Clinical Research Coordinator: Study Operations & Compliance

Details This; Campus (IL); On-site; USD 55,000 - 75,000; Full time

Job summary

University of Utah is seeking a Clinical Research Coordinator to manage and coordinate detailed clinical or research studies under the supervision of the Principal Investigator. You will ensure protocol integrity, assist with study procedures, and support regulatory compliance across study sites.

The role involves data collection, consent processes, safety monitoring, and collaboration with sponsors and the IRB. Prior IRB/CITI training and vaccination requirements are essential.

Qualifications

• Bachelor’s degree in a related field or equivalency; one year of education can be substituted for two years of related work experience.
• IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire.
• Demonstrated human relations and effective communication skills.
• Some departments may require IATA DGR training within six months.
• Must fulfill vaccination requirements or approved exemption prior to first day of work.
• Ability to perform the essential functions of the job as outlined in the position description.

Responsibilities

• Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns with PI and sponsor.
• Attends and participates in Investigator and staff meetings; advises team on assignments and timelines.
• Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data.
• Determines length of visits and coordinates related facility and equipment availability.
• Reports adverse events (AE) and reports serious AEs to IRB and sponsor.
• Documents protocol deviations and prepares summary reports for sponsor.
• Completes, audits, corrects CRFs and relays CRFs to sponsor.
• Assists with negotiating contract budget and payment terms.
• Maintains documents as required by FDA guidelines.

Skills

Communication skills

Human relations

Subject safety

Attention to detail

Education

Bachelor’s degree or equivalency

IRB CITI Course certificate

Tools

IATA DGR training

Job description

University of Utah is seeking a Clinical Research Coordinator to manage and coordinate detailed clinical or research studies under the supervision of the Principal Investigator. You will ensure protocol integrity, assist with study procedures, and support regulatory compliance across study sites.

The role involves data collection, consent processes, safety monitoring, and collaboration with sponsors and the IRB. Prior IRB/CITI training and vaccination requirements are essential.