Regulatory Affairs Associate - Full Time - Germantown, TN at West Cancer Center in Germantown, TN

Job description

• 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.

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

Requirements

• Education & Experience
• Two (2) years of regulatory affairs or research experience
• Associate’s or Bachelor’s degree
• Research certification
• Skills & Abilities
• 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

Skills

Required

• Strong organization and follow-up skills
• Strong problem-solving skills

Benefits

• Meaningful 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.