Short Description
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. |
Experience Required
Must have at least 3-5 years of related experience.
Education Requirements
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field