Clinical Research Associate I

• Deliver clinical studies at allocated sites and participate in local study teams
• 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, where applicable, study start-up and regulatory maintenance
• 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 investigator meetings
• Drive site performance and resolve or escalate study-related issues
• Update CTMS and other systems with study-site data
• Manage study, drug supplies and drug accountability
• Perform remote and on-site monitoring visits and remote data checks
• Perform SDR, CRF review, SDV and site quality risk assessments
• Ensure timely data-query resolution and accurate Serious Adverse Event reporting
• 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 and compliance issues
• Assist sites with 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
• Provide local-market research feedback and collaborate with local MSLs
• Ensure compliance with ethics, company policies, legislation and safety requirements

• 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 accepted in lieu of degree
• Ability to comply with AZ Procedural Documents, ICH-GCP, local regulations, company policies and procedures
• Ability to perform remote and on-site monitoring visits
• Ability to use CTMS and other study systems
• Ability to perform Source Data Review, Case Report Form review and Source Data Verification

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