Regulatory Affairs Associate - Full Time - Germantown, TN

United States·Germantownmid

Laboratory & Life SciencesRegulatory Affairs Associate

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Quick Summary

Overview

Job Title: Regulatory Affairs Associate About UsAt West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research.

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Laboratory & Life SciencesRegulatory Affairs Associate

Responsibilities

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→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

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Two (2) years of regulatory affairs or research experience

Nice to Have

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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.

What We Offer

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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.