Write informed consents and edit them for sites and check for FDA requirements
Help negotiate the clinical trial agreement if needed with legal
Understand the budget and assist the budget group with negotiation if needed
Help prepare and write study start-up documents: slides for training sites and field clinical specialists, clinical trial project plan, Operations Manual, patient materials, writing CRFs and instructions etc.
Assist the site with IRB approval and renewals
Has performed site qualification visits
Site compliance deviations, data correction forms, writing corrective action plans, excellent knowledge of the regulations
Written adverse event narratives
Committee Management - assist with the DSMB activities in the collection of source for adverse events and the de-identification of source, understanding if you have the correct source per the adverse event
Site initiation visits and training
+5 of experience with European Medical Device Regulations and product recertification/remediation.