal applicant is proactive, an effective problem-solver, and excels at independent work, communication, and collaboration. Experience and foresight in anticipating project needs and recommending solutions is essential.

We value diverse perspectives and are committed to fostering a collaborative environment where every team member can thrive and contribute to our collective success.

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

Clinical Research Coordination

• Collaborate closely with the PIs, Director of Operations & Director of Communications; program manager, and study team in planning and executing study activities.
• Organize and facilitate recurring federally funded NIH & /OR PCORI study meetings (e.g., MPI, Steering Committee, Project PI). Ensure agendas are ready and minutes and next steps are distributed and documented.
• Collaborate with the onWHARD team and supervisors on logistics for the annual national study meetings and/or Open House events.
• Serve as a key administrative contact for daily study operations, tabling events, recruitment plans, maintaining communication with team members and collaborators, internal and external stakeholders, etc.
• Participate in study start-up, active, and closeout phases; maintain inventory and coordinate related tasks as directed.
• Lead study recruitment in the community and/or clinics as appropriate.

Research Data Coordination

• Support creation and upkeep of study databases. Develop survey instruments and CRFs in REDCap and/or support staff working on REDCap.
• Ensure accurate data entry and documentation through established processes and quality checks.
• Oversee scheduling of qualitative interviews, support survey development, REDCap build, and assist with qualitative analysis using NVIVO.
• Train and support staff on data management; help resolve data discrepancies.

Regulatory Coordination

• Prepare and submit IRB applications, amendments, and continuing reviews.
• Maintain regulatory documentation in compliance with guidelines, collaborating with study leadership.
• Monitor adherence to study protocols; elevate issues…