Regulatory Affairs Specialist: Clinical Trials & Compliance

Sarah Cannon Research Institute; Tennessee; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Total Rewards benefits

Competitive compensation

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and sites within networks. You will work with regulatory affairs management, department director, and investigators to ensure timely audits and maintain a full study workload with minimal supervision.

The role requires knowledge of FDA, GCP, and regulatory processes, with an emphasis on documentation, IRB submissions, and HIPAA considerations.

Qualifications

• Associate degree or higher preferred; high school diploma required; qualifying experience may substitute education.

Responsibilities

• Establishes and maintains a document management system for regulatory electronic files.
• Maintains FDA and GCP required regulatory documentation for sites, studies, sponsors and networks.
• Maintains critical documentation ensuring compliance.
• Modifies and updates informed consent forms and manages protocol, investigator drug brochure, and consent form changes per IRB/HIPAA.
• Organizes IRB submissions for multiple trials.
• Processes Protocol Deviations that meet IRB reportable criteria.
• Submits urgent safety notifications to the IRB.
• Other duties as assigned.

Skills

Regulatory affairs

Clinical research

FDA regulatory processes

Education

Associate's degree or higher preferred

Job description

Sarah Cannon Research Institute (SCRI) is seeking a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and sites within networks. You will work with regulatory affairs management, department director, and investigators to ensure timely audits and maintain a full study workload with minimal supervision.

The role requires knowledge of FDA, GCP, and regulatory processes, with an emphasis on documentation, IRB submissions, and HIPAA considerations.