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 and questions with the Principal Investigator and sponsor. Attends and participates in investigator and staff meetings, advising the team on specific study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents data in source files and maintains historical records, 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; reports serious adverse events to the Institutional Review Board (IRB) and sponsor. Documents all protocol deviations, reconciles test article accountability at study closeout, and prepares summary reports for the sponsor. Completes, audits, corrects case report forms (CRFs), and relays CRFs to the sponsor. Maintains documents as required by FDA guidelines. Maintains contact with the IRB and prepares and submits IRB documents as needed. Ensures proper collection, processing, and shipment of specimens. Enters study‑relevant data in required databases as outlined by protocol and department standard operating procedures. Incumbents are responsible for coordinating the daily operations of their assigned research team, ensuring orderly and safe flow of the research project and maintaining adequate resources for the Principal Investigator to accomplish research objectives. 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 certificate must be obtained within six months of hire, and demonstrated human relations and effective communication skills are also required. Some departments may require IATA DGR training within six months of hire. The position is patient‑sensitive and requires fulfillment of all associated vaccination requirements, or an approved exemption, prior to the first day of work. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Preferences ACRP or SOCRA certification. Experience with REDCap, EPIC, and Microsoft Applications. 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 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 TitleIX and 34CFR part106. Inquiries about the application of TitleIX and its regulations may be referred to the TitleIX Coordinator, to the Department of Education, Office for Civil Rights, or both. 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/TitleIX Coordinator in the Office of Equal Opportunity and TitleIX. #J-18808-Ljbffr