Work with sponsors during the study start-up process to prepare the regulatory documents and maintain the studies' regulatory binders throughout duration of study through close out including version control.

Work with the Institutional Review Board to submit initial study applications, amendments, continuing reviews, adverse event reports and other submissions.

Provide regular updates to the Regulatory and Operations team members on where studies are in the review/start-up process, monitoring outcomes, and close out preparation.

Maintain the delegation of authority logs and regulatory documentation for each study and ensure study staff training on each protocol.

Work with sponsors to set up site initiation visits, monitoring visits and study close-out visits and prepare post-visit documents.

Maintains tracking for all protocol related paperwork and collects documents from sponsors for protocol submission and maintenance.

Coordinates FDA submissions and prepares for all research audits.