PS Regulatory Coordinator

Position Number: 9711837
Location: Salt Lake City, United States
Position Type: Laboratory and Research

PS Regulatory Coordinator

Job Summary

Regulatory coordination is a specialized function within clinical trials operations responsible for all regulatory processes across multiple studies in compliance with local and federal regulations, Standard Operating Procedures (SOP's), and study-specific protocols.

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

Supports all aspects of regulatory compliance as it pertains to the essential components of a clinical trial including submissions to IRB and internal ancillary committees.
Prepares regulatory documents, including informed consent form, and other required regulatory documentation;
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 documents database.
Generates ad hoc reports as requested.
Coordinates and performs responsibilities related to research participants including developing informed consents overseeing appropriate approval of all patient related materials by appropriate regulatory review committees.
Prepares for and participates in audits made by sponsors or federal agencies during course and at the close of the study.
Prepares, submits and maintains IRB and/or other regulatory documents and research correspondence for all investigator-initiated, NCI and industry sponsored clinical studies.

The incumbent decides how to best accomplish the daily requirements of various protocol regulatory requirements, prioritizes and delegates workload and establishes systems needed to achieve specific regulatory goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved.

The incumbent is expected to closely monitor studies in which experimental equipment and drugs are utilized. Federal regulations mandate the regulatory requirements for use of investigational new drugs or devices and the subjects participating in research studies often have no other option for recovery. Analysis on critical research studies is required in order to maintain accurate regulatory record compliance with all aspect of the research study in accordance with federal regulations.

The incumbent utilizes federal and institutional guidelines and requirements to inform and complete submission of regulatory activities. This position negotiates and communicates extensively with University research protection committees and sponsors to ensure full compliance.
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.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.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.

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

Special Instructions

Requisition Number: PRN45613B
Full Time or Part Time? Full Time
Work Schedule Summary:
Department: 01167 - HCI Clinical Trials Operations
Location: Campus
Pay Rate Range: 39300 to 63787.15
Close Date: 10/20/2026
Open Until Filled:

To apply, visit <a href=""https://apptrkr.com/9711837"">https://utah.peopleadmin.com/postings/205716

Job Details