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How You'll Make an Impact:
- Provide regulatory advice, lead, execute and deliver regulatory project work.
- Support regulatory compliance activities for U.S. clinical research sites, ensuring adherence to FDA, OHRP and global regulatory standards.
- Coordinate and perform IRB site level submissions and maintenance of approvals.
The Expertise Required:
- Minimum of 4 years of experience in operational regulatory affairs within a research site, CRO, or pharmaceutical industry.
- Strong understanding of U.S. regulations and ICH GCP guidelines as they relate to site operations.
- Excellent knowledge of site-level regulatory requirements for IRB submissions and ongoing compliance.
How We Work Together:
- Remote within the United States or Canada with 100% remote work environment.
- Less than 10% travel requirements.
- Collaborative environment with cross-functional teams including Quality and Clinical Operations.
Care Access
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.