Clinical Research Study Coordinator

2 weeks ago


Salt Lake, Utah, United States University of Utah Full time
Position Overview

The Clinical Research Study Coordinator plays a vital role in managing the technical and administrative aspects of clinical or research studies. This position supports the Principal Investigator(s) in ensuring the integrity and objectives of the study are met through effective implementation and adherence to established protocols and procedures.

Key Responsibilities
  • Evaluate study protocols for clarity and participant safety, ensuring compliance with inclusion and exclusion criteria; address any concerns with the Principal Investigator and sponsor.
  • Participate in Investigator and team meetings to provide insights and updates on study progress.
  • Guide the research team on specific study tasks and timelines to ensure smooth operations.
  • Facilitate the informed consent process, gather medical histories and demographic information, and maintain accurate documentation in source files, including historical data, status reports, progress notes, and subject logs to ensure participant safety.
  • Coordinate visit lengths and manage the availability of necessary facilities and equipment.
  • Monitor and report adverse events (AEs), ensuring serious AEs are communicated to the Institutional Review Board (IRB) and sponsor.
  • Document all protocol deviations, manage test article accountability at study conclusion, and prepare summary reports for the sponsor.
  • Complete, audit, and correct Case Report Forms (CRFs), ensuring timely submission to the sponsor.
  • Assist in negotiating contract budgets and payment terms, maintaining compliance with FDA documentation requirements.

Additional Duties
  • Maintain communication with the IRB and prepare necessary documentation for submission.
  • Ensure proper collection, processing, and shipment of specimens as required.
  • Perform tasks typically assigned to a Clinical Research Assistant when necessary.

Work Environment

This role is primarily office-based, requiring nearly continuous sitting, hearing, listening, and talking. Occasional walking and repetitive hand motions (such as typing) are also expected. Bending and reaching overhead are seldom required.


Qualifications

A Bachelor's degree in a relevant field or equivalent experience is required. Candidates must complete the IRB CITI Course in the Protection of Human Research Subjects within six months of hire. Strong human relations and effective communication skills are essential.

This position involves direct interaction with patients, necessitating compliance with all associated health and safety requirements, including immunization according to CDC standards and hospital policy. Limited exemptions may be available for documented medical contraindications or religious beliefs against vaccinations.


Preferred Qualifications

Additional training such as IATA DGR may be required within six months, depending on departmental needs.



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