CRA / SENIOR CRA - Homebased (Italy) Temporary (1 year with possibility to be extended) TFS Health Science is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Join Our Team as a Clinical Research Associate home-based in Italy About This Role The Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions (SRS) within TFS Health Science and will function operationally as a member of a Project Team and is responsible for the initiation, on–site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements. Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy Verify proper management and accountability of Investigational Product. Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner. verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements. Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
Order, ship, and reconcile clinical investigat
📌 Senior Clinical Research Associate homebased (Italia)
🏢 Tfs Healthscience
📍 Italia
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