35% - Responsible for meticulous and careful management of regulatory documentation of the Program’s regulatory files; maintains up-to-date files of CVs, medical licensure, note-to-files, conflict of interests, training documentation, laboratory certifications and other documents as needed. Ensures regulatory documents are updated in a timely manner and available for the site monitor at all times.

30% - Build electronic regulatory binders. Alert staff of new documents that are available and ensure documents are filed. Route and track completion of documents requiring signature. Will be responsible for preparing regulatory files for on-site monitoring visits, sponsor audits and regulatory authority audits, as well as reconciling and resolving action items following said on-site visits.

15% - Assist with the following as needed: scheduling and setting up monitoring visits and access for mon...