Senior CRA – FSP

• Take local responsibility for delivery of allocated clinical studies at assigned sites
• Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study commitments
• 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, where required, study start-up and regulatory maintenance
• Collect, prepare, review, track, and submit regulatory and ethics committee/IRB documents
• Train, support, and advise investigators and site staff, including on Risk Based Quality Management principles
• Confirm required site training completion, including ICH-GCP training, and maintain inspection readiness
• Participate in Local Study Team and applicable National Investigators meetings
• Drive site performance, identify and resolve study-related issues, and escalate issues as appropriate
• Update CTMS and other systems with study-site data
• Manage investigator site files, drug supplies, drug accountability, and drug destruction preparation
• Perform remote and onsite monitoring visits and remote data checks according to the Monitoring Plan
• Perform Source Data Review, Case Report Form review, and Source Data Verification
• Conduct Site Quality Risk Assessments and adapt monitoring intensity
• Resolve data queries and collaborate with data management on 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 and escalate systematic or serious quality issues
• Assist sites with inspection-ready investigator site files
• Prepare for and collaborate on 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 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
• Knowledge and application of ICH-GCP, AZ Procedural Documents, relevant local regulations, and AZ SOPs
• Ability to conduct monitoring visits, remote data checks, SDR, CRF review, and SDV
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to update CTMS and other study systems
• Ability to ensure timely SAE reporting and data query resolution
• Ability to prepare monitoring visit reports and maintain essential documents in the eTMF
• Ability to support audits and regulatory inspections
• Ability to ensure compliance with company policies, legislation, ethics, privacy, and safety requirements

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