Clinical Research Coordinators (Non-R.N.)

Job Summary

The Division of Cardiology has an immediate opening for a Clinical Research Coordinator, in the Department of Pediatrics at the University of Utah Spencer F. Eccles School of Medicine. This position will 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 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. Works under the direction of the Primary Investigator (PI).

Department Summary

The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care.

Responsibilities

Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations.

1. Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
2. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
3. 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.
4. Determines length of visits and coordinates related facility and equipment availability.
5. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
6. Completes, audits, corrects CRFs, relays CRFs to sponsor.
7. Maintains documents as required by FDA guidelines.
8. May maintain contact with IRB and prepare and submit IRB documents.
9. May ensure proper collection, processing and shipment of specimens.
10. May perform functions required of the Clinical Research Assistant as necessary.
11. Performs other related duties as assigned.