Regulatory Affairs Associate - Full Time - Germantown, TN

West Cancer Center & Research Institute; Germantown (TN); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Comprehensive benefits package

No nights, weekends, or holidays

Job summary

West Cancer Center & Research Institute is seeking a Regulatory Affairs Associate I to coordinate regulatory submissions and IRB activities for multiple studies. You will manage regulatory documentation, safety reports, and maintain compliance with federal regulations while supporting ongoing research efforts.

The role emphasizes collaboration with Sponsors, CROs, investigators, and research staff to ensure timely approvals and accurate study records.

Qualifications

• Two (2) years of regulatory affairs or research experience.
• Associate’s or Bachelor’s degree required (preferred).
• Familiarity with CFR and Good Clinical Practice (GCP).
• Research certification preferred.

Responsibilities

• Coordinate IRB approvals for assigned studies.
• Maintain regulatory documents for multiple studies.
• Submit study documents to IRB, Sponsors, and FDA as appropriate.
• Support safety reporting and regulatory compliance.
• Prepare study binders and maintain regulatory correspondence.

Skills

Organization

Verbal & written communication

Regulatory knowledge

Multi-tasking

Education

Associate’s or Bachelor’s degree

Research certification (preferred)

Tools

Word

Excel

Adobe Acrobat

Job description

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

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

Preferred

• 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

Why West Cancer Center is a Great Place to Work

• 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.