Study Coordinator

4 weeks ago


Salt Lake, Utah, United States University of Utah Full time
Job Summary

Coordinate technical and administrative details involved in a clinical or research study in the Translational Neurotherapeutics Lab. Assist the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures.

Responsibilities
  • Assess protocol for clarity and subject safety, review inclusion/exclusion criteria; clarify concerns and questions with Principal Investigator and sponsor.
  • Attend and participate in Investigator and staff meetings.
  • Advise team regarding specific study assignments and timelines.
  • Explain and obtain informed consent, medical history and demographics; document in source file and maintain with historical data, status reports, progress notes, and subject log to help ensure subject safety.
  • Determine length of visits and coordinate related facility and equipment availability.
  • Report and track adverse events (AE). Report serious AEs to IRB and sponsor.
  • Document all protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor.
  • Complete, audit, correct CRFs, relay CRFs to sponsor.
  • Assist with negotiating contract budget and payment terms.
  • Maintain 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.
Work Environment and Level of Frequency

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.


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