University of Utah PS Regulatory Coordinator in Salt Lake City, Utah
Open Date 05/26/2021
Requisition Number PRN26295B
Job Title PS Regulatory Coordinator
Working Title PS Regulatory Coordinator
Job Grade E
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area U of U Health - Academics
Department 00952 - Division of Epidemiology
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 64349
Open Until Filled Yes
Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.
This position is considered Category IIA : Not required on campus and has the ability to telework remotely for the duration of the University of Utah’s response to COVID -19. An employee hired into this role will be responsible for providing space, telephone, printing, networking and/or internet capabilities at the telecommute location and agree to the terms of the University of Utah campus and Health Academics COVID -19 Telecommuting Agreement.
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 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.
Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency 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.
This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.
Type Benefited Staff
Special Instructions Summary
The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:
Director/ Title IX Coordinator
Office of Equal Opportunity and Affirmative Action ( OEO /AA)
135 Park Building
Salt Lake City, UT 84112
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
To inquire about this posting, email:firstname.lastname@example.org (%email@example.com) or call 801-581-2300.
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.