Sarah Cannon Research Institute · 3 weeks ago
Regulatory Affairs Specialist
United States
Full-time
Remote
Entry Level
1+ years expSarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. The Clinical Regulatory Affairs Specialist will manage and plan regulatory affairs compliance for industry sponsors and/or sites, ensuring adherence to regulatory standards and preparing for audits.
Research
No H1B
Responsibilities
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
Qualification
Required
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
Preferred
Associate's Degree or higher is preferred
Knowledge of medical terminology, FDA, other regulatory processes highly preferred
Benefits
Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities may be offered
Company
Sarah Cannon Research Institute
Sarah Cannon Research Institute is one of the world’s leading oncology research organizations conducting community-based clinical trials.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Amber Woodward-Smith
CFO
Recent News
Clinical Trials Arena
2026-08-15
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