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CLINICAL RESEARCH ASSOCIATE II - ITALY

linical
mid
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Job description

Are you an experienced Clinical Research Associate looking to join a dynamic and growing clinical research organisation? We are seeking a CRA II to manage investigative sites across Italy, ensuring clinical trials are conducted in accordance with study protocols, ICH-GCP, and applicable regulatory requirements. Key Responsibilities • Conduct site qualification, initiation, monitoring, and close-out visits. • Ensure patient safety, data integrity, and protocol compliance. • Perform source data verification and review study documentation. • Manage site relationships and provide ongoing support to investigators and study staff. • Assist with ethics committee and regulatory submissions where required. • Monitor investigational product accountability and site performance. • Maintain Trial Master File (TMF) documentation and support query resolution. • Collaborate with cross-functional study teams to ensure successful trial delivery. About You • Life Sciences degree or equivalent experience, plus recognised CRA training. • Minimum 4 years' clinical research experience. • Minimum 2 years' monitoring experience as a CRA. • Strong knowledge of ICH-GCP, clinical trial regulations, and site management. • Fluent in Italian with a good command of English. • Excellent communication, organisation, and problem-solving skills. • Ability to work independently and manage multiple priorities. • Valid driver's licence and willingness to travel up to 75%. What We Offer • Home-based flexibility. • Opportunity to work on international clinical trials. • Collaborative and supportive team environment. • Competitive salary and benefits package.