Regulatory Affairs Coordinator — Impact Oncology Trials

Sarah Cannon Research Institute; Tennessee; On-site; USD 55,000 - 75,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials. The Regulatory Coordinator will manage regulatory affairs compliance for industry sponsors and networks, coordinating with regulatory management, site investigators, and QA to ensure audit readiness.

Responsibilities include processing e-signature requests, tracking site signatures, maintaining regulatory documents, and ensuring SOP alignment across sites and networks.

Qualifications

• Associate degree required; a Bachelor’s degree preferred.
• Regulatory experience is preferred.
• Customer service experience is preferred.

Responsibilities

• Process regulatory document signature requests via electronic signature platform.
• Track documents pending site regulatory signatures.
• Provide site-level regulatory support to Clinical Operations teams and investigators.
• Establish and maintain a regulatory document management system.
• Maintain FDA and GCP regulatory documentation for sites, studies, sponsors, and networks.
• Keep physician credentials and other critical regulatory documents up to date.
• Triage site requests for regulatory support and route to the correct pathway.

Skills

Regulatory knowledge

Document management

FDA/GCP compliance

Customer service

Education

Associate degree

Bachelor's degree preferred

Tools

Electronic signature platform

Document management system

Job description

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials. The Regulatory Coordinator will manage regulatory affairs compliance for industry sponsors and networks, coordinating with regulatory management, site investigators, and QA to ensure audit readiness.

Responsibilities include processing e-signature requests, tracking site signatures, maintaining regulatory documents, and ensuring SOP alignment across sites and networks.