Conduct site monitoring responsibilities for clinical trials
Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with site training
Review monitoring visit reports, conducts co-monitoring and evaluation visits as needed
Ensures appropriate and timely investigator site visits
Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
Assists in development of study-specific Monitoring Plans and training presentations as required
Assists in setup/collection of site-specific ethics documents and site contract negotiation as required
Provides monthly billing information to finance team as required
Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.

BS/BA from an undergraduate program (life sciences or related discipline preferred)
3 years of experience in the pharmaceutical/biotechnology/CRO industry
2 years of clinical monitoring experience with 1 year of management experience
Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities
Strong command of English, both written and verbal
Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
Graduation in a scientific health field.
Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
Permanent authorization to work in the U.S.

Senior Clinical Research Associate

Key skills