Senior CRA – FSP

• Take local responsibility for delivery of clinical studies at allocated sites
• Act as the main contact for study sites and monitor study conduct
• Prepare, initiate, monitor and close assigned clinical study sites
• Contribute to investigator selection and national investigator meetings
• Perform study start-up and regulatory maintenance activities where required
• Train, support and advise investigators and site staff on study-related matters and RbQM principles
• Confirm completion and documentation of required site staff training
• Participate in Local Study Team meetings
• 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
• Conduct remote and onsite monitoring visits and remote data checks
• Perform SDR, CRF review, SDV and site quality risk assessments
• Ensure timely data-query resolution and collaborate with data management
• 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 quality, data privacy, compliance and regulatory issues
• Assist sites with inspection-ready ISFs
• Support audits and regulatory inspections
• Ensure essential documents are uploaded to the eTMF and ready for archiving
• 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 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 manage study start-up, regulatory submissions and maintenance where required
• Ability to perform remote and onsite monitoring visits, SDR, CRF review and SDV
• Ability to use CTMS and other study systems
• Ability to manage study supplies, drug supplies and drug accountability
• Ability to resolve data queries and work with data management
• Ability to report Serious Adverse Events and follow-ups accurately and promptly
• Ability to prepare monitoring visit reports and follow-up letters
• Ability to support audits and regulatory inspections
• Ability to manage essential documents and eTMF requirements
• Compliance with AstraZeneca policies, procedures, Code of Ethics, and applicable legislation

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