Regulatory Coordinator
Core
Oversee clinical research regulatory requirements and manage clinical trials from submission to closure, ensuring compliance with federal, state, and local guidelines.
Role type
Senior clinical research regulatory coordinator
Builds
Clinical trial regulatory submissions and compliance frameworks
Domain
Healthcare / Clinical Research
Required skills
Clinical trial administration, FDA guidelines, regulatory compliance, protocol development, IND/IDE application preparation, consent document creation, stakeholder liaison, process improvement, policy development, database management
Preferred skills
SoCRA certification, mentorship of clinical research staff, independent decision-making
Technologies
Microsoft Office, various database applications
Responsibilities
Consult on regulatory documents and processes for clinical trials; serve as regulatory subject matter expert; develop and revise regulatory policies; coordinate IND/IDE submissions; interpret protocols and create consent documents; liaise with sponsors, investigators, and IRBs; maintain study-specific regulatory binders.
Seniority
Mid-Senior level, independent contributor with mentorship responsibilities
