Regulatory Affairs Associate

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, and/or FDA as appropriate
• Maintain study binders with required documents and correspondence
• Meet study deadlines and coordinate with staff for subject information needed for updates and re-approvals
• Perform study closeout activities as appropriate
• Maintain essential regulatory documents
• Obtain IRB approval for updated study documents (protocol amendments, informed consent forms, Investigator Brochures, patient materials, etc.)
• Manage site changes including regulatory updates and documentation
• Process safety reports
• Maintain working knowledge of federal regulations
• Participate in Sponsor/CRO monitoring visits and audits
• Assist with report compilation, quality control of regulatory documents, and other assigned tasks
• Maintain professionalism and confidentiality in all interactions
• Assist with training and orientation of new employees
• Interface with external partners including sites, sponsors, CROs, IRBs, and FDA
• Perform all other duties as assigned

Qualifications

Education & Experience
Required:

• Two (2) years of regulatory affairs or research experience

Preferred:

• Associate’s or Bachelor’s degree