Research Regulatory Affairs Specialist
Sarah Cannon Research Institute
Summary
Research Regulatory Affairs Specialist primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position 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. The Regulatory Affairs Specialist I will maintain a full study workload with minimal supervision.
Job description
Duties include and are not limited to:
- Establishes and maintains a document management system for regulatory electronic files
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content
- Maintains critical documentation ensuring compliance
- Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA. This includes time sensitive correspondence with sponsors and other stakeholders.
- Organizes and processes documentation for IRB submission for multiple trials
- Processing of Protocol Deviations that meet the IRB reportable criteria
- Submits urgent safety notifications to the IRB
- Other duties as assigned
Qualifications for success include:
- Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education
- 1+ year work experience in a clinical research, pharmaceutical, site management organization highly desired focused in required regulatory affairs
- Knowledge of medical terminology, FDA, other regulatory processes highly preferred
Requirements
- High school graduation diploma required
- Associate's Degree or higher is preferred
- 1+ year work experience in clinical research, pharmaceutical, or site management organization highly desired
- Knowledge of medical terminology, FDA, and other regulatory processes highly 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.