Senior Clinical Research Associate handling site monitoring for clinical trials in Italy. Ensuring protocol compliance and providing leadership in clinical trial management.
Responsibilities
Conduct site monitoring responsibilities for clinical trials
Provide oversight, leadership, and guidance in the management and execution of clinical trials
Ensure protocol compliance, address site questions, and assist with study recruitment
Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
Ensure integrity of CRF data through meticulous and thorough source document review and verification
Requirements
BS/BA from a n 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)
Ability to autonomously manage monitoring activities
Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 (for EU)
Strong command of English, both written and verbal (for US)
Strong command of Local language, both written and verbal, in the country where monitoring activities are performed (for EU)
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