A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The Section of Plastic Surgery is seeking a detail-oriented Clinical Research Coordinator to manage a specialized clinical trial working with individuals with above-elbow amputations. The study focuses on advanced prosthetic technologies for improving prosthetic performance. This position will be responsible for ensuring that all study procedures adhere to established protocols and are thoroughly documented, providing end to end regulatory and operational leadership for complex IDE regulated clinical trials to ensure compliance, data integrity, and safe study execution.

• Protocol & Regulatory Expertise
  • 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.
• Regulatory Compliance & Reporting
  • 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.
• Study Execution
  • 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.
• Participant & Clinical Coordination
  • 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.
• Other
  • 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.

• 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 3 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRAs 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 

• 6+ 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.

This position is 40 hours/week, Monday-Friday. We strongly encourage in-person work (on the medical campus) until training is complete. After that time, work from home is possible for days without study-related events. 

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

This is a 12-month term-limited position with the possibility of renewal based upon availability of work, funding, and performance. At the end of the stated term, your appointment will terminate and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not constitute a contract or guarantee of continued employment. Your position remains subject to the University's policies and standards regarding employee performance and conduct, including the possibility of disciplinary action or termination, in accordance with applicable guidelines.

Supervision Received: This position reports directly to the faculty principal investigator, Dr. Paul Cederna.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.