University of Michigan · 23 hours ago
Clinical Research Coordinator Intermediate
Ann Arbor, MI
Full-time
Onsite
Mid, Senior Level
3+ years expThe University of Michigan is dedicated to improving health through education, patient care, community service, research, and technology development. They are seeking a Clinical Research Coordinator Intermediate to provide study coordination for multiple clinical research studies, demonstrating advanced skills in managing clinical trials and ensuring compliance with regulatory requirements.
E-LearningEducationHigher EducationUniversities
Responsibilities
Expert level knowledge, skills, and abilities 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
Assist study team with aspects of clinical research coordination including identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.)
Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports
In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits
Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
Prepare and organize space for study related materials and equipment
The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus
Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality
This person may help mentor and train other CRC staff through formal and informal presentations
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 3 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
6+ years of direct related experience
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
2025-12-19
IEEE Spectrum
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