Clinical Research Coordinator - Assistant (Term Limited)

About the Role

This is the entry-level position on the Michigan Medicine CRC Career Ladder. The role provides administrative and coordination support for multiple clinical research projects, including registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies. While this position may assist with study coordination, it will not independently manage clinical trials.

Responsibilities

• Performs simple and moderately complex study procedures with accuracy, including clerical duties such as mailing, filing, calling patients, and obtaining medical records.
• Triages simple subject concerns and issues appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts and may create recruitment plans and materials for IRB submission.
• Assists in and attends Site Initiation Visits (SIV), monitor visits, and audits.
• Assists with regulatory aspects of clinical trial management, including preparing study procedure kits, shippers, CRFs, and requisition forms.
• Works independently or as part of a team with exceptional organizational and computer skills in Microsoft software applications.
• Demonstrates problem-solving, conflict resolution, and multitasking skills under time constraints.
• Exercises good judgment, maintains participant confidentiality, and complies with HIPAA and U of M regulations.
• May work with the Office of Research Compliance to create and post studies in ClinicalTrials.gov and obtain CTN numbers for eResearch applications.
• Completes simple to moderately complex CRFs and resolves queries in EDC systems.
• May assist in CRF development for Investigator-Initiated trials.
• May complete new eResearch applications and maintain essential regulatory documents per ICH-GCP guidelines.
• Gathers participant approval via informed consent and prepares for internal and external audits.
• Manages increasing levels of protocol complexity or volume efficiently.
• Identifies Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and reports them appropriately.
• Provides administrative support, including scanning, filing, and preparing, processing, and shipping biospecimens.
• Communicates with study participants via mail or email and schedules research visits and follow-up appointments.
• Manages study supply inventory and tracks recruitment and retention of participants.
• Completes and activates postings (advertisements, flyers, etc.) independently.
• Works with regulatory support to maintain regulatory binders (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.).

Requirements

Knowledge of all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Qualifications

• Required:
  • High school diploma or GED.
• Desired:
  • Associate Degree in Health Science or an equivalent combination of related education and experience.
  • Understanding of medical terminology.
  • Minimum 1 year of directly related experience in clinical research and clinical trials.
  • Experience in a large, complex healthcare setting.
  • Ability to effectively communicate with staff and faculty of all levels.
  • Knowledge of university policies and procedures.
  • Previous experience with spirometry testing and/or sputum induction (on-site training available).
  • Clinical experience with respiratory patients.

Training

• Completes all training requirements of the previous level, including PEERRS, HIPAA, and CITI GCP.
• Gains appropriate training and knowledge of EMR, CTMS, EDC, and databases as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understands the disease process relevant to the program.
• Attends and participates in all training classes assigned to this level.
• Assists with training activities of staff and others.

Benefits

• Excellent medical, dental, and vision coverage effective on the first day.
• 2:1 match on retirement savings.

Schedule

• Hybrid work mode (at least 2 days onsite).
• Time varies depending on research needs (e.g., 8:00 AM - 4:30 PM, 7:00 AM - 3:30 PM, 10:00 AM - 6:30 PM).

Additional Information

This position receives direct supervision from a CRC-Project Manager and does not supervise others. Michigan Medicine is committed to advancing inclusion, diversity, equity, accessibility, and belonging. This is a term-limited appointment; at the end of the stated term, the appointment will terminate and will not be eligible for Reduction-in-Force (RIF) benefits. Background screening and pre-employment drug testing are required.