Regulatory Affairs Associate - Full Time - Germantown, TN

West Cancer Center•Germantown, TN

1d•Onsite

About The Position

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.

Requirements

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

Associate's or Bachelor's degree
Research certification

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