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Regulatory Affairs Coordinator II

Blue Ridge Cancer Care • Salem, VA, US • published 2026-10-06 07:33:52.836886

Description

Overview: Under minimal supervision is responsible for the research regulatory and administrative activities of clinical trials for the practice. Plays an integral role in the regulatory/compliance process of all clinical research conducted to include site qualification, and management of the study regulatory documents throughout the site’s participation. Collaborates with research staff and management on process improvement and QA initiatives. May train other employees on regulatory process. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards. Responsibilities: Job Description**Key Responsibilities** * In collaboration with investigators, responsible for tracking and completing protocol feasibility questionnaires. Coordinates Critical Document Collection to facilitate the timely opening of trials at the site. Communicates and collaborates with central operations and data man...

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