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.
In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute's mission and this position.
Responsibilities
- 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.
- 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.
- Enters study relevant data in required databases as outlined by protocol and department SOPS.
Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.
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