Clinical Research Coordinators (Non-R.N.)

Job Summary

The Division of Hospital Medicine at the University of Utah Spencer F. Eccles School of Medicine has an immediate opening for a Clinical Research Coordinator in the Department of Pediatrics. This position will coordinate clinical trial activities, implement processes, and manage study team efforts.

About the Role

This position works under the direction of the Primary Investigator (PI) and is currently budgeted at 30 hours per week. Opportunities for a 40-hour per week position may be available in the future, contingent upon funding and departmental needs.

Responsibilities

• Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations.
• Implement processes and organize efforts within the study team to achieve objectives, coordinating 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 and questions with the Principal Investigator and sponsor.
• Attend and participate in Investigator and staff meetings, informing the team regarding specific study assignments and timelines.
• Inform team regarding specific study assignments and timelines.
• Explain and obtain informed consent, medical history, and demographics; document in source file and maintain with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Determine length of visits and coordinate related facility and equipment availability.
• Report and track adverse events (AE).
• Report serious AEs to IRB and sponsor.
• Document all protocol deviations, reconcile test article accountability at study close out, and prepare summary report for sponsor.
• Complete, audit, correct CRFs, relay CRFs to sponsor.
• Absorb and assist with negotiating contract budget and payment terms.
• Maintain documents as required by FDA guidelines.
• Prepare and submit IRB documents.
• Ensure proper collection, processing, and shipment of specimens.
• Perform functions required of the Clinical Research Assistant as necessary.

Qualifications

• Requires a bachelor's (or equivalency) with up to 2 years of directly related work experience or a master's (or equivalency) degree.
• Fluency in Spanish, both oral and written, is preferred.
• Excellent written and verbal communication skills are required.

Benefits

The University of Utah offers a comprehensive benefits package including:

• Excellent health care coverage at affordable rates
• 14.2% retirement contributions
• Generous paid leave time
• 11 paid Holidays per year
• 50% tuition reduction for employees, spouses, and dependent children
• Flexible spending accounts
• 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.
• 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

Employee Health Requirements

This position is patient-sensitive and requires fulfilling all associated vaccination requirements, or being approved for an exemption, prior to the first day of work.