Clinical Research Associate I

• Deliver assigned clinical studies at allocated sites as an active participant in local study teams
• Serve as the main contact for study sites and monitor study conduct
• Prepare, initiate, monitor, and close assigned 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 them appropriately
• Update CTMS and other systems with site data
• Manage study supplies, drug supplies, and drug accountability
• Perform monitoring visits, remote data checks, SDR, CRF review, and SDV according to the Monitoring Plan
• Perform site quality risk assessments and adapt monitoring intensity
• 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 quality issues, data privacy breaches, and 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 prepare study documents for archiving
• Provide research-related market feedback on sites, investigators, and competing studies
• Ensure compliance with AstraZeneca policies, ethical standards, 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 health care, or equivalent combination of education, training and experience accepted in lieu of degree
• Ability to conduct monitoring visits, including remote and on-site visits
• Knowledge of study start-up, regulatory maintenance, site management, clinical data review, and quality risk assessment processes

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