Senior Clinical Research Associate – FSP

• Contribute to selection of potential investigators
• Support study start-up and regulatory maintenance, including site qualification, regulatory document preparation, tracking, and submissions where required
• Train, support, and advise investigators and site staff on study-related matters and RbQM principles
• Confirm required site-staff training completion and maintain inspection readiness
• Participate in Local Study Team and National Investigators meetings
• Initiate, monitor, and close study sites
• Drive site performance and resolve or escalate study-related issues
• Update CTMS and other systems with study-site data
• Manage study, drug, and drug-accountability supplies
• Perform remote and onsite monitoring visits, remote data checks, SDR, CRF review, and SDV
• Conduct site quality risk assessments and adapt monitoring intensity
• Ensure timely data-query resolution and collaborate with data management on data quality
• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups
• 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
• Ensure timely collection and uploading of essential documents to the eTMF and support QC checks
• Prepare study documents for final archiving and completion of the local eTMF
• Provide local-market feedback on research information, sites, investigators, and competing studies
• Ensure compliance with AstraZeneca ethics, policies, procedures, and applicable legislation
• 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 travel internationally as required
• Valid driving license
• Ability to perform advanced monitoring and potentially take on LST tasks
• Compliance with AZ Procedural Documents, ICH-GCP, and relevant local regulations