Senior Clinical Research Associate – FSP

• Take responsibility for local delivery of studies at allocated sites
• Participate actively in local study teams and collaborate with CRAs and LSAD
• Act as the main contact with study sites
• Prepare, initiate, monitor, and close assigned clinical study sites
• Contribute to investigator selection and national investigator meetings
• Support study start-up, regulatory maintenance, and submissions to EC/IRB and regulatory authorities where required
• Train, support, and advise investigators and site staff
• Confirm required site training completion and inspection readiness
• Monitor site performance, patient recruitment, study progress, and study-related issues
• Update CTMS and other systems
• Manage study supplies, drug supplies, and drug accountability
• Perform remote and onsite monitoring visits, remote data checks, SDR, CRF review, and SDV
• Conduct site quality risk assessments and adapt monitoring intensity
• Ensure timely data query resolution and accurate Serious Adverse Event reporting
• Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators
• Follow up on outstanding site actions and escalate quality, privacy, compliance, and regulatory issues
• Assist with inspection-ready ISF maintenance 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
• Provide local research intelligence 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 training
• Compliance with AZ Procedural Documents, ICH-GCP, local regulations, AstraZeneca policies, and applicable legislation

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