University of Utah
Regulatory Coordinator
🇺🇸 Salt Lake City, UT
🕑 Full-Time
💰 $39K - $73K
💻 Other
🗓️ November 27th, 2025
IRB
Edtech.com's Summary
University of Utah is hiring a Regulatory Coordinator to develop and coordinate the submission of regulatory documents for the Population Science Trials Office at Huntsman Cancer Institute. The role ensures compliance with federal and institutional research guidelines by managing regulatory processes, preparing documents, communicating with relevant committees, and supporting study approvals.
Highlights
- Supports all aspects of regulatory compliance for clinical research.
- Prepares and submits regulatory documents including consent forms and protocol amendments to the Institutional Review Board (IRB).
- Tracks study approvals, expirations, renewals, and progress reports to maintain regulatory compliance.
- Coordinates study closure activities and maintains regulatory databases.
- Communicates with research committees, project sponsors, and staff to ensure accuracy and compliance.
- Bachelor’s degree in research or related field required, plus two years clinical trials/research experience or equivalency.
- Preferred qualifications include oncology clinical trial experience, regulatory experience, familiarity with FDA, OHRP, ICH GCP guidelines, and technical writing skills.
- Proficient use of Microsoft Office applications (Word, PowerPoint, Excel, Project) and project management tools expected.
- Compensation ranges from $39,300 to $72,700 annually.
- Position is full-time, administrative code, supporting cancer research compliance at Huntsman Cancer Institute serving multiple western states.
Regulatory Coordinator Full Description
Regulatory Coordinator
Announcement
Details
Open Date | 11/25/2025
Requisition Number | PRN43693B
Job Title | Regulatory Coordinator
Working Title | Regulatory Coordinator
Career Progression Track | E
Track Level |
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 | President
Department | 01345 - HCI Clinical Resrch Compliance
Location | Campus
City | Salt Lake City, UT
Type of Recruitment | External Posting
Pay Rate Range | 39300 to 72700
Close Date | 02/23/2026
Priority Review Date (Note - Posting may close at any time) |
Job Summary | Develops and coordinates the submission of regulatory documents for the Population Science Trials Office at Huntsman Cancer Institute to ensure compliance with governing requirements.
Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide.
In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include a description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
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 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.
Problem Solving
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.
The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload, and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow-through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.
Work Environment and Level of Frequency typically required Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead.
Requisition Number | PRN43693B
Job Title | Regulatory Coordinator
Working Title | Regulatory Coordinator
Career Progression Track | E
Track Level |
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 | President
Department | 01345 - HCI Clinical Resrch Compliance
Location | Campus
City | Salt Lake City, UT
Type of Recruitment | External Posting
Pay Rate Range | 39300 to 72700
Close Date | 02/23/2026
Priority Review Date (Note - Posting may close at any time) |
Job Summary | Develops and coordinates the submission of regulatory documents for the Population Science Trials Office at Huntsman Cancer Institute to ensure compliance with governing requirements.
Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide.
In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include a description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
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 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.
Problem Solving
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.
The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload, and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow-through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.
Work Environment and Level of Frequency typically required Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required Nearly 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 not responsible for providing patient care.
Preferences | · One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred. · Oncology clinical trial experience highly preferred. · Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines. · Knowledge of the clinical development process sufficient to effectively direct and manage multiple projects and timelines. · Strong attention to detail, establishing priorities, and adhering to deadlines. · Able to show initiative and work independently, take initiative and complete tasks to meet deadlines. · Excellent interpersonal communication (including oral and written) and leadership skills also required. · Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools. · SOCRA or ACRP certification. Type | Benefited Staff
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 experience, an understanding of medical terminology and technical writing experience preferred. · Oncology clinical trial experience highly preferred. · Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines. · Knowledge of the clinical development process sufficient to effectively direct and manage multiple projects and timelines. · Strong attention to detail, establishing priorities, and adhering to deadlines. · Able to show initiative and work independently, take initiative and complete tasks to meet deadlines. · Excellent interpersonal communication (including oral and written) and leadership skills also required. · Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools. · SOCRA or ACRP certification. 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.
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 (*).
- * 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
- * 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
- Do you have any current relatives working in HCI?
(Open Ended Question)
Applicant Documents
Required Documents
- Resume
Optional Documents
- Cover Letter
- Historical Only – Do Not Use – See Document Description for More Information – Addendum to the University of Utah – Veteran Only
- 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
Similar Jobs
Associate Director for Strategic Initiatives
Syracuse University
🇺🇸 Syracuse, NY
Specialist, Business Services
St. Louis Community College
🇺🇸 St. Louis, MO
Administrative and Academic Services Specialist
Montana State University
🇺🇸 Bozeman, MT
Administrative Support Specialist
University of North Carolina - Charlotte
🇺🇸 Hybrid - Charlotte, NC
Associate Dean Arts, Business, Humanities, and Social Sciences
Virginia's Community College System
🇺🇸 Hybrid - Hampton, VA
