Clinical Research Coord

About the role

The Division of Vascular Surgery at the University of Utah has an immediate opening for a Clinical Research Coordinator. This position will assist in facilitating the conduct of clinical research by performing research duties for Vascular Surgeon Research Investigators, coordinating technical and administrative details for sponsor and physician-initiated studies, and supporting the Principal Investigator and study team in achieving study integrity and objectives.

Responsibilities

• Screen and recruit participants for clinical research studies.
• Understand and obtain informed consent from eligible study participants; document the process and write informed consent documents under the supervision of the study investigator.
• Attend and actively participate in study team meetings; assume leadership roles within study teams.
• Schedule study visits and coordinate related facility and equipment availability.
• Assess research protocols for clarity and participant safety; review inclusion/exclusion criteria and clarify concerns with the Principal Investigator and sponsor.
• Collect and document clinical research data such as medical history and demographics; maintain research documentation including status reports, progress notes, and participant logs.
• Report and track adverse events (AEs); report serious AEs to PI, IRB, and sponsor.
• Review and manage clinical research study databases.
• Educate staff regarding study procedures.
• Document all protocol deviations, reconcile test article accountability at study closeout, and prepare summary report for sponsor.
• Complete, audit, correct, and relay case report forms (CRFs) to sponsor.
• Assist with negotiating study contract budget and payment terms.
• Maintain documents as required by FDA, ICH, GCP, and IRB regulatory guidelines.
• Maintain contact with IRB and prepare and submit IRB documents.
• Ensure proper collection, processing, and shipment of specimens.
• Help determine personnel required to complete trial and develop the timeline for trial completion; review study-related data to assure compliance with study protocol.
• Assist with the preparation, coordination, and facilitation of sponsor monitoring visits, including responding to follow-up items and supporting timely resolution of findings.

Minimum Qualifications

• Bachelor’s 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 of professional research experience.
• 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.
• Knowledge of Good Clinical Practices, FDA, HIPAA, and IRB regulations; an understanding of research procedures; and the ability to function independently.
• This position is patient-sensitive and requires immunization according to CDC standards and hospital policy; limited exemptions may be made for documented medical contraindications or religious beliefs.

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.

Work Environment

• Nearly Continuously: Office environment.
• Seldom: Exposure to infectious disease, oils, or cutting fluids.

Physical Requirements

• Nearly Continuously: Hearing, listening, talking.
• Often: Repetitive hand motion (such as typing), walking, standing, sitting.
• Seldom: Bending, reaching overhead.