Clinical Research Associate I

• Deliver clinical studies at allocated sites as part of the local study team
• Serve 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, where applicable, study start-up and regulatory maintenance
• Train, support, and advise investigators and site staff on study-related matters and RBQM principles
• Confirm required site staff training and maintain inspection readiness
• Participate in local study team and national investigator meetings
• Drive site performance, identify and resolve study issues, and escalate appropriately
• Update CTMS and other systems with study-site data
• Manage study, drug, and study-supply accountability
• Perform remote and on-site 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 data quality
• Report Serious Adverse Events and follow-ups accurately and promptly
• Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate quality, data privacy, CSP, or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready ISFs
• Support audits and regulatory inspections
• Collect and upload essential documents to the eTMF and prepare documents for archiving
• Provide local market research-related feedback on sites, investigators, and competing studies
• Ensure compliance with AstraZeneca policies, Code of Ethics, legislation, and applicable regulations
• Collaborate with local MSLs as directed

• 0–2 years of prior relevant experience
• Good knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Written and verbal communication skills
• Good command of English
• Degree in a scientific discipline or health care, or equivalent combination of education, training and experience may be accepted in lieu of degree

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