Regulatory Affairs Associate - Full Time - Germantown, TN
Core
Coordinate regulatory submissions and approvals for multiple clinical research studies, ensuring compliance with federal regulations.
Role type
Associate-level Regulatory Affairs Specialist (Clinical Research)
Builds
Regulatory documentation and submissions for clinical trials
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
IRB submission management, regulatory documentation maintenance, safety report processing, federal regulations knowledge, GCP familiarity
Preferred skills
Associate's or Bachelor's degree, Research certification
Technologies
Microsoft Word, Excel, Adobe Acrobat
Responsibilities
Coordinate initial and ongoing IRB approvals, maintain site-specific regulatory documents, prepare and submit study documents to IRB/Sponsors/FDA, process safety reports, manage site changes and regulatory updates, perform study closeout activities, assist with training and orientation of new employees
Seniority
Associate, individual contributor
