Regulatory Specialist 1 or 2 (Research Professional 1 or 2)

Job Class: 8351 RF or 8352 RF Research Professional 1 or 2 - Regulatory Affairs Specialist. Working Title: Regulatory Specialist 1 or 2 Supervisor: Deb Mailand. About the Job:In close partnership with the Program Manager(s) (PM), the Regulatory Specialist (RS) facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory documents and standards within the group. Responsibilities include: Perform regulatory processes necessary to make clinical trials available to patients following federal regulations, good clinical practice as well as sponsor and University policies. This includes: creating and maintaining regulatory documents, ensuring all are filed and archived properly; creating and adapting subject consent forms in compliance with sponsor and local standards; acting as a liaison with sponsor, principal investigator, research coordinators, review committees and monitors (internal & external); addressing regulatory issues of st...Specialist, Clinical Research, Regulatory, Project Manager, Professional, Program Manager, Business Services