Clinical Research Associate I

• Deliver assigned clinical studies at allocated sites as an active member of local study teams
• 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 matters and RBQM principles
• Confirm completion and documentation of required site 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 site data within required timelines
• Manage study supplies, drug supplies, and drug 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 work with data management on study-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, CSP, or ICH-GCP compliance issues
• Assist sites with 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 local-market research information and 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
• Compliance with AstraZeneca procedural documents, SOPs, Code of Ethics, company policies, and applicable legislation
• Ability to perform remote and on-site monitoring visits
• Ability to manage clinical study documentation, regulatory submissions, site records, CTMS/eTMF updates, study supplies, and drug accountability

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