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TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Freelance Senior Clinical Research Associate (0.4 FTE) - home based in Italy.
About this role As part of our Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Freelance Senior Clinical Research Associate is part of Clinical Development Services (CDS) within TFS HealthScience , will function operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and regulatory requirements. The Freelance Senior Clinical Research Associate will provide Unmasked Clinical Research Associate support for assigned clinical studies,
including management of investigational product accountability, oversight of unblinded site activities, and monitoring of protocol compliance in accordance with study requirements and applicable regulations. The Freelance Senior Clinical Research Associate will collaborate with study teams, investigative sites and sponsors to ensure timely execution of study deliverables while maintaining the integrity of study blinding and data quality.
Key Responsibilities: 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 o
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