Regulatory Affairs Coordinator
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. You will process regulatory document signature request through an electronic signature platform You will track documents pending site regulatory signatures You will 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 You will establish and maintain a document management system for regulatory paper and electronic files You will maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. You will ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content You will maintain updated physician credentials for network participants and other critical documentation ensuring compliance You will triage site requests for regulatory support and identifies correct pathway for issue resolution
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
