Clinical Study Coordinator

Job Summary

Coordinate technical and administrative details of clinical trials or research studies, assisting Principal Investigators in implementing and completing study protocols and procedures. Assess protocol clarity and subject safety, review inclusion/exclusion criteria, and address concerns with the PI and sponsor. Participate in meetings, advising on assignments and timelines. Obtain informed consent, medical history, and demographics, and maintain accurate documentation. Coordinate facility and equipment availability for study visits. Report adverse events, including serious AEs, to the IRB and sponsor. Document protocol deviations, reconcile test article accountability, and prepare summary reports. Complete, audit, correct, and relay CRFs to the sponsor. Assist with negotiating contract budgets and terms, maintain documents per FDA guidelines, manage IRB documents, and ensure proper specimen collection, processing, and shipment. Perform Clinical Research Assistant functions as needed.

Responsibilities

• Coordinate technical and administrative details of clinical trials or research studies.
• Assist Principal Investigators in implementing and completing study protocols and procedures.
• Assess protocol clarity and subject safety; review inclusion/exclusion criteria and address concerns with the PI and sponsor.
• Participate in meetings, advising on assignments and timelines.
• Obtain informed consent, medical history, and demographics; maintain accurate documentation.
• Coordinate facility and equipment availability for study visits.
• Report adverse events, including serious AEs, to the IRB and sponsor.
• Document protocol deviations, reconcile test article accountability, and prepare summary reports.
• Complete, audit, correct, and relay case report forms (CRFs) to the sponsor.
• Assist with negotiating contract budgets and terms; maintain documents per FDA guidelines.
• Manage IRB documents and ensure proper specimen collection, processing, and shipment.
• Perform Clinical Research Assistant functions as needed.

Minimum Qualifications

Requires a bachelor's degree (or equivalency) plus 6 years of directly related work experience, or a master's degree (or equivalency) plus 4 years of directly related work experience. One year of higher education may be substituted for one year of directly related work experience.

Job Code: P51733 | Grade: P12 | Department: 00269 – Orthopedic Surgery | Location: Campus (University of Utah)

Pay

Expected Pay Range: $27,194 to $62,386.

Pay Rate Range for this position: $55,000 – $57,976.

Schedule

Full‑time position. Work schedule: Monday through Friday.