Regulatory Affairs Associate Germantown, TN

Regulatory Affairs Associate
- Full Time
- Germantown, TN

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.

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

Two (2) years of regulatory affairs or research experience

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 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

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.

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.