AstraZeneca
Biopharmaceutical
ClinicalResearchAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Associate at AstraZeneca. Skills: Clinical trial monitoring, Site management, Regulatory compliance. Contribute to investigator selection. Support site feasibility”
What You'll Achieve.
Meet milestones reliably; Ensure compliance
Industry & Context.
Sound judgement
Travel to sites, Travel to Head office, 25% travel
What They're Looking For.
Must Have
Bachelors degree in life science, 1-2 years CRA experience, Independent monitoring experience, ICH-GCP knowledge, Australian regulatory requirements knowledge, Sound medical knowledge, Clinical Trial Management Systems experience, Veeva Clinical Vault familiarity, Ability to prioritize tasks, Ability to travel for visits, Current driving licence, Clear communication skills, Attention to detail, Sound judgement
Nice to Have
Oncology monitoring experience, Pharmaceutical sponsor experience, Comfort working with ambiguity, Risk-based monitoring familiarity, Remote monitoring familiarity
What You'll Do.
Contribute to investigator selection
Support site feasibility
Manage study start up
Manage regulatory maintenance
Ensure completion of trainings
Perform monitoring visits
Maintain study systems
Maintain study documentation
Report Serious Adverse Events
How You'll Work.
Team & Collaboration
Local Study Managers; Study site staff; Internal teams
Communication Scope
Confident communication
Process & Methodology
Manage multiple tasks
Full Job Description
Do you have expertise in complex clinical trial monitoring (like oncology)? Are you ready to make a difference in the world of clinical research in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! **About AstraZeneca** AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease. AstraZeneca Australia has been delivering the best value to patients for more than 60 years. We advance science to develop life-changing medicines. In Cell Therapy Site Management & Monitoring (SMM), we partner closely with investigators and internal teams to initiate, run and close clinical studies efficiently and compliantly, so patients can access innovative treatments sooner. **What you’ll do** As a Clinical Research Associate (CRA), you will be central to our local study teams. You will play a key role in delivering start‑up and monitoring for new, technically advanced cell therapy studies. You will work alongside Local Study Managers and peers to meet milestones reliably and ethically. You'll be the primary contact for study sites, responsible for monitoring study conduct and ensuring compliance with international guidelines and local regulations. With opportunities for growth and additional responsibilities, this role is perfect for those looking to advance their career in clinical research! This is a full time, 12-month contract position based in Sydney, reporting to the Senior Director, SMM Cell Therapy. You’ll work remotely, travelling to sites and Head office in Sydney as needed. **Key Responsibilities:** * Contribute to selection of potential investigators and support site feasibility. * Manage study start up and regulatory maintenance, including p
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