Prolerity Clinical Research

Compliance

• Assist in preparing and submitting regulatory documents to IRBs, sponsors, and internal stakeholders including initial submissions, amendments, continuing reviews, and safety reports
• Maintain and update Investigator Site Files (ISFs), regulatory binders, and electronic systems to ensure documents are current and properly filed
• Help coordinate collection and submission of start-up documents such as site questionnaires, training logs, CVs, and delegation logs
• Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements
• Serve as a liaison between research staff, investigators, sponsors, and IRBs to facilitate timely and accurate regulatory processes
• Keep regulatory files audit-ready and assist with preparation and support during monitoring visits, sponsor audits, or inspections
• Attend regulatory meetings, take minutes as needed, and provide updates on document status and submission timelines
• Track expiration dates for approvals, licenses, and other time-sensitive documents; assist with regulatory logs and tracking tools

Regulatory Specialist