Clinical Research Associate

TL;DR

Clinical Research Associate (Clinical Trials): Managing and monitoring clinical trials to ensure compliance with protocols, ICH-GCP, and regulations with an accent on site initiation, data quality, and patient safety. Focus on source data verification, adverse event reporting, investigational product accountability, and collaboration with project teams and sites.

Company

International biotech CRO founded in 1998 in Italy, providing full-service clinical trial management, medical writing, regulatory activities, and pharmacovigilance for multi-country trials.

What you will do

• Identify, assess, and initiate investigational sites
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
• Perform source data verification and ensure data accuracy and completeness
• Monitor patient recruitment and support sites in meeting targets
• Manage investigational product handling, storage, and accountability
• Maintain study documentation and write monitoring reports
• Collaborate with project teams, sponsors, and site staff; support audits and mentor junior CRAs

Requirements

• Degree in a scientific field
• Minimum 2 years’ CRA or clinical trial monitoring experience
• Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes
• Good English and Microsoft Office skills
• Strong organizational, communication, and problem-solving abilities
• Ability to work independently and in a team

Culture & Benefits

• Competitive salary
• Other benefits and bonuses
• Opportunity to develop professional career in an expanding company