Senior Clinical Research Associate (CRA) - Italy

A leading CRO is seeking an experienced Freelance Senior Clinical Research Associate fluent in Italian and English to support early-phase oncology studies for a six-month contract.

The role involves managing multiple study sites and ensuring regulatory compliance throughout the study lifecycle.

Location: Milan, Italy
Contract: 6-Month Part-Time Contract (0.3/0.4 FTE)

Key Responsibilities:

• Site Management and Monitoring: Perform pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits for oncology studies.
• Regulatory Compliance: Ensure adherence to ICH-GCP, study protocols, and applicable regulatory requirements.
• Data Integrity and Reporting: Identify, escalate, and resolve site or data quality issues. Ensure accuracy and completeness of essential documents in eTMF/CTMS.
• Collaboration: Work closely with project teams and study sites to ensure study progress, effective communication, and regulatory readiness.
• Study Documentation: Assist in preparing and maintaining essential regulatory documents throughout the study lifecycle.

Required Qualifications:

• Education: Bachelor's degree in biological or human sciences (or equivalent).
• Experience: Minimum of 5 years as a Clinical Research Associate (CRA), with a proven track record in managing early-phase oncology studies.
• Languages: Fluent in Italian and English (written and spoken).
• Skills:
  • In-depth knowledge of ICH-GCP and regulatory requirements.
  • Proficiency in eTMF, CTMS, and Microsoft Office (Outlook, Word, Excel).
  • Strong organizational, communication, and problem-solving skills.

If you have a strong background in early-phase oncology studies and are looking for a freelance contract, we encourage you to apply for this exciting opportunity.