Study Coordinator

Job Summary Coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. Responsibilities Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria, and clarifies concerns with the Principal Investigator and sponsor. Attends and participates in investigator and staff meetings and advises the team regarding study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents information in source files and maintains status reports, progress notes, and subject logs to 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 reports for the sponsor. Completes, audits, corrects CRFs, and relays CRFs to the sponsor. Assists with negotiating contract budget and payment terms. Maintains documents as required by FDA guidelines. Maintains contact with IRB and prepares and submits IRB documents. Ensures proper collection, processing, and shipment of specimens. Performs functions required of the Clinical Research Assistant as necessary. Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project, and maintaining adequate resources for the Principal Investigator to accomplish their research objectives. Physical Requirements Nearly continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (e.g., typing), walking. Seldom: Bending, reaching overhead. Minimum Qualifications Bachelor’s degree in a related field or equivalent (one year of education can be substituted for two years of related work experience). IRB CITI Course in the Protection of Human Research Subjects must be obtained within six months of hire, and human‑relations and effective‑communication skills are required. Some departments may require IATA DGR training within six months of hire. 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. Applicants must demonstrate the potential to perform the essential functions of the job as outlined above. Additional Information This position may require the successful completion of a criminal background check and/or drug screening. Veterans’ preference is extended to qualified applicants. Reasonable accommodations in the application process will be provided to individuals with disabilities. Equal Employment Opportunity Statement 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. Please contact the Office of Equal Opportunity and Title IX for additional information or assistance. #J-18808-Ljbffr