Clinical Research Associate

Responsibilities

• Perform site qualification, initiation, monitoring, and closure of assigned sites in clinical studies
• Ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations
• Train, support, and advise investigators and site staff on study-related matters
• Manage study supplies, drug accountability, and drug destruction at study sites
• Conduct remote and onsite monitoring visits and source data verification (SDV)
• Perform regular Site Quality Risk Assessments and manage data query resolution
• Ensure accurate and timely reporting of Serious Adverse Events (SAEs)
• Prepare and finalize monitoring visit reports and follow-up letters
• Collaborate with local MSLs and participate in Local Study Team meetings

Requirements

• Scientific degree
• Experience managing CAR-T Cell Therapy studies
• Excellent knowledge of ICH-GCP guidelines
• Basic knowledge of GMP/GDP and local regulations
• Understanding of drug development and clinical study management
• Valid driving license
• Ability to travel nationally and internationally

Preferred Qualifications

• Project management skills (scope, budget, timeline, resource management)
• Hands-on experience in Clinical Research/Operations within the pharmaceutical industry
• Knowledge of R&D ways of working
• Experience working with External Service Providers

Benefits

• Annual target bonus
• Wellbeing benefits (welfare, insurance, psychological support)
• Participation Bonus