Michigan Medicine ยท 2 days ago
Clinical Research Coord Assoc
Ann Arbor, MI
Full-time
Hybrid
Entry, Mid Level
2+ years expMichigan Medicine is a leading health care complex dedicated to improving health through education, patient care, research, and technology development. The Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit will provide administrative support and coordinate clinical research studies, ensuring compliance with regulations and maintaining essential documents.
EducationHealth CareMedical
Responsibilities
Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
Explains proper documentation techniques as outlined in the ICH-GCP guidelines
Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them
Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT
Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies
Collaborates with MIAP for INDs and IDEs
Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments
Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines
Maintenance of updated regulatory documentation
Explain the investigational products development process and identify key regulations to control these processes
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)
Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying
Associate degree in Health Science or an equivalent combination of related education and experience
ONE of the following: Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying. An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research
High School Diploma or GED
Preferred
4+ years of direct related experience
Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable
Associate Degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable
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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