Associate, Clinical Research

Description:

• 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.