Senior CRA – Level I

• Contribute to selection of potential investigators
• Support study start-up and regulatory maintenance, including site qualification, document preparation, tracking, and submissions to EC/IRB and regulatory authorities
• Train, support, and advise Investigators and site staff on study-related matters and RbQM principles
• Confirm required site-staff training, including ICH-GCP, and maintain inspection readiness
• Participate in Local Study Team and National Investigators meetings
• Initiate, monitor, and close study sites in compliance with applicable procedures
• Share patient recruitment and site progress information within the LST
• 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, including drug destruction when applicable
• 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
• 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 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 with LSAD and CQAD
• 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 intelligence on sites, investigators, and competing studies for the local market
• Ensure compliance with AstraZeneca’s Code of Ethics, company policies, procedures, and applicable legislation
• 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 relevant legislation
• Ability to perform monitoring visits, remote data checks, SDR, CRF review, and SDV
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to use CTMS and other study systems
• Ability to ensure timely SAE reporting, data query resolution, and essential document submission
• Ability to collaborate with Investigators, site staff, Local Study Teams, data management, MSLs, LSAD, CQAD, and local management

• Fully remote work arrangement