Clinical Research Study Coordinator

University of Utah; Salt Lake City (UT); On-site; USD 25,000 - 49,000; Full time

Job summary

University of Utah Health is seeking a Clinical Research Coordinator (Non-R.N.) to coordinate technical and administrative details involved in a clinical or research study, assisting the Principal Investigator in achieving study integrity through successful protocol implementation. This patient-sensitive role requires immunization per CDC/hospital policy and may require IATA DGR training within six months.

The Huntsman Cancer Institute serves a broad region and is committed to cancer prevention,

Qualifications

• Bachelor’s degree or equivalent with up to 2 years of related work experience.
• IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire.

Responsibilities

• Assesses protocol for clarity and subject safety, reviews study 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.
• Assists with negotiating contract budget and payment terms.
• 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.
• May perform functions required of the Clinical Research Assistant as necessary.

Education

Bachelor’s degree or equivalent

Job description

University of Utah Health is seeking a Clinical Research Coordinator (Non-R.N.) to coordinate technical and administrative details involved in a clinical or research study, assisting the Principal Investigator in achieving study integrity through successful protocol implementation. This patient-sensitive role requires immunization per CDC/hospital policy and may require IATA DGR training within six months.

The Huntsman Cancer Institute serves a broad region and is committed to cancer prevention,