The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials
Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
Ensures appropriate and timely investigator site visits
Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests

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 and 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.
US: Strong command of English, both written and verbal
EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed

Senior Clinical Research Associate

Key skills