Clinical Research Coordinator

Job Summary

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Coordinate day‑to‑day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Implement processes and organize efforts within the study team to achieve objectives, coordinating research procedures, study visits, and follow‑up care. Create and maintain tools and documentation to track study metrics, providing updates to management. Conduct pre‑study, site qualification, study initiation, monitoring visits, and close‑out activities.

Maintain source documents and report adverse events. Recruit, screen, enroll, and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies. Work under the direction of the Primary Investigator (PI).

• Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
• Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
• Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Determines length of visits and coordinates related facility and equipment availability.
• Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
• Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
• Completes, audits, corrects CRFs, relays CRFs to sponsor.
• Assists with negotiating contract budget and payment terms.
• Maintains documents as required by FDA guidelines.
• May maintain contact with IRB and prepare and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• May perform functions required of the Clinical Research Assistant as necessary.

Coordinate day‑to‑day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Works under the direction of the Primary Investigator (PI). Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience.

This is a Developing‑Level position in the General Professional track. Job Code: PZ6512. Grade: P13. Expected Pay Range: $29,913 to $68,625.

Coordinate day‑to‑day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. Works under the direction of the Primary Investigator (PI). 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: PZ6513. Grade: P15. Expected Pay Range: $36,196 to $83,036.

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).

Type Benefited Staff

The University of Utah values candidates who have experience working in settings with students from all backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students. Individuals from historically underrepresented groups, such as minorities, women, qualified persons…