Clinical Research Coord

University of Utah; Salt Lake City (UT); On-site; USD 39,000 - 73,000; Full time

Job summary

The Division of Vascular Surgery at the University of Utah seeks a Clinical Research Coordinator to support investigator-initiated and sponsor-led studies. The role involves coordinating clinical procedures, regulatory tasks, and data management to ensure protocol integrity and safety.

Responsibilities include participant recruitment, scheduling, adverse event reporting, and assisting with IRB submissions while maintaining FDA and GCP compliance, under supervision.

Qualifications

• Bachelor's degree in health sciences or related field with two years professional research experience.
• University RATS Clinical Certification within one year of hire.
• Exceptional organizational and communication skills.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; ability to work independently.

Responsibilities

• Screen and recruit participants for clinical studies.
• Coordinate study visits and schedule facility and equipment availability.
• Maintain research documentation including CRFs and study logs.
• Report and track adverse events and notify PI and sponsor as required.
• Prepare IRB documents and ensure regulatory compliance.
• Assist with sponsor monitoring visits and budget discussions.

Skills

Clinical research coordination

IRB regulations

FDA/GCP knowledge

Organizational skills

Communication skills

Education

Bachelor's degree in health sciences or related field

Job description

Job Summary

The Division of Vascular Surgery at the University of Utah has an immediate opening for a Clinical research coordinator. This position desires a person with a strong background in clinical research. This position will: (1) assist in facilitating the conduct of clinical research by performing research duties for Vascular Surgeon Research Investigators; (2) coordinate technical and administrative details involved in both sponsor and physician-initiated clinical research studies; and (3) assist the Principal Investigator and study team in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures; and (4) coordinate clinical trials involving the investigational use of medical devices and drugs, including studies conducted under IDE and IND requirements.

Responsibilities

• Screen and recruit participants for clinical research studies.2. Fully understand the informed consent process and obtain informed consent from eligible study participants. Document the informed consent process. Write informed consent documents under the supervision of the study investigator.3. Attend and actively participate in study team meetings. Assume leadership roles within study teams.4. Schedule study visits and coordinate related facility and equipment availability.5. Assess research protocols for clarity and participant safety, review inclusion/exclusion criteria; clarify concerns and questions with Principal Investigator and sponsor.6. Collect and document clinical research data such as medical history and demographics; Maintain research documentation including status reports, progress notes, and participant logs to help ensure safety.7. Report and track adverse events (AEs). Reports serious AEs to PI, IRB and sponsor.8. Review and manage clinical research study databases.9. Educate staff regarding study procedures. 10. Document all protocol deviations, reconcile test article accountability at study close out and prepare summary report for sponsor.11. Complete, audit, correct, and relay case report forms (CRFs) to sponsor.12. Assist with negotiating study contract budget and payment terms.13. Maintain documents as required by FDA, ICH, GCP, and IRB regulatory guidelines.14. Maintain contact with IRB and prepare and submit IRB documents.15. Ensure proper collection, processing and shipment of specimens.16. Help determine personnel required to complete trial and develop the timeline for trial completion. Review study related data to assure compliance with study protocol.17. Assist with the preparation, coordination, and facilitation of sponsor monitoring visits, including responding to follow-up items and supporting timely resolution of findings.This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.Work Environment and Level of Frequency that may be required:Nearly Continuously: Office environment.Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).Physical Requirements and Level of Frequency that may be requiredNearly Continuously: Hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking, standing, sitting.Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelors degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.

Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.

Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.

Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Demonstrated experience coordinating and/or managing clinical trials involving the investigational use of medical devices and drugs, including studies conducted under IDE and IND requirements.

Special Instructions

• Requisition Number: PRN46042B
• Full Time or Part Time? Full Time
• Work Schedule Summary
• Department: 00917 - Vascular Surgery Development
• Location: Campus
• Pay Rate Range: 39300 to 72700
• Close Date: 11/28/2026
• Open Until Filled