Oncology Regulatory Affairs Coordinator - Impactful Trials

Sarah Cannon Research Institute (SCRI); United States; On-site; USD 60,000 - 80,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials across the United States, part of the McKesson family.

As Regulatory Coordinator you will manage regulatory documents, electronic signatures, site start-up, and ongoing regulatory maintenance to ensure FDA and GCP compliance. Work closely with regulatory management, investigators, and clinical operations to meet deadlines and maintain quality standards.

Qualifications

• Regulatory experience preferred.
• Customer service experience preferred.
• Associate or Bachelor’s degree preferred.

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 and managers.
• Establish and maintain a document management system for regulatory files.
• Maintain FDA and GCP regulatory documentation for sites, studies, sponsors, and networks.
• Ensure documentation complies with local SOPs for format and content.
• Keep physician credentials and other critical regulatory documents up to date.
• Triage site requests and identify the correct regulatory pathway.

Skills

Regulatory experience

Customer service

Education

Associate Degree

Bachelor's Degree

Job description

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials across the United States, part of the McKesson family.

As Regulatory Coordinator you will manage regulatory documents, electronic signatures, site start-up, and ongoing regulatory maintenance to ensure FDA and GCP compliance. Work closely with regulatory management, investigators, and clinical operations to meet deadlines and maintain quality standards.