Clinical Research Study Coordinator

University of Utah; Salt Lake City (UT); On-site; USD 45,000 - 70,000; Full time

Job summary

University of Utah seeks a Clinical Research Assistant to coordinate technical and administrative details of clinical or research studies, assisting the Principal Investigator in achieving study integrity through protocol implementation.

Responsibilities include evaluating protocols for safety and clarity, attending meetings, obtaining consent and demographics, coordinating visits, documenting data, and reporting adverse events while ensuring regulatory compliance with IRB and FDA guidelines.

Qualifications

• Bachelor’s degree in a related field; equivalency allowed; IRB CITI course within 6 months.
• Demonstrated human relations and effective communication skills.
• IATA DGR training within six months may be required in some departments.

Responsibilities

• Assesses protocol for clarity and subject safety; reviews inclusion/exclusion criteria with PI and sponsor.
• Attends and participates in Investigator and staff meetings; advises team on assignments and timelines.
• Obtains informed consent, medical history and demographics; documents in source file and maintains with data.
• 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 protocol deviations and reconciles test article accountability at study close; prepares sponsor summary.
• Completes, audits, corrects CRFs and relays to sponsor.
• Assists with negotiating contract budgets and payment terms.
• Maintains documents as required by FDA guidelines.
• May contact IRB and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• Performs responsibilities as Clinical Research Assistant as needed.

Skills

Communication skills

Human relations

Team coordination

Patient safety awareness

Education

Bachelor's degree in a related field

IRB CITI Certification

IATA DGR training (within six months)

Job description

University of Utah seeks a Clinical Research Assistant to coordinate technical and administrative details of clinical or research studies, assisting the Principal Investigator in achieving study integrity through protocol implementation.

Responsibilities include evaluating protocols for safety and clarity, attending meetings, obtaining consent and demographics, coordinating visits, documenting data, and reporting adverse events while ensuring regulatory compliance with IRB and FDA guidelines.