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, 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.

Minimum Qualifications

Equivalency Statement: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience).

The department may hire an employee at one of the following job levels:

• Clinical Study Coordinator III: Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. This is a Career-Level position in the General Professional track. Job Code: P51733, Grade: P12.

Preferences

• Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience.
• Assumes work equivalency (1 year of higher education can be substituted for 1 year of directly related work experience).

Additional Information

This position is a benefited staff role. The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.

The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

Pay

Pay Rate Range: $55,000 – $57,976. Expected Pay Range for Clinical Study Coordinator III: $27,194 to $62,386.

Schedule

This is a full-time, benefited staff position. Standard hours per week: 40. Shift: Day. Work Schedule Summary: M–F.

This response is AI-generated, for reference only.