University of Michigan · 2 days ago
Clinical Research Coord Assoc
Ann Arbor, MI
Full-time
Hybrid
Entry, Mid Level
2+ years expThe University of Michigan is a leading healthcare institution dedicated to improving health outcomes through research and patient care. They are seeking a Clinical Research Coordinator Associate to provide administrative study coordination and data entry support within the Oncology Clinical Trial Support Unit, contributing to the management of clinical research studies.
E-LearningEducationHigher EducationUniversities
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
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)
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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
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