Westcancercenter
Regulatory Affairs Associate - Full Time - Germantown, TN
Germantown, TN · Full-time
Sponsorship not specifiedDetected 16 days ago
GCPComplianceExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationProblem SolvingGxPRegulatory Affairs
About the role
- Our team fosters collaboration, innovation, and professional growth, ensuring that every role contributes to making a difference in patients' lives.
- 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.
- Join Us If you are detail-oriented and passionate about supporting clinical research and regulatory compliance, we invite you to join West Cancer Center as a Regulatory Affairs Associate I and contribute to advancing innovative cancer care.
Responsibilities
- 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
- 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
- Maintain working knowledge of federal regulations
- Assist with report compilation, quality control of regulatory documents, and other assigned tasks
- Maintain professionalism and confidentiality in all interactions
Nice to have
- Associate's or Bachelor's degree
- Research certification
- 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 analyze situations and respond in a timely manner
Company info
- Coordinate initial and ongoing IRB approvals for assigned studies
- Maintain study binders with required documents and correspondence
- Meet study deadlines and coordinate with staff for subject information needed for updates and re-approvals
- Process safety reports
- Participate in Sponsor/CRO monitoring visits and audits
- At West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research.
- 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.
- Assist with training and orientation of new employees
- Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
Visa & Work Authorization
- Participate in Sponsor/CRO monitoring visits and audits
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