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. Partnerships with individuals communities and many other entities are crucial to our work. Huntsman Cancer Institute values cancerrelated health equity and inclusion as integral to our guiding principle to serve our patients and their communities and our commitment to foster a culture of belonging for all within our organization. In your cover letter or during your interview process we invite you to share how your personal and 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 Institutes mission and this position. Learn more here

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 investigatorinitiated 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. ProblemSolving 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
Bachelors 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.