University of Utah logo

University of Utah

PS Regulatory Coordinator

🇺🇸 Salt Lake City, UT

🕑 Full-Time

💰 $48K - $68K

💻 Other

🗓️ July 4th, 2025

IRB

Edtech.com's Summary

University of Utah is hiring a PS Regulatory Coordinator. This role involves developing and coordinating the submission of regulatory documents to ensure compliance with governing requirements and supporting all aspects of regulatory compliance within clinical research settings.

Highlights

  • Prepare regulatory documents including consent forms for research review committees.
  • Communicate with research committees, sponsors, and project staff to ensure regulatory accuracy.
  • Track study approvals, expirations, amendments, renewals, and progress reports with the Institutional Review Board (IRB).
  • Coordinate study closure activities in collaboration with sponsors, investigators, and the IRB.
  • Assist investigators with clinical research policies, process guidance, and form preparation.
  • Recommend and implement improvements to regulatory processes.
  • Maintain knowledge of federal and institutional research guidelines and manage regulatory databases.
  • Generate ad hoc reports as needed.
  • Required qualifications include a Bachelor's degree in research or related area plus two years of clinical trials/research experience; regulatory experience, medical terminology understanding, and technical writing preferred.
  • Compensation range is $47,650 - $68,349 annually.

PS Regulatory Coordinator Full Description


Toggle navigation  

PS Regulatory Coordinator
Announcement
 Details 
Open Date  | 07/02/2025
Requisition Number  | PRN42381B
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
Shift  | Day
Work Schedule Summary  |
VP Area  | U of U Health - Academics
Department  | 00239 - Pulmonary
Location  | Campus
City  | Salt Lake City, UT
Type of Recruitment  | External Posting
Pay Rate Range  | $47,650 - $68,349
Close Date  | 10/02/2025
Priority Review Date (Note - Posting may close at any time)  |
Job Summary  | Develops and coordinates the submission of regulatory documents to ensure compliance with governing requirements.
Responsibilities  | 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.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 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  |
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.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
  1. * Do you have a Bachelor's degree in a research or related area or equivalency? (2 years related work experience may be substituted for 1 year of education). 
    • No
    • Yes
  2. * How many years of clinical trials/research experience do you have? 
    • Less than 2 years
    • 2 years or more, but less than 4 years
    • 4 years or more, but less than 6 years
    • 6 years or more, but less than 8 years
    • 8 years or more
Applicant Documents
Required Documents
Optional Documents
  1. Resume
  2. Cover Letter
  3. Historical Only – Do Not Use – See Document Description for More Information – Addendum to the University of Utah – Veteran Only
  4. Historical Only – Do Not Use – See Description for More Information – Appropriate discharge document (such as DD-2214) – Veteran Only
 University Human Resource Management 
 250 East 200 South, Suite 125 Salt Lake City, UT 84111
 Contact us: (801) 581-2169 By Email: employment@utah.edu 

 
 To ensure the security of your data, you will be logged out due to inactivity in 3 minutes at
 .

 Any data not saved will be lost.

 Click 'OK' to keep your session active.