Michigan Medicine · 6 hours ago
Clinical Research Associate/Technician
Ann Arbor, MI
Full-time
Onsite
Entry, Mid Level
1+ years expMichigan Medicine is one of the largest health care complexes in the world, renowned for its expertise in pediatric hematology and oncology. The Clinical Research Associate/Technician will provide administrative study coordination and data entry support for clinical research studies, ensuring compliance with regulations and facilitating communication among research teams.
EducationHealth CareMedical
Responsibilities
Assist study teams with all aspects of clinical trial coordination including identifying potential subjects, screening subjects, consenting (minimal risk) and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
Coordinate and facilitate correct timing of study visits and procedures with patients and clinic staff
Coordinate the collection and integrity of research specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)
Monitor and report abnormal or unexpected findings
Create source documents for accurate tracking, collection, and recording of experimental data
Utilize critical thinking skills to recognize and solve patient/participant problems including billing issues
Work collaboratively with nurses, research pharmacy, physicians, NPs/PAs, phlebotomists and other clinical, research and administrative staff to correct/prevent protocol errors
Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate
Possibly attend investigator and scientific meetings
Serve as a resource and contact person for active protocols
Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
Integrate the workflow of many studies running simultaneously
Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintain knowledge of current ICH and CFR guidelines
Assist in the completion of regulatory duties including new study activation and processing of amendments and continuing reviews
Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
In coordination with the CTSU staff, communicate with sponsors concerning progress of clinical research, 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
Qualification
Required
Bachelor's Degree or higher preferably in health science or health related field or an equivalent combination of related education and experience
At least two years of experience coordinating Clinical Trials
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail
Excellent computer skills including proficiency in Microsoft software applications
Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines
Willingness to be flexible in a dynamic working environment
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner
Good attendance record
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 and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire
Minimum 2 years of directly related experience in clinical research and clinical trials
Associate degree or an equivalent combination of related education and experience
Minimum 1 year of directly related experience in clinical research and clinical trials
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 is necessary
Preferred
4+ years of direct related experience
Masters Degree
Reasonable understanding of clinical research
Understanding of medical terminology related to oncology
Some IRB/regulatory experience
Previous experience with Epic, MiChart, eResearch, OnCore, RedCap
Certification or planned certification through ACRP or SOCRA
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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