Regulatory Affairs Coordinator — Oncology Clinical Trials

Sarah Cannon Research Institute; United States; Remote; USD 55,000 - 82,000; Full time

Benefits offered by this job

Total Rewards package

Annual bonus opportunities

Job summary

Sarah Cannon Research Institute (SCRI) seeks a Regulatory Coordinator to manage regulatory affairs compliance for industry sponsors and sites. You will collaborate with regulatory affairs leadership and investigators to ensure timely audits and maintain compliant documentation.

Primary duties include signature processing, tracking, and supporting site regulatory activities within a network. The role requires coordinating with FDA/GCP standards and maintaining credentialing for network

Qualifications

• Regulatory experience is preferred
• Customer service experience is preferred
• Ability to maintain and manage regulatory documentation and files

Responsibilities

• Process regulatory document signature requests through an electronic signature platform
• Track documents pending site regulatory signatures
• Provide site-level regulatory support to Clinical Operations’ sites and managers
• Establish and maintain a document management system for regulatory files
• Maintain FDA and GCP documentation for sites, studies, sponsors, and networks
• Triage site requests for regulatory support and identify the correct path for issue resolution

Skills

Regulatory affairs

Documentation management

Customer service

Education

Associate Degree

Bachelor’s Degree preferred

Job description

Sarah Cannon Research Institute (SCRI) seeks a Regulatory Coordinator to manage regulatory affairs compliance for industry sponsors and sites. You will collaborate with regulatory affairs leadership and investigators to ensure timely audits and maintain compliant documentation.

Primary duties include signature processing, tracking, and supporting site regulatory activities within a network. The role requires coordinating with FDA/GCP standards and maintaining credentialing for network