Regulatory Specialist - (Minneapolis, MN)

The Hennepin Healthcare Research Institute has a current opening for a full time Regulatory Specialist to support the clinical research being conducted by Dr. Gavin Bart. JOB DETAILS: Responsible for regulatory aspects of clinical research. Systematically coordinates and organizes protocols. ESSENTIAL JOB FUNCTIONS: Support regulatory obligations in the course of clinical research. Prepare and submit documentation to regulatory agencies. Ensure company compliance with all regulations and laws pertaining to company business. Compile and maintain appropriate technical documents for regulatory submissions. Systematically coordinates and organizes protocols. Accurately writes sections of protocol. Acts as a resource person to other medical staff regarding study protocol and interpretations Develop and maintain internal regulatory binders and prepare documentation for external regulatory binders