Regulatory Affairs Associate - Full Time - Germantown, TN
Job Title: Regulatory Affairs Associate
About Us
At West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research. Our team fosters collaboration, innovation, and professional growth, ensuring that every role contributes to making a difference in patients’ lives. Join us in our mission to provide comprehensive support to those navigating the challenges of cancer treatment.
Position Overview
The Regulatory Affairs Associate I works closely with Sponsors, CROs, investigators, and research staff to coordinate regulatory submissions and approvals for multiple studies. This role is responsible for managing Institutional Review Board (IRB) submissions, maintaining regulatory documentation, processing safety reports, and ensuring compliance with federal regulations while supporting ongoing research activities.
Key Responsibilities
- Coordinate initial and ongoing IRB approvals for assigned studies
- Maintain regulatory responsibility for multiple studies
- Collect and maintain site-specific regulatory documents (CVs, licenses, lab certifications, FDA Form 1572, delegation logs, etc.)
- Prepare and submit study documents to IRB, Sponsors,
