Senior CRA – Level I

• Deliver assigned 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 for 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, document preparation, and submissions to EC/IRB and regulatory authorities
• Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles
• Ensure sites are inspection ready and required training is completed and documented
• Drive site performance, resolve study issues, and escalate issues appropriately
• Update CTMS and other systems with site data
• Manage study, drug, and drug-accountability supplies
• 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 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
• Escalate systematic or serious quality issues, data privacy breaches, CSP, or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready investigator site files
• Support 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 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
• Completion and documentation of required training, including ICH-GCP training, prior to and throughout the study
• Knowledge of ICH-GCP, AZ Procedural Documents, international guidelines, and relevant local regulations
• Compliance with AstraZeneca’s Code of Ethics, company policies, procedures, and applicable legislation

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