Regulatory Coordinator

University of Utah; Salt Lake City (UT); On-site; USD 33,000 - 75,000; Full time

Job summary

Huntsman Cancer Institute at the University of Utah is seeking a Regulatory Coordinator to develop and coordinate regulatory submissions to ensure compliance with governing requirements. The role supports regulatory processes, communications with IRB, and trackings of approvals and expirations.

Position is full-time at the Campus location, with duties including document preparation, policy guidance, and regulatory reporting to maintain study integrity and compliance with FDA/ICH/GCP guidelines.

Qualifications

• Bachelor's degree in a research or related area plus two years of clinical trials/research experience.
• Equivalency statement allowing one year of higher education to substitute for one year of related work experience.

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.
• Submits study renewal applications and study progress reports to the IRB.
• Maintains regulatory database.
• Generates ad hoc reports as requested.

Skills

Regulatory knowledge

Medical terminology

Technical writing

Communication skills

Microsoft Office

Education

Bachelor's degree

Clinical trials/research experience

Job description

Regulatory Coordinator

Job Summary

Develops and coordinates the submission of regulatory documents forthe Population Science Trials Office at Huntsman Cancer Instituteto 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 – withimpact worldwide.

In your cover letter or during your interview process, we inviteyou to share how your professional experiences have prepared you toserve as a member of our team as we work to reduce the cancerburden experienced by all people and communities. This may includedescription of your prior experiences related to research,prevention, clinical care, community engagement/outreach, training,administration, or other areas relevant to Huntsman CancerInstitute's mission and this position.

Learn more about the great benefits of working forUniversity of Utah: benefits.utah.edu

The department may choose to hire at any of the below joblevels and associated pay rates based on their business need andbudget.

Responsibilities

Essential Functions:

1. Supports all aspects of regulatory compliance.
2. Prepares regulatory documents, including consent forms for submission to research review committees.
3. Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
4. Tracks study approvals and expirations to ensure uninterrupted project approval.
5. Tracks sponsor and investigator-initiated amendment notifications and submits amended protocols, summaries, and consents to the Institutional Review Board (IRB).
6. Submits study renewal applications and study progress reports to the IRB.
7. Coordinates with study sponsor, investigator, and IRB to complete study closure activities.
8. Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission.
9. Recommends and implements regulatory process improvements.
10. Maintains current knowledge of federal and institutional guidelines and requirements governing research.
11. Maintains regulatory database.
12. Generates ad hoc reports as requested.

Problem Solving

This position utilizes federal,institutional guidelines and requirements to inform and completes 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.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Minimum Qualifications

EQUIVALENCY STATEMENT: 1 year of higher educationcan be substituted for 1 year of directly related work experience(Example: bachelor's degree = 4 years of directly related workexperience).

Department may hire employee at one of the following joblevels: Regulatory Affairs Specialist (LifeSciences), II: Requires a bachelor's (or equivalency) + 4years or a master's (or equivalency) + 2 years of directly relatedwork experience.

Preferences

• One year of regulatory experience, an understanding of medicalterminology 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 clinical development process sufficient toeffectively direct and manage multiple projects and timelines
• Strong attention to detail, establishing priorities, andadhering to deadlines
• Able to show initiative and work independently, take initiativeand complete tasks to meet deadlines
• Excellent interpersonal communication (including oral andwritten) and leadership skills.
• Proficient in standard Microsoft office applications includingWord, PowerPoint, Excel, Project, and other project managementtools
• SOCRA or ACRP certification

Bachelor's degree in a research or related area plus two yearsclinical trials/research experience or equivalency; demonstratedhuman relations and effective communication skills.

Requisition Number: PRN46478B

Full Time or Part Time? Full Time

Department: 01345 - HCI Clinical Resrch Compliance

Location: Campus

Pay Rate Range: $32,904 to $75,487

Close Date: 01/11/2027