Senior CRA – Level I, FSP

• Deliver clinical studies at allocated sites and participate in local study teams
• Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study commitments
• Act as the main contact with study sites and monitor study conduct
• Prepare, initiate, monitor, and close assigned clinical study sites
• Contribute to investigator selection and national investigator meetings
• Support study start-up and regulatory maintenance, including site qualification visits and submissions to ethics committees, institutional review boards, and regulatory authorities
• Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles
• Confirm required site staff training and inspection readiness
• Initiate, monitor, and close sites; track recruitment and site performance
• Drive site performance, resolve study issues, and escalate appropriately
• Update CTMS and other systems with study-site data
• 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 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 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
• Collect and upload essential documents to the eTMF and support quality-control checks
• Ensure study documents are ready for final archiving and local eTMF completion
• 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
• Ability to perform advanced clinical trial monitoring
• Knowledge and application of ICH-GCP, AZ Procedural Documents, SOPs, international guidelines, and relevant local regulations
• Ability to train, support, and advise investigators and site staff
• Ability to manage study start-up, regulatory maintenance, monitoring visits, source data review, CRF review, source data verification, quality risk assessments, data queries, safety reporting, eTMF, audits, and regulatory inspections
• Compliance with AstraZeneca’s Code of Ethics, company policies, and applicable legislation

• Fully remote work arrangement