Clinical Research Coordinators (Non-R.N.)

About the Role

The Division of Cardiology in the Department of Pediatrics at the University of Utah Spencer F. Eccles School of Medicine is seeking a Clinical Research Coordinator. This position will coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations. The role involves implementing processes, organizing study team efforts, and coordinating research procedures, study visits, and follow-up care.

Responsibilities

• Coordinate day-to-day clinical trial activities in adherence to GCPs, study protocols, and applicable regulations.
• Implement processes and organize efforts within the study team to achieve objectives, including research procedures, study visits, and follow-up care.
• Create and maintain tools and documentation to track study metrics, providing updates to management.
• Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities.
• Maintain source documents and report adverse events.
• Recruit, screen, enroll, and obtain consent from study participants.
• Collect and maintain patient and laboratory data.
• Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies.
• Assess protocol for clarity and subject safety, review inclusion/exclusion criteria, and clarify concerns with the Principal Investigator and sponsor.
• Attend and participate in Investigator and staff meetings; advise the team regarding specific study assignments and timelines.
• Explain and obtain informed consent, medical history, and demographics; document in source files.
• Determine length of visits and coordinate related facility and equipment availability.
• Report and track adverse events (AE) and report serious AEs to IRB and sponsor.
• Complete, audit, and correct CRFs, and relay CRFs to sponsor.
• Maintain documents as required by FDA guidelines.
• May maintain contact with IRB and prepare/submit IRB documents.
• May ensure proper collection, processing, and shipment of specimens.
• May perform functions required of the Clinical Research Assistant as necessary.
• Perform other related duties as assigned.

Requirements

• Bachelor’s degree (or equivalency) with up to 2 years of directly related work experience or a master’s (or equivalency) degree.
• 1 year of higher education can be substituted for 1 year of directly related work experience (e.g., bachelor’s degree = 4 years of related work experience).

Preferences

• Education & Certification: Bachelor’s degree in a life science or health-related field. IRB CITI Certification in the Protection of Human Research Subjects (or ability to obtain within three weeks of hire).
• Regulatory Knowledge: Foundational knowledge of Good Clinical Practices (GCP), FDA guidelines, HIPAA, and IRB regulations. Familiarity with medical terminology and clinical research procedures.
• Technical Skills: Proficiency in Microsoft Office Suite, REDCap, and ability to quickly learn new clinical trial management software.
• Patient Care & Communication: Excellent interpersonal, oral, and written communication skills. Ability to provide age-appropriate care and interact effectively with diverse patient populations. Strong human relations skills with a focus on patient advocacy and ethics.
• Operational Strengths: Attention to detail and high level of organizational accuracy. Proven ability to function independently and manage multiple priorities in a fast-paced environment.

Benefits

• Comprehensive health care coverage at affordable rates.
• 14.2% retirement contributions.
• Generous paid leave time and 11 paid holidays per year.
• 50% tuition reduction for employees, spouses, and dependent children.
• University-provided basic employee life insurance coverage equal to a salary of up to $25,000.
• Variety of elective insurance coverage, including life insurance, short- and long-term disability, accidental death & dismemberment, accident, critical illness, hospital indemnity, and pet insurance.
• Free transit on most UTA services.
• Employee discounts on a variety of products and services, including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel.
• Professional development opportunities.

Additional benefits information is available at https://benefits.utah.edu/.

Employee Health Requirements

This position is patient-sensitive and requires fulfillment of all associated vaccination requirements, or approval for an exemption, prior to the first day of work. Immunizations are required according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Pay

Expected pay range: $38,500 to $52,314.

Schedule

Full-time position. Work schedule: Monday – Friday, 8:00 a.m. – 4:30 p.m. Hours may vary based on operational needs, with occasional weekends/evenings required.