Clinical Research Regulatory Specialist
Hybrid
Core
Regulatory owner for a clinical trial site ensuring compliance and inspection readiness from activation through closeout.
Role type
Clinical Research Regulatory Specialist
Builds
Regulatory binders, study files, and audit-ready documentation for clinical trials
Domain
Clinical Research / Healthcare
Required skills
IRB management, staff credentialing, delegation of authority, audit readiness, document control, sponsor/CRA communication
Preferred skills
None stated
Technologies
CRIO eReg
Responsibilities
Distribute IRB approvals and amendments; submit continuing reviews and protocol deviations; maintain version control for study documents; complete regulatory onboarding and track staff credentials; maintain regulatory binders for audit readiness; resolve sponsor and CRA action items
Seniority
Individual Contributor
