Clinical Research Associate

Astrazeneca

Introduction to role: As a Clinical Research Associate (CRA) within AstraZeneca’s Oncology Cell Therapy Clinical Operations, you will have local responsibility for the delivery of clinical studies at assigned sites and serve as the primary point of contact for investigators and site staff. You will work closely with Local Study Teams and the Local Study Associate Director (LSAD) to ensure timely, high-quality execution in alignment with ICH-GCP, local regulations, and AstraZeneca procedural documents. Leveraging risk-based quality management principles, you will prepare, initiate, monitor, and close sites, ensuring inspection readiness and robust data quality across our innovative oncology cell therapy portfolio. Accountabilities: Site identification and start-up : Contribute to investigator/site selection. In applicable countries, lead start-up and regulatory maintenance, including qualification visits, dossier preparation, submissions to EC/IRB and Regulatory Authorities, and tracking essential documents. Training and inspection readiness : Train and advise investigators and site staff on protocol and RbQM. Confirm and document mandatory trainings (including ICH-GCP) and maintain inspection-ready site files at all times. Study conduct and performance : Initiate, monitor (onsite/remote), and close sites per Monitoring Plan and SOPs; share recruitment and site performance insights with Local Study Teams; proactively identify, resolve, and escalate study issues. Monitoring and data quality : Perform SDR, SDV, and CRF review; adapt monitoring intensity via regular Site Quality Risk Assessments; ensure timely query resolution and collaborate with data management for high-quality data. Safety and compliance : Secure accurate and timely reporting of SAEs and follow-ups; ensure compliance with AZ Code of Ethics, SOPs, ICH-GCP, data privacy requirements, and applicable legislation. Systems and documentation : Update CTMS and other systems per timelines; manage study supplies and drug accountability (including destruction preparation); prepare monitoring visit reports and follow-up letters; collect/upload essential documents to eTMF and support QC checks; ensure documentation is complete for archiving. Audit/inspection support : Prepare for and collaborate on audit and regulatory inspection activities with LSAD and Clinical Quality. Cross-functional collaboration : Work with LSADs, local medical teams (e.g., MSLs), and global study teams/vendors as directed; provide market and site intelligence relevant to oncology cell therapy studies. Essential Skills/Experience: Education : Bachelor’s degree in a related discipline (preferably life sciences) or equivalent qualification. Guidelines and regulations : Excellent knowledge of ICH-GCP; good knowledge of relevant local regulations; basic knowledge of GMP/GDP. Clinical operations : Solid understanding of clinical study management, including monitoring (onsite/remote), study drug handling, and data management; familiarity with risk-based monitoring and remote monitoring practices. Technical and analytical : Strong attention to detail; good analytical and problem-solving skills; ability to use e-enabled systems (CTMS, eTMF, EDC) and adapt to new technologies. Communication and collaboration : Good written and verbal communication; effective interpersonal and negotiation skills; ability to work with remote collaborators and in cross-functional teams. Delivery focus : Demonstrated ability to prioritize and manage multiple tasks with conflicting deadlines; proactive issue identification and resolution; ability to travel nationally/internationally as required. Professional conduct : Commitment to inspection readiness, patient safety reporting, data privacy, and adherence to AZ Code of Ethics and SHE requirements. Desirable Skills/Experience: Therapeutic area exposure : Medical knowledge and learning agility in oncology; interest or experience in cell therapy or advanced therapies. Process excell