Regulatory Affairs Specialist

Job Description

We are seeking a Clinical Regulatory Affairs Specialist to manage and plan regulatory affairs compliance for industry sponsors and/or sites within our network. This US-based, full‑time, fully remote position requires minimal supervision. Relocation assistance and sponsorship are not available.

• Establish and maintain a document management system for regulatory electronic files.
• Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors, and other networks.
• Ensure all regulatory documentation complies with local Standard Operating Procedures for format and content.
• Maintain critical documentation ensuring compliance.
• Modify and develop informed consent forms, and update and manage protocol, investigator drug brochure, and consent form modifications or amendments in compliance with IRB policy and HIPAA.
• Communicate time‑sensitive correspondence with sponsors and other stakeholders.
• Organize and process documentation for IRB submission for multiple trials.
• Process Protocol Deviations that meet the IRB reportable criteria.
• Submit urgent safety notifications to the IRB.
• Perform other duties as assigned.

• Associate’s Degree or higher preferred; high school diploma required (qualified experience may be substituted).
• 1+ year work experience in a clinical research, pharmaceutical, or site management organization, focused on regulatory affairs, highly desired.
• Knowledge of medical terminology, FDA, and other regulatory processes, highly preferred.

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community‑based clinical trials. SCRI has conducted more than 850 first‑in‑human clinical trials and contributed to the majority of new cancer therapies approved by the FDA in the past decade.

We are an equal‑opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.