Conduct site monitoring responsibilities for clinical trials giving oversight, leadership, and guidance in managing clinical trials
Ensure compliance and quality of trials while collaborating closely with teams
Review monitoring visit reports and conduct visits as needed
Coordinate with departments for negotiation/issue resolution related to monitoring
Manage study budget and act as referent for the sponsor
Perform visits both remotely and onsite, ensuring documentation of monitoring visits
Prepare accurate and timely monitoring visit reports
Maintain compliance with ICH GCP guidelines, FDA regulations, and SOPs
Facilitate adverse event reporting and manage conflicting priorities
Participate in internal and client/sponsor meetings

US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 years of clinical monitoring experience with 1 year of management experience
EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry
Ability to autonomously manage monitoring activities
US: Permanent authorization to work in the U.S.
EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
EU: Graduation in a scientific health field.
EU: Adequate English

Senior Clinical Research Associate

Key skills