PS Study Coordinator

Job Summary

Coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve - which includes Idaho, Montana, Nevada, Utah, and Wyoming - with impact worldwide.

Responsibilities

1. Assesses protocol for clarity and subject safety, reviews study 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. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
7. Completes, audits, corrects CRFs, relays CRFs to sponsor.
8. Assists with negotiating contract budget and payment terms.
9. Maintains documents as required by FDA guidelines.
10. May maintain contact with IRB and prepare and submit IRB documents.
11. May ensure proper collection, processing and shipment of specimens.
12. May perform functions required of the Clinical Research Assistant as necessary.