Regulatory Affairs Coordinator

Sarah Cannon Research Institute • Work at Home - Tennessee, USA (WTNA), TN

2d

About The Position

As the Regulatory Coordinator you are responsible for managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. In this position you will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.

Requirements

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

Responsibilities

• Process regulatory document signature request through 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 Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
• Maintain updated physician credentials for network participants and other critical documentation ensuring compliance
• Triage site requests for regulatory support and identifies correct pathway for issue resolution

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being
• Competitive compensation package
• Annual bonus or long-term incentive opportunities may be offered

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree