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