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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.