Senior CRA – FSP

• Monitor assigned clinical study sites independently across all study stages and phases
• Contribute to investigator and site selection
• Support study start-up and regulatory maintenance, including site qualification visits and submissions to EC/IRB and regulatory authorities
• Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles
• Confirm required site training completion and inspection readiness
• Participate in Local Study Team meetings and National Investigators meetings as applicable
• Initiate, monitor, and close study sites
• Share patient recruitment and site performance information with the Local Study Team
• Drive site performance, resolve study-related issues, and escalate issues appropriately
• Update CTMS and other systems with study-site data
• Manage study supplies, drug supplies, and drug accountability
• Perform remote and onsite monitoring visits and remote data checks
• Perform Source Data Review, CRF review, and Source Data Verification
• Conduct Site Quality Risk Assessments and adapt monitoring intensity
• Ensure timely data query resolution and robust study data quality
• Ensure accurate and timely Serious Adverse Event reporting and follow-up
• 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 investigator site files
• Support audits and regulatory inspections
• Collect and upload essential documents to the eTMF and support quality-control checks
• Ensure study documents are ready for final archiving and completion of the local eTMF
• Provide local-market research information 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 LST coordination or document preparation as required
• Ability to travel internationally as required
• Valid driving license
• ICH-GCP knowledge and compliance
• Ability to train, support, and advise investigators and site staff
• Ability to perform clinical study monitoring, including remote and onsite visits
• Experience with CTMS and other study systems
• Knowledge of study supplies, drug accountability, and drug destruction procedures
• Ability to perform Source Data Review, Case Report Form review, and Source Data Verification
• Ability to manage data queries and Serious Adverse Event reporting
• Ability to prepare monitoring visit reports and maintain essential study documentation
• Ability to support audits and regulatory inspections
• Ability to comply with AstraZeneca policies, procedures, legislation, and Code of Ethics

• Full-time employment
• Fully remote work arrangement