Job Summary Senior Chief Research Associate (Sr CRA) based in Italy, responsible for independent site monitoring, oversight, and management of clinical trials to ensure compliance with protocols, GCP, and sponsor requirements. Works closely with US and EU monitoring teams and project managers to support protocol adherence, site recruitment, training, and study progress. Key Responsibilities Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Review monitoring visit reports, conduct co‐monitoring and evaluation visits, and ensure timely investigator site visits. Coordinate with cross‐functional departments to negotiate/resolve monitoring related issues. Assist in development of study‐specific monitoring plans and training presentations. Set up/collect site‐specific ethics documents and negotiate site contracts. Provide monthly billing information to finance team and manage study budget for stand‐alone projects. Perform qualification, initiation, interim,

and close‐out visits both remotely and onsite, ensuring proper documentation. Prepare accurate monitoring visit reports documenting site problems, resolutions, actions, protocol deviations, progress, and enrollment. Ensure integrity of CRF data through meticulous source document review and verification. Perform quality control and verification of documents collected at sites for e TMF/TMF. Conduct investigational product accountability and review site regulatory binder for required documents. Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual, and respond to sponsor requests. Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs. Collaborate with in‐house CRAs/CTC and data management to resolve queries on discrepant data. Proactively identify site issues and develop problem‐solving strategies. Conduct audit preparation at study sites as needed

Sr clinical research associate

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