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
Regulatory Affairs Associate I
Builds
Regulatory documentation and submissions for clinical research studies
Domain
Clinical research / Healthcare
Deliverable
client delivery
Required skills
IRB submission coordination, regulatory document management, safety report processing, federal regulations knowledge, GCP familiarity, site change management, audit support
Preferred skills
Associate's or Bachelor's degree, Research certification
Technologies
Word, Excel, Adobe Acrobat
Responsibilities
Coordinate initial and ongoing IRB approvals, maintain regulatory responsibility for multiple studies, collect and maintain site-specific regulatory documents, prepare and submit study documents to IRB/Sponsors/FDA, maintain study binders, process safety reports, perform study closeout activities, obtain IRB approval for updated study documents, manage site changes, participate in Sponsor/CRO monitoring visits and audits
Seniority
Entry-level to Mid-level, hands-on IC