Regulatory Coordinator

University of Utah•Salt Lake City, UT

1d•$39,300 - $72,700•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.