CRA (Level II)
RemoteMilan, Lombardy, Italy or Italy
Job Summary
Conduct on-site and remote monitoring visits using a Risk-Based Monitoring approach to ensure studies comply with protocols, ICH-GCP guidelines, and company SOPs. Perform Source Data Verification, Source Data Review, and CRF analysis while assessing investigational product accountability. Identify site issues, execute root cause analysis, and implement corrective and preventive actions. Prepare high-quality monitoring reports, maintain study documentation, and support audit readiness across the study lifecycle. Build collaborative relationships with investigators and cross-functional teams while completing administrative tasks such as expense reports and timesheets. Requires a Master's degree, 1+ years of clinical monitoring experience, fluency in Italian and English, and frequent travel across Italy.
Required Qualifications
- Master's degree in Life Sciences or an equivalent scientific qualification
- Approximately 1+ year of clinical monitoring experience as a Clinical Research Associate or equivalent
- Good knowledge of ICH-GCP guidelines and applicable clinical research regulations
- Valid driver's license
- Fluency in Italian and English, both written and spoken
- Strong clinical monitoring experience
- Solid understanding of clinical trial processes and medical terminology
- Knowledge of Risk-Based Monitoring principles
- Excellent analytical thinking and problem-solving skills
- Ability to identify root causes and proactively resolve issues
- Strong communication and relationship-building skills
- High attention to detail and commitment to quality
- Excellent planning, organization, and time management abilities
- Customer-focused mindset with the ability to collaborate across diverse teams
- Flexibility and adaptability in a dynamic environment
- Proficiency in Microsoft Office and clinical systems
- Frequent travel to investigator sites across Italy
- Regular driving
- Occasional overnight stays
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