PS Regulatory Coordinator

Announcement Details Open Date 10/21/2025 Requisition Number PRN43374B Job Title PS Regulatory Coordinator Working Title PS Regulatory Coordinator Career Progression Track E Track Level FLSA Code Administrative Patient Sensitive Job Code? Yes Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary 40 hours per week; availability Monday through Friday, 7:30 a.m. - 5:30 p.m. VP Area U of U Health - Academics Department 00848 - Pediatric Administration Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range $39,300 - $68,349 Close Date 01/21/2026 Priority Review Date (Note - Posting may close at any time) Job Summary Job Summary The Department of Pediatrics, Division of Pediatric Neurology, at the University of Utah School of Medicine has an immediate opening for a Clinical Research Regulatory Coordinator. This position develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements. Oversees research study documents in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates (see the Summary Comparison for more information) 14.2% retirement contributions Generous paid leave time 11 paid Holidays per year 50% tuition reduction for employees, spouses, and dependent children Flex 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 Additional benefits information is available at https://benefits.utah.edu/. Responsibilities Essential Functions Supports all aspects of regulatory compliance. Prepares regulatory documents, including consent forms for submission to research review committees. Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Tracks study approvals and expirations to ensure uninterrupted project approval. Tracks sponsor and investigator-initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB). Submits study start-up applications, renewal applications and study progress reports to the IRB. Coordinates with study sponsor, investigator and IRB to complete study closure activities. Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission. Recommends and implements regulatory process improvements. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Maintains regulatory database. Generates ad hoc reports as requested. Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Work Environment and Level of Frequency that may be required : Nearly Continuously: Office environment. Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids). Physical Requirements and Level of Frequency that may be required: Nearly Continuously: Hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking, standing, sitting. Seldom: Bending, reaching overhead. Minimum Qualifications Bachelor's degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required. One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred. This position is patient-sensitive and must fulfill all associated requirements. 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. Preferences Department Specific Preferences Three or more years of industry sponsored clinical trials experience is preferred. Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; extensive understanding of research procedures. Experience with Medical Record Coding, familiarity with EMR and medical record structure and data location, proficiency in computers and software applications (MS Access), detail oriented, critical thinking skills is preferred. Self-motivated and flexible. Applicants will be screened according to preferences. Type Benefited Staff Special Instructions Summary 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 (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS' post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules. 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 patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients. All qualified individuals are strongly encouraged to apply. 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. The University of Utah is an Affirmative Action/Equal Opportunity employer and 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. Inquiries about the application of Title IX and its regulations may be referred to the Title IX 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/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action (OEO/AA). More information, including the Director/Title IX Coordinator's office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/ Online reports may be submitted at oeo.utah.edu https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. 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.