"Regulatory Coordinator"

Regulatory Coordinator

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 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:

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 SolvingThis 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 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 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 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

Special Instructions

Requisition Number: PRN43693B Full Time or Part Time? Full Time Work Schedule Summary: Department: 01345 - HCI Clinical Resrch Compliance Location: Campus Pay Rate Range: 39300 to 72700 Close Date: 2/23/2026 Open Until Filled: