Regulatory Affairs Specialist, Oncology Trials & Compliance

McKesson; Tennessee; Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Total Rewards

Competitive pay

Job summary

Sarah Cannon Research Institute (SCRI) seeks a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and networks. You will collaborate with regulatory affairs management, the department director, and investigators to ensure audits readiness and timely study progress.

The role emphasizes maintaining FDA and GCP documentation, developing informed consent and protocol updates, IRB submissions, and handling deviations and urgent safety notices across multiple

Qualifications

• Experience in regulatory affairs within clinical research or pharma.
• Familiarity with FDA processes and GCP standards.
• Strong organizational skills and attention to detail.

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
• Ensures regulatory documentation complies with SOPs for format and content
• Maintains critical documentation ensuring regulatory compliance
• Develops informed consent forms and updates protocol, investigator brochure and consent form modifications in line with IRB policies
• Organizes and processes documentation for IRB submission for multiple trials
• Processes Protocol Deviations that meet IRB criteria and submits urgent safety notifications to IRB

Skills

Regulatory affairs

GCP knowledge

FDA knowledge

Education

Associate's degree or higher

Job description

Sarah Cannon Research Institute (SCRI) seeks a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and networks. You will collaborate with regulatory affairs management, the department director, and investigators to ensure audits readiness and timely study progress.

The role emphasizes maintaining FDA and GCP documentation, developing informed consent and protocol updates, IRB submissions, and handling deviations and urgent safety notices across multiple