Michigan Medicine · 12 hours ago
Clinical Research Coordinator Associate- Term Limited
Ann Arbor, MI
Full-time
Hybrid
Mid, Senior Level
2+ years expMichigan Medicine is seeking a detail-oriented Clinical Research Coordinator Associate to manage a specialized clinical trial focused on advanced prosthetic technologies for individuals with above-elbow amputations. This role involves ensuring compliance with established protocols, regulatory requirements, and overseeing the operational aspects of clinical trials.
EducationHealthcareHealth CareMedical
Responsibilities
Serve as the primary expert on the IDE, IRB, and clinical trial protocol for all pre implant activities and post implant medical oversight
Answer protocol-related questions and obtain authoritative guidance from MICHR, Regulatory Compliance, and FDA, as needed
Periodically audit protocol adherence, with emphasis on documentation and logs
Prepare, submit, and implement study amendments
Fulfill all regulatory and reporting requirements, including IRB, FDA/IDE, ClinicalTrials.gov, NIH/DoD, and team COI compliance
Conduct and manage all adverse event reporting, ensuring timely documentation and escalation
Audit device logs, REDCap entries, and overall regulatory documentation
Attend regulatory and compliance meetings (e.g., FDA, IRB, DSMC) with the PI
Attend key study events to ensure protocol adherence and complete documentation, including consent visits, pre/post operative visits, surgical days, first experiments, and periodic ongoing experiments
Attend clinical visits to verify accurate completion and entry of case report forms in REDCap
Maintain sufficient knowledge of study activities to draft initial reports and summaries
Order all study devices and manage accessioning, de accessioning, and labeling
Maintain clear separation between study and non study devices and equipment in accordance with protocol and FDA guidance
Ensure study personnel are appropriately trained for protocol specific tasks
Maintain a study contact list and coordinate task specific communication
Serve as the primary point of contact for study participants, including hospital based check ins
Identify and screen potential participants via databases and outreach and conduct initial participant contact
Schedule and manage all Michigan Medicine based study activities (preoperative, surgical, postoperative, and follow up visits)
Coordinate with hospital units not directly involved in the study to ensure correct scheduling and study billing
Communicate weekly with study PIs regarding progress and regulatory matters, escalating urgent issues by phone when deadlines are imminent
Organize and support DSMC operations, including arranging membership, preparing draft reports (with project support as applicable), and attending meetings
Attend weekly management meetings with the direct manager or designated investigator
Attend weekly RPNI research team meetings to monitor training, workflows, and study conduct
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. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)
Demonstrated experience supporting IRB processes, including preparing submissions, ensuring protocol compliance, and assisting with proper execution of approved research activities (clinical or nonclinical)
Excellent organizational skills
Excellent interpersonal and communication skills (verbal and written)
Knowledge of basic MS Office Suite (Word, Excel, Powerpoint) applications
Demonstrated ability to manage work across a set of diverse stakeholders (e.g., study subjects, research assistants, research investigators, regulatory staff/agencies)
Ability to set goals, exercise sound professional judgment, and problem-solve within delegated authority
Ability to work independently to meet milestones and deadlines
Excellent organizational skills and attention to detail
Ability to communicate effectively and professionally in both verbal and written forms
Solid attendance record and work ethics
Preferred
4+ years of direct related experience
Master's degree or an equivalent combination of related education and experience
Experience working with FDA clinical trials and Investigational Device Exemption (IDE) studies
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 Strategy - Michigan Kidney Translational Research Core
Jack Kufahl
Chief Information Security Officer
Recent News
2025-12-11
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