Responsible for Clinical Research Associate and investigator site support for assigned sites: Clinical Trial Site Activation & Conduct.
Build and maintain a deep understanding of global / local regulatory requirements; particularly to ensure effective Site Activation.
Supports and/or coordinates central Investigator Review Board (IRB) submissions
Support local IRB workflow from submission through approval inc query management
Work with Sites to complete critical information for site activation; such as Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information etc.
Follow-up with Sites on status of study documentation and identify/resolve issues within required timeframes; agree and develop corrective and preventative actions to prevent recurrences
Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 for internal approval within required timelines. Communicate site approvals.
Update, with Sites, ongoing study documents e.g. protocol amendments and FDA 1572 revisions
Support CRA with patient recruitment, study progress and metrics updates
Accurately update and maintain clinical systems e.g. Study Registry
Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file
Act as a point contact for the study team for designated site communications; coordinates with CRA and other study team roles.
Understands basic medical terminology & GCP requirements
Detail orientated approach to document review, adherence to SOPs, metrics, etc.
Self-organized - tasks, time and priorities with ability to multi-task