Essential Functions
1. Consent patients in the clinical environment for research studies, perform study phlebotomy and administer study related surveys.
2. Work with the research team to process blood and tissue specimens for the study’s biorepository.
3. Enter clinical data into REDCAP and Open Specimen databases. Summarize REDCAP data and prepare regular recruitment reports
4. Communicate with study patients to schedule and send reminders for research appointments
5. Prepare and distribute marketing materials to help recruit and retain patients for research studies
6. Assess protocol for clarity and subject safety, review inclusion/exclusion criteria; clarify concerns and questions with Principal Investigator and sponsor.
7. Attend and participate in Investigator and staff meetings. Advise team regarding specific study assignments and timelines.
8. Coordinate and attend meetings with research collaborators
9. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor.
10. Document all protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor.
11. Complete, audit, correct CRFs, relay CRF to sponsor.
12. Monitor study related charges and direct patient reimbursements
13. Maintain documents as required by IRB and NIH guidelines.
14. Maintain contact with IRB and prepare and submit IRB documents and updates.
15. Ensure proper collection, processing and shipment of specimens.
16. Perform functions required of the Clinical Research Assistant as necessary.
Problem Solving
The study coordinator is responsible for coordinating the daily operations of the research team, coordinating the orderly and safe flow of the research project, and maintaining adequate resources for the PI to accomplish their research objectives.
Work Environment and Level of Frequency that may be required
Nearly Continuously: Clinic, office, wet laboratory, and operating room
Physical Requirements and Level of Frequency that may be required
As this is a patient facing research position the study coordinator will be responsible for patient facing work and activities and occasional specimen collection form the operating room on a daily basis. The study coordinator will be based in the University of Utah’s Sugarhouse Comprehensive Weight Management Clinic but will occasionally need to travel to University of Utah Hospital and the Huntsman Cancer Center.
