PS Regulatory Coordinator

DetailsOpen Date 05/13/2024Requisition Number PRN38522BJob Title PS Regulatory CoordinatorWorking Title PS Regulatory CoordinatorJob Grade EFLSA Code AdministrativePatient Sensitive Job Code? YesStandard Hours per Week 40Full Time or Part Time? Full TimeShift DayWork Schedule SummaryThis role may accommodate a hybrid remote and in person work schedule.VP Area U of U Health - AcademicsDepartment 00239 - PulmonaryLocation CampusCity Salt Lake City, UTType of Recruitment External PostingPay Rate Range 39300 to 68349Close DateOpen Until Filled YesJob SummaryDevelops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.ResponsibilitiesSupports 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 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.Work Environment and Level of Frequency typically requiredNearly Continuously: Office environment.Physical Requirements and Level of Frequency that may be requiredNearly Continuously: Sitting, hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking.Seldom: Bending, reaching overhead.Minimum QualificationsBachelor’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.PreferencesRegulatory experience preferred.Type Benefited StaffSpecial Instructions SummaryAdditional InformationThe 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.eduhttps://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.