Clinical Research Associate I

• Deliver clinical studies at allocated sites and participate in local study teams
• 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
• Support study start-up and regulatory maintenance, including site qualification visits 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 and inspection readiness
• Participate in local study team and national investigator meetings
• Drive site performance and resolve or escalate study-related issues
• Update CTMS and other systems with site data
• Manage study supplies, drug supplies and drug accountability
• Perform remote and on-site monitoring visits, remote data checks, SDR, CRF review and SDV
• Perform site quality risk assessments and adapt monitoring intensity
• Ensure timely data query resolution and work with data management on data quality
• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups
• Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate systematic or serious quality, privacy and compliance issues
• Assist sites in maintaining inspection-ready ISFs
• Support audits and regulatory inspections
• Collect and upload essential documents to the eTMF and support QC checks
• Ensure study documents are ready for final archiving
• Provide research-related market feedback
• Ensure compliance with AstraZeneca ethics, policies, procedures and applicable legislation
• 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 healthcare
• Equivalent combination of education, training and experience may be accepted in lieu of a degree

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