Senior CRA – FSP

• Contribute to the selection of potential investigators
• Support study start-up and regulatory maintenance where required, including site qualification, document preparation, and submissions to EC/IRB and Regulatory Authorities
• Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles
• Confirm completion and documentation of required site staff training, including ICH-GCP training
• Participate in Local Study Team meetings and National Investigators meetings as applicable
• Initiate, monitor, and close study sites in compliance with AstraZeneca procedures
• Share patient recruitment and study site progress information within the Local Study Team
• Drive site performance, identify and resolve study-related issues, and escalate issues appropriately
• Update CTMS and other systems with study-site data within required timelines
• Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction when applicable
• Perform remote and onsite monitoring visits and remote data checks according to the study Monitoring Plan
• Perform Source Data Review, Case Report Form review, and Source Data Verification
• Perform Site Quality Risk Assessments and adapt monitoring intensity during the study
• Ensure timely data query resolution and work with data management to maintain study-data quality
• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups
• Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators
• Follow up on outstanding site actions and ensure timely resolution
• Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready Investigator Site Files
• Prepare for and collaborate on audits and regulatory inspections
• Ensure timely collection and uploading of 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 market feedback on research-related information, sites, investigators, and competing studies
• Collaborate with local MSLs as directed by the LSAD or line manager
• Ensure compliance with AstraZeneca’s Code of Ethics, company policies, procedures, and applicable legislation

• 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 training and compliance knowledge
• Knowledge of AZ Procedural Documents, international guidelines, and relevant local regulations
• Ability to perform monitoring visits, remote data checks, Source Data Review, CRF review, and Source Data Verification
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to use CTMS and other study systems
• Ability to ensure timely reporting of Serious Adverse Events and follow-ups
• Ability to support audits and regulatory inspections
• Ability to ensure compliance with AstraZeneca policies, procedures, legislation, and Code of Ethics

• Fully Remote work arrangement