Prolerity Clinical Research

Compliance

• Prepare and submit regulatory documents to IRBs, sponsors, and internal stakeholders, including initial submissions, amendments, continuing reviews, and safety reports
• Maintain and update Investigator Site Files, regulatory binders, and electronic systems such as CRIO, Veeva, and Complion
• Coordinate collection and submission of study start-up documents, including site questionnaires, training logs, CVs, and delegation logs
• Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements
• Liaise with research staff, investigators, sponsors, and IRBs to facilitate regulatory processes
• Keep regulatory files audit-ready and assist with monitoring visits, sponsor audits, and 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
• Perform additional duties as needed to support the research program and organizational needs

Regulatory Specialist