Vacancy caducado!
- 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
- Bachelor degree
- +5 of experience with European Medical Device Regulations and product recertification/remediation.
Vacancy caducado!