Regulatory Affairs Coordinator — Clinical Trials

McKesson; Tennessee; Hybrid; USD 60,000 - 75,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Regulatory Coordinator to manage regulatory affairs and ensure compliance for sponsors and sites. You will work with regulatory management, department directors, and investigators to meet deadlines and audits.

The role involves maintaining FDA/GCP documentation, implementing a document management system, and supporting site start-up and ongoing regulatory maintenance across networks.

Qualifications

• Associate Degree, preferably a Bachelor’s Degree.
• Regulatory experience preferred.
• Customer service experience preferred.

Responsibilities

• Process regulatory document signature requests via an electronic signature platform.
• Track documents pending site regulatory signatures.
• Provide site-level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start‑up and ongoing regulatory maintenance.
• Establish and maintain a document management system for regulatory paper and electronic files.
• Maintain FDA and Good Clinical Practice (GCP) regulatory documentation for individual sites, studies, sponsors and/or networks.
• Ensure all regulatory documentation is compliant with local SOPs for format and content.
• Maintain updated physician credentials for network participants and other critical documentation ensuring compliance.
• Triage site requests for regulatory support and identify correct pathway for issue resolution.

Skills

Regulatory experience

Customer service experience

Education

Associate Degree, preferably a Bachelor’s Degree

Job description

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Regulatory Coordinator to manage regulatory affairs and ensure compliance for sponsors and sites. You will work with regulatory management, department directors, and investigators to meet deadlines and audits.

The role involves maintaining FDA/GCP documentation, implementing a document management system, and supporting site start-up and ongoing regulatory maintenance across networks.