CRA (Level II)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8g1p5x

Work ScheduleStandard (Mon-Fri)

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Environmental ConditionsOffice
Job DescriptionWe're looking for a Clinical Research Associate II (CRA II) to join our growing Clinical Operations team in Italy . If you're passionate about clinical research, enjoy building strong site relationships, and want to contribute to studies that make a real difference for patients worldwide, we'd love to hear from you.
What You'll DoAs a CRA II, you'll be responsible for monitoring clinical trial sites and ensuring studies are conducted in compliance with protocols, ICH-GCP guidelines, applicable regulations, and company SOPs.
Your responsibilities will include:
- Conducting on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach.
- Ensuring subject safety, data integrity, and protocol compliance.
- Performing Source Data Verification (SDV), Source Data Review (SDR), and CRF review.




- Assessing investigational product accountability through inventory and documentation reviews.
- Identifying site issues, performing root cause analysis, and implementing corrective and preventive actions (CAPA).
- Preparing high-quality monitoring reports and ensuring timely follow-up of action items.
- Supporting site initiation, routine monitoring, and close-out visits.
- Reviewing essential documents to ensure compliance with ICH-GCP and regulatory requirements.
- Maintaining study documentation and updating clinical trial management systems (CTMS).
- Building collaborative relationships with investigators, site staff, sponsors, and cross-functional project teams.
- Supporting audit and inspection readiness throughout the study lifecycle.
- Participating in investigator meetings and contributing to process improvement initiatives.
- Completing administrative activities, including expense reports and timesheets, accurately and on ti

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8g1p5x