Regulatory Affairs Associate - Full Time - Germantown, TN

Regulatory Affairs Associate - Full Time - Germantown, TNRegulatory Affairs AssociateAt 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.Coordinate initial and ongoing IRB approvals for assigned studiesMaintain regulatory responsibility for multiple studiesCollect 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 appropriateMaintain study binders with required documents and correspondenceMeet study deadlines and coordinate with staff for subject information needed for updates and re-approvalsPerform study closeout activities as appropriateMaintain essential regulatory documentsObtain IRB approval for updated study documents (protocol amendments, informed consent forms, Investigator Brochures, patient materials, etc.)Manage site changes including regulatory updates and documentationProcess safety reportsMaintain working knowledge of federal regulationsParticipate in Sponsor/CRO monitoring visits and auditsAssist with report compilation, quality control of regulatory documents, and other assigned tasksMaintain professionalism and confidentiality in all interactionsAssist with training and orientation of new employeesInterface with external partners including sites, sponsors, CROs, IRBs, and FDAPerform all other duties as assignedTwo (2) years of regulatory affairs or research experienceAssociate's or Bachelor's degreeResearch certificationStrong organization and follow-up skillsExcellent verbal and written communication skillsFamiliarity with Code of Federal Regulations and Good Clinical Practice (GCP)Strong problem-solving skillsAbility to organize and prioritize work assignmentsAbility to manage multiple priorities in a fast-paced environmentAbility to analyze situations and respond in a timely mannerAbility to work in multi-functional teamsProficiency in computer applications including Word, Excel, Adobe Acrobat, email, and internet researchMeaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.No nights, weekends, or holidays. Comprehensive benefits package.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.