Regulatory Assistant

Regulatory Support & Study Administration:

• Assist Regulatory Coordinators with the regulatory startup, maintenance, continuing review, amendments, and study closeout activities.
• Support study startup and activation activities by gathering and preparing required regulatory documents and site information.
• Assist with processing regulatory correspondence and maintaining regulatory documentation.

Institutional & External Reviews:

• Support maintenance of documentation related to safety report review and regulatory reporting requirements.
• Respond to routine requests for information from Regulatory Coordinators, study teams and institutional offices.
• Escalate complex regulatory issues and contingencies to Regulatory Coordinators or management.

Documentation & Systems:

• Maintain study regulatory files and binders, ensuring documentation is complete, current, and audit-ready.
• Ensure required investigator and study staff credentialing are maintained and filed appropriately.
• Manage protocol-specific training records and study personnel delegation documentation.

Compliance, Quality & Monitoring Support:

• Assist in preparing materials for monitor visits, audits, and regulatory inspections.
• Assist Regulatory Coordinators with tracking and documenting corrective actions associated with routine monitoring findings.
• Report potential compliance concerns to Regulatory Coordinators and management.