Regulatory Affairs Coordinator
Sarah Cannon Research Institute
Summary
As the Regulatory Coordinator you are responsible for managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. In this position you will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.
Job description
- You will process regulatory document signature request through an electronic signature platform
- You will track documents pending site regulatory signatures
- You will provide site level regulatory support to the Clinical Operations' sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- You will establish and maintain a document management system for regulatory paper and electronic files
- You will maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. You will ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP's) for format and content
- You will maintain updated physician credentials for network participants and other critical documentation ensuring compliance
- You will triage site requests for regulatory support and identifies correct pathway for issue resolution
You should have for this position:
- An Associate Degree, preferably a Bachelor's Degree
- Regulatory experience is preferred
- Customer service experience is preferred
Requirements
- Associate Degree
- Bachelor's Degree preferred
- Regulatory experience preferred
- Customer service experience preferred
Benefits
- Comprehensive benefits
- Physical well-being support
- Mental well-being support
- Financial well-being support
- Competitive compensation package
- Annual bonus
- Long-term incentive opportunities
Company overview
Sarah Cannon Research Institute (SCRI) is a premier oncology research organization and global leader in community-based clinical trials. Founded in 2004 through a joint venture between Tennessee Oncology and Hospital Corporation of America, SCRI has established itself as one of the world's leading cancer research institutions. With headquarters in Nashville, Tennessee, the institute operates across more than 200 locations in over 20 U.S. states and the United Kingdom, bringing together more than 1,300 research physicians. SCRI specializes in conducting first-in-human clinical trials, having completed over 850 such studies since its inception, and has contributed significantly to the development of approximately 10 FDA-approved cancer therapies since 1999. The organization focuses primarily on oncology research while also expanding into cardiology, gastroenterology, and other therapeutic areas. SCRI's unique community-based model enables patients to access cutting-edge clinical trials close to home, bridging the gap between academic research centers and local healthcare providers. The institute employs 501-1,000 professionals and maintains strategic partnerships with pharmaceutical and biotechnology companies to advance cancer treatment innovations.