Clinical Research Associate CAR-T
Pubblicato il 03-08-2026 - Experteer Italy in Lombardia
Experteer Overview
As a Clinical Research Associate, you will oversee CAR-T studies at allocated sites in Italy, acting as the primary site contact and ensuring timely, compliant study delivery. You’ll work with local study teams to drive site performance, quality, and data integrity in alignment with ICH-GCP and AZ procedures. The role blends monitoring, site qualification, training, and risk‑based quality management to advance innovative therapies. You will contribute to cross‑functional study teams and help ensure sites are inspection‑ready, ultimately supporting patient outcomes.
Retribuzione / Benefits
- Coordinate site qualification visits and start‑up documentation
- Monitor site performance and ensure adherence to study commitments
- Train and support investigators and site staff on study‑related matters
- Manage monitoring visits (onsite and remote) and data checks per Monitoring Plan
- Conduct SDR/CRF review and SDV
- Perform Site Quality Risk Assessments and adjust monitoring intensity
- Ensure timely SAEs reporting and follow‑ups
- Maintain inspection readiness and support audits/regulatory inspections
- Collaborate with Local Study Team and LSM/CQM on issues and extensions
- Oversee study drug handling, accountability, and destruction as applicable
- Ensure documentation is archived and available for finalization
- Engage with external service providers when needed
- Support patient recruitment data sharing and site progress updates
- Ensure compliance with ICH-GCP, AZ SOPs, local regulations
- Maintain relationships with investigators and account management aligned with company values
Responsabilità
- Scientific Degree equivalent degree
- Experience in management of CAR-T Cell Therapy studies
- Excellent knowledge of ICH-GCP; basic GMP/GDP knowledge
- Good knowledge of local regulations
- Strong medical knowledge and ability to learn AZ Therapeutic Areas
- Understanding of drug development process and clinical study management
- Strong attention to detail and communication skills
- Good collaboration and interpersonal skills
- Good negotiation and problem solving skills
- Ability to travel nationally/internationally; valid driving license
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