Clinical Research Associate II
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- Italy at Linical in Milano, LOM, IT. This Full time on site position offers great opportunities for career growth. 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. #J-18808-Ljbffr
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