Michigan Medicine · 4 hours ago
Clinical Research Coordinator Assoc / Tech / Asst
Ann Arbor, MI
Full-time
Onsite
Entry, Mid Level
1+ years expMichigan Medicine is one of the largest health care complexes in the world, and they are seeking a Clinical Research Coordinator to provide study coordination for multiple clinical research studies. The role involves independent decision-making, managing patient data, and ensuring compliance with regulatory requirements.
EducationHealth CareMedical
Responsibilities
Independent 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 2 years of directly related experience in clinical research and clinical trials is necessary
Associate's degree in Health Science or an equivalent combination of related education and experience is necessary
Minimum 1 year of directly related experience in clinical research and clinical trials is necessary
High school diploma or GED is necessary
Preferred
4+ years of direct related experience
Benefits
Excellent medical, dental and vision coverage effective on your very first day
2:1 Match on retirement savings
Company
Michigan Medicine
Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Ascani
Director, Business Operations - Applied Systems Biology Core
Jack Kufahl
Chief Information Security Officer
Recent News
2025-12-11
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