Clinical Research Coordinators (Non-R.N.)

Clinical Research Coordinators (Non-R.N.) Job Summary This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. 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. 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. Work under the direction of the Primary Investigator (PI). Benefits: Learn more about the great benefits of working for University of Utah: benefits.utah.edu Responsibilities Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor. Completes, audits, corrects CRFs, relays CRFs to sponsor. Assists with negotiating contract budget and payment terms. Maintains documents as required by FDA guidelines. May maintain contact with IRB and prepare and submit IRB documents. May ensure proper collection, processing and shipment of specimens. May perform functions required of the Clinical Research Assistant as necessary. Minimum Qualifications One year of higher education can be substituted for one year of directly related work experience. Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience. Preferred Experience Experience in clinical research coordination, including GCP, protocol review, and adverse event reporting. Additional Information The University is a participating employer with Utah Retirement Systems (URS). Eligible new hires with prior URS service may elect to enroll in URS if they make the election before they become eligible for retirement. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS post‑retirement rules and restrictions. This position may require the successful completion of a criminal background check and/or drug screen. The University of Utah values candidates who have experience working in settings with students and possess a strong commitment to improving access to higher education. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. Consistent with state and federal law, the University of Utah does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy‑related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: Online reports may be submitted at oeo.utah.edu They also provide information about safety and security‑related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South. Required Documents Resume Cover Letter University Human Resource Management 250 East 200 South, Suite 125 Salt Lake City, UT 84111 Contact us: View phone number on click.appcast.io By Email: View email address on click.appcast.io #J-18808-Ljbffr