Senior CRA – FSP

• Contribute to the selection of potential investigators
• Support study start-up and regulatory maintenance, including site qualification visits and submission of documents to EC/IRB and Regulatory Authorities where required
• Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles
• Confirm required site-staff training completion and maintain inspection readiness
• Participate in Local Study Team meetings and National Investigators meetings as applicable
• Initiate, monitor, and close study sites in compliance with procedural documents
• Share patient recruitment and site progress information within the Local Study Team
• Drive site performance and resolve or escalate study-related issues
• 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 SDR, CRF review, and SDV according to the Monitoring Plan
• Conduct site quality risk assessments and adapt monitoring intensity
• Ensure timely data-query resolution and collaborate with data management on study-data quality
• Ensure accurate and timely reporting and follow-up of Serious Adverse Events
• Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate systematic or serious quality, privacy, compliance, and ICH-GCP issues
• Assist sites with 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 eTMF completion
• Provide local-market research information on sites, investigators, and competing studies
• Ensure compliance with AstraZeneca’s Code of 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 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 applicable local, national, and regional regulations
• Ability to use CTMS and other study systems
• Ability to perform Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV)

• Fully remote work arrangement
• Standard Monday-Friday work schedule