Clinical Research Associate Car-T
Pubblicato il 31-07-2026 - Altro in Milano
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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