Regulatory Affairs Associate - Full Time - Germantown, TN
About The Position
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. 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.
Requirements
- Two (2) years of regulatory affairs or research experience
- Strong organization and follow-up skills
- Excellent verbal and written communication skills
- Familiarity with Code of Federal Regulations and Good Clinical Practice (GCP)
- Strong problem-solving skills
- Ability to organize and prioritize work assignments
- Ability to manage multiple priorities in a fast-paced environment
- Ability to analyze situations and respond in a timely manner
- Ability to work in multi-functional teams
- Proficiency in computer applications including Word, Excel, Adobe Acrobat, email, and internet research
Nice To Haves
- Associate’s or Bachelor’s degree
- Research certification
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
Benefits
- Comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
