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. Learn more about the great benefits of working for University of Utah: benefits.utah.edu The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget. 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 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. 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 education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Regulatory Affairs Specialist (Life Sciences), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience. 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 timelinesStrong attention to detail, establishing priorities, and adhering to deadlinesAble to show initiative and work independently, take initiative and complete tasks to meet deadlinesExcellent interpersonal communication (including oral and written) and leadership skills.Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools SOCRA or ACRP certification Bachelor's degree in a research or related area plus two years clinical trials/research experience or equivalency; demonstrated human relations and effective communication skills. Special Instructions Requisition Number: PRN46478B Full Time or Part Time? Full Time Work Schedule Summary Department: 01345 - HCI Clinical Resrch Compliance Location: Campus Pay Rate Range: $32,904 to $75,487 Close Date: 01/11/2027 Open Until Filled To apply, visit <a href=""https://apptrkr.com/9896381"">https://utah.peopleadmin.com/postings/210785 Copyright ©2025 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency je-ac50538eaa3343fcbbec8543fc0723f7