Details **Open Date** 08/27/2024 **Requisition Number** PRN39685B **Job Title** Regulatory Coordinator **Working Title** Regulatory Coordinator **Job Grade** E **FLSA Code** Administrative **Patient Sensitive Job Code?** No **Standard Hours per Week** 40 **Full Time or Part Time?** Full Time **Shift** Day **Work Schedule Summary** **VP Area** U of U Health - Academics **Department** 00251 - Physical Med & Rehab - Oper **Location** Campus **City** Salt Lake City, UT **Type of Recruitment** External Posting **Pay Rate Range** $58,000-$68,000 **Close Date** **Open Until Filled** Yes **Job Summary** Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements. Reviews, maintains, and audits essential study data/documents to ensure quality assurance. **Responsibilities** **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. **Essential Functions** 1.Supports all aspects of regulatory compliance. 2. Checks the accuracy, completeness, and timelines of research data abstracted from study source documents. 3. Assists in preparing regulatory documents, including consent forms for submission to research review committees. 4. Maintains regulatory binders at the main site. 5. Communicates with research committees, administrative units, study sponsors and study staff to ensure the accuracy of regulatory documents and submissions. 6. Travels between sites to review study source documents for accuracy and proper documentation. 7. Partners with clinical research staff and investigators to address concerns and communicate findings. 8. Manage, prioritize, and routinely report progress on multiple projects. 9. Tracks study approvals and expirations to ensure uninterrupted project approval. 10. Tracks sponsor and investigator-initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board ( IRB ). 11. Prepare and be available for monitoring visits at the main site. 12. Submits study renewal applications and study progress reports to the IRB . 13. Coordinates with study sponsor, investigator and IRB to complete study closure activities. 14. Assists investigators and others involved in clinical research with process and policy issues. Guides form preparation and submission. 15. Recommends and implements regulatory process improvements. 16. Maintains current knowledge of federal and institutional guidelines and requirements governing research. 17. Maintains regulatory database. 18. Generates ad hoc reports as requested. Excellent organizational skills with high attention to detail are required. **Problem-Solving** This position utilizes federal and institutional guidelines and requirements to inform and complete the submission of regulatory documents. This position also negotiates with University of Utah research committees and sponsors to ensure full compliance and communication. **Comments** This position requires a sophisticated understanding of regulatory requirements. The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Some remote work is available. **Physical Requirements and Level of Frequency that may be required** Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Work with large regulatory binders on site. Seldom: Bending, lifting and 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 not responsible for providing patient care. **Preferences** One year of regulatory or study monitoring experience is preferred **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.