Conduct site monitoring responsibilities for clinical trials
Provide oversight, leadership, and guidance in the management and execution of clinical trials
Ensure compliance and quality in clinical trials
Review monitoring visit reports and conduct co-monitoring and evaluation visits
Ensure appropriate and timely investigator site visits
Coordinates with cross-functional departments
Assist in development of study-specific Monitoring Plans and training presentations
Manage study budgets and act as referent for the sponsor for monitoring stand-alone projects
Prepare accurate and timely monitoring visit reports
Ensure integrity of CRF data through source document review and verification
Conduct quality control and verification of documents collected at sites

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 (for EU)
Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 (for EU)
Graduation in a scientific health field (for EU)
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 (for EU)

Senior Clinical Research Associate

Key skills