Senior CRA – Level I

• Contribute to selecting potential investigators
• Support study start-up and regulatory maintenance, including site qualification visits and submissions to EC/IRB and regulatory authorities 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, including ICH-GCP training
• Participate in Local Study Team and National Investigators meetings
• Initiate, monitor, and close study sites in compliance with procedural requirements
• Share patient recruitment and study-site progress information with 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; prepare study drug for destruction when applicable
• Perform remote and onsite monitoring visits and remote data checks
• Perform Source Data Review, Case Report Form review, and Source Data Verification
• Conduct Site Quality Risk Assessments and adapt monitoring intensity
• Ensure timely data-query resolution and collaborate with data management on data quality
• Ensure accurate and timely Serious Adverse Event reporting and follow-ups
• Prepare and finalize monitoring visit reports in CTMS and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready Investigator Site Files
• Support audits and regulatory inspections
• Ensure timely collection and uploading of essential documents to the eTMF
• Prepare study documents for final archiving and completion of the local eTMF
• Provide local-market research information 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 compliance with ICH-GCP, AZ Procedural Documents, local regulations, and AZ SOPs
• Ability to conduct remote and onsite monitoring visits
• Experience with CTMS, eTMF, SDR, CRF review, and SDV
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to ensure timely reporting of Serious Adverse Events and follow-ups
• Ability to support audits, regulatory inspections, and inspection readiness
• Compliance with AstraZeneca’s Code of Ethics and company policies
• Compliance with local, national, and regional legislation

• Fully remote work arrangement
• Full-time employment