Senior Clinical Research Associate – FSP

• Take local responsibility for delivery of studies at allocated sites
• Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study commitments
• Act as the main contact with study sites
• Prepare, initiate, monitor, and close assigned clinical study sites
• Contribute to investigator selection
• Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and Regulatory Authority submissions where required
• Train, support, and advise investigators and site staff on study-related matters and RbQM principles
• Confirm site staff training completion and maintain inspection readiness
• Participate in Local Study Team and, where applicable, National Investigators meetings
• Drive site performance, identify and resolve study issues, and escalate appropriately
• Update CTMS and other systems with site data
• Manage ISF, drug supplies, drug accountability, and drug destruction where applicable
• Perform remote and onsite monitoring visits according to the Monitoring Plan
• Perform SDR, CRF review, SDV, site quality risk assessments, and data query resolution
• Work with data management to ensure study data quality
• Report Serious Adverse Events and follow-ups accurately and promptly
• Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready ISFs
• Support audits and regulatory inspections
• Collect and upload essential documents to the eTMF and support QC checks
• Ensure study documents are ready for final archiving and local eTMF completion
• Provide research-related market feedback on sites, investigators, and competing studies
• Collaborate with local MSLs as directed

• Minimum 3–5 years' experience as a monitor
• Ability to work independently and monitor all stages of a study across different phases
• Special therapeutic expertise in oncology
• Ability to take on LST tasks and support the LST in coordination or document preparation as required
• Ability to travel internationally as required
• Valid driving license
• Completion and documentation of required training, including ICH-GCP training, before and throughout the study
• Knowledge of ICH-GCP, AZ Procedural Documents, international guidelines, and relevant local regulations
• Ability to perform remote and onsite monitoring visits, remote data checks, SDR, CRF review, and SDV
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to ensure timely reporting of Serious Adverse Events and follow-ups
• Ability to use CTMS and other study systems
• Ability to comply with AstraZeneca policies, Code of Ethics, legislation, and SHE requirements

• Fully remote work arrangement
• Full-time employment
• Standard Monday–Friday work schedule