University of Michigan · 8 hours ago
Clinical Research Coord Senior
Ann Arbor, MI
Full-time
Hybrid
Senior Level
5+ years expThe University of Michigan is seeking a highly organized and proactive Clinical Research Coordinator Senior to support multiple federally-funded research projects in women's reproductive health. This role involves leading study coordination, ensuring regulatory compliance, and mentoring junior staff while collaborating with diverse stakeholders.
E-LearningEducationHigher EducationUniversities
Responsibilities
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: 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
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 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
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
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
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
Qualification
Required
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
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
Benefits
Excellent medical, dental and vision coverage effective on your very first day
2:1 Match on retirement savings
Company
University of Michigan
The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving, and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future.
10001+ employees
H1B Sponsorship
University of Michigan has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (662)
2024 (594)
2023 (787)
2022 (473)
2021 (411)
2020 (324)
Funding
Current Stage
Late StageTotal Funding
$359.75MKey Investors
Michigan Economic Development CorporationNational Institutes of HealthBreakthrough T1D
2025-07-17Grant· $1M
2025-06-07Grant· $1.17M
2025-04-23Grant
Leadership Team
Greg McGuire
Managing Director, Mcity
Robert Goodspeed
Chair, Urban and Regional Planning Program
Recent News
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