[Hiring] Clinical Research Associate II @Linical

Role Description

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.

• 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.

Qualifications

• 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%.

Benefits

• Home-based flexibility.
• Opportunity to work on international clinical trials.
• Collaborative and supportive team environment.
• Competitive salary and benefits package.