Clinical Research Associate II - Italy

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.