Regulatory Affairs Associate I — IRB & Compliance Focus

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

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.