Regulatory Coordinator Sr

Job Summary
The candidate will be responsible for project management support and facilitating the startup activities of therapeutic oncologybased investigatorinitiated trials (IITs) to ensure timely activation. Responsibilities include having a strong knowledge of clinical trial regulatory and compliance processes communicating expectations as they relate to IIT protocol development with numerous relevant stakeholders and generating reports for IIT activation metrics. Serving as a member in the Research Compliance Office RCO department the candidate may also be responsible for providing quality assurance oversight of clinical trials via monitoring and auditing trial progress in the event of an FDA inspection. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position responsibilities. This is a hybrid position requiring inperson and remote work. 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
Provide project management support for investigatorinitiated trials (IITs) conducted at HCI to ensure timelines are met and trials are activated efficiently. Prepares and ensures submission of appropriate documents to the IRB prior to study activation. Prepares and facilitates advanced regulatory submissions including IND and/or IDE applications and reports to the FDA . This includes Expanded Access Single Patient IND requests. Analyzes and mitigates complex nonroutine regulatory issues and workflow problems. Acts as a liaison between the University parties (PI regulatory team study team etc. and study sponsors and/or regulatory agencies on all issues pertaining to regulatory compliance. Serves as a resource to the clinical research staff on advanced regulatory issues and concepts. Drafts formats and edits informed consent forms (ICFs). Works directly with Principal Investigators (PIs) and study team members to ensure stipulations from approving bodies are addressed appropriately and in a timely manner. Provides consultation and assistance to the PI and the study team on the process for trial activation at HCI . Manages and tracks timelines across various teams that are working in tandem during the protocol development process to ensure all parties are ready to activate a new IIT . In collaboration with the Protocol Writing team serves as the point of contact for Protocol Development on IIT projects. Tracks the required approvals necessary prior to study activation. Maintains current knowledge regarding 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. Prepare documents regarding protocol activation metrics for HCI Senior Leadership. Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs.

Minimum Qualifications
Bachelors degree in a research or related area plus four 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. Three years of regulatory experience an understanding of medical terminology and technical writing experience required. This position is not responsible for providing patient care. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.