Senior Clinical Research Associate I

• Deliver clinical studies at allocated sites and participate in 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 study start-up activities
• Support regulatory submissions and maintenance with EC/IRB and Regulatory Authorities where required
• 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 Investigators meetings as applicable
• Drive site performance and resolve or escalate study-related issues
• Update CTMS and other systems with study-site data
• Manage study supplies, drug supplies, drug accountability, and drug destruction where applicable
• Perform remote and onsite monitoring visits and remote data checks
• Perform SDR, CRF review, SDV, site quality risk assessments, and adapt monitoring intensity
• Ensure timely query resolution and collaborate with data management on study-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 issues, data privacy breaches, CSP, or ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready ISFs
• Collaborate on audits and regulatory inspections
• Collect and upload essential documents to the eTMF and support QC checks
• Ensure study documents are ready for final archiving and eTMF completion
• Provide research-related information useful for the local market
• Ensure compliance with AstraZeneca’s Code of Ethics, policies, procedures, and applicable legislation
• Collaborate with local MSLs as directed

• Minimum 3–5 years’ experience as a monitor
• Ability to work independently and monitor all stages of a study, across different phases
• Often has special therapeutic expertise
• Ability to take on LSL tasks and support the LSL in coordination or document preparation as required
• Ability to travel internationally as required
• Valid driving license
• Compliance with ICH-GCP, AZ Procedural Documents, AZ SOPs, local, national and regional legislation, and AstraZeneca policies and procedures
• Ability to perform clinical research monitoring, including SDR, CRF review, SDV, remote data checks, site quality risk assessments, and monitoring visits
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to use CTMS, eTMF, and other study systems
• Ability to support regulatory submissions, study start-up, and regulatory maintenance where required
• Ability to train and advise investigators and site staff
• Ability to ensure timely reporting of Serious Adverse Events and follow-ups

• Fully remote work arrangement
• Full-time employment