Regulatory Affairs Associate - Full Time - Germantown, TN

The role

The Regulatory Affairs Associate I coordinates regulatory submissions and approvals for multiple studies. This role manages IRB submissions, maintains regulatory documentation, and ensures compliance with federal regulations.

What you will do

• Coordinate initial and ongoing IRB approvals for assigned studies
• Maintain regulatory responsibility for multiple studies
• Collect and maintain site-specific regulatory documents
• Prepare and submit study documents to IRB, Sponsors, and/or FDA
• Maintain study binders with required documents and correspondence
• Meet study deadlines and coordinate with staff for subject information
• Perform study closeout activities
• Obtain IRB approval for updated study documents
• Manage site changes including regulatory updates and documentation
• Process safety reports

Required qualifications

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

Nice to have

• Associate’s or Bachelor’s degree
• Research certification

Benefits

• Comprehensive benefits package

About the company

West Cancer Center is dedicated to providing compassionate, patient-centered care while advancing groundbreaking research. The team fosters collaboration, innovation, and professional growth.