Senior Clinical Research Associate (Cra) - Italy Bardi

Senior Clinical Research Associate (Cra) - Italy
Bardi
Emilia Romagna, Bardi

Senior Clinical Research Associate (CRA) - ItalyA 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.

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.

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