Clinical Research Associate II

• Contribute to the selection of potential investigators
• Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and regulatory submissions where required
• Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles
• Confirm required site staff training, including ICH-GCP training, and maintain inspection readiness
• Participate in Local Study Team meetings and National Investigators meetings as applicable
• Initiate, monitor, and close study sites
• Track patient recruitment and site quality/performance
• Identify and resolve study-related issues and escalate them as appropriate
• Update CTMS and other systems with study-site data
• Manage study and drug supplies and drug accountability
• Perform remote and onsite monitoring visits and remote data checks
• Perform Source Data Review, CRF review, and Source Data Verification
• 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 in CTMS 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 in maintaining inspection-ready Investigator Site Files
• Support audits and regulatory inspections
• Collect and upload essential documents to the eTMF and support quality-control checks
• Prepare study documents for final archiving and completion of the local eTMF
• Provide research-related information useful for the local market
• Ensure compliance with AstraZeneca's Code of Ethics, company policies, procedures, and applicable regulations
• 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 an equivalent combination of education, training and experience
• Ability to perform remote and onsite monitoring visits
• Ability to comply with AstraZeneca procedural documents, SOPs, ICH-GCP, and local, national, and regional regulations
• Ability to use CTMS, eTMF, and other study systems
• Ability to manage study supplies, drug supplies, and drug accountability
• Ability to perform Source Data Review, CRF review, and Source Data Verification

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