Oncology Research Regulatory Affairs Specialist

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

Job summary

Sarah Cannon Research Institute (SCRI) seeks a detail‑oriented Research Regulatory Affairs Specialist to join our expanding oncology programs. You will manage regulatory compliance for sponsors and sites, collaborate with regulatory affairs leads, and help prepare audits while meeting deadlines.

You will maintain regulatory documentation, update informed consent and trial materials, coordinate IRB submissions, and ensure HIPAA and SOP adherence across multiple trials in a fast-paced,

Qualifications

• 1+ year work experience in clinical research or regulatory affairs.
• Knowledge of FDA processes and medical terminology.
• Experience maintaining regulatory documentation and SOP compliance.

Responsibilities

• Establishes and maintains regulatory document management system for electronic files.
• Maintains FDA and GCP regulatory documentation for sites, studies, sponsors and networks; ensures SOP compliance.
• Modifies and updates informed consent forms; manages protocol amendments per IRB policy and HIPAA.
• Organizes IRB submissions for multiple trials and tracks submission timelines.
• Processes Protocol Deviations that meet IRB reportable criteria.
• Submits urgent safety notifications to the IRB and coordinates with stakeholders.

Skills

Regulatory knowledge

Medical terminology

Education

Associate’s degree or higher

High school diploma

Job description

Sarah Cannon Research Institute (SCRI) seeks a detail‑oriented Research Regulatory Affairs Specialist to join our expanding oncology programs. You will manage regulatory compliance for sponsors and sites, collaborate with regulatory affairs leads, and help prepare audits while meeting deadlines.

You will maintain regulatory documentation, update informed consent and trial materials, coordinate IRB submissions, and ensure HIPAA and SOP adherence across multiple trials in a fast-paced,