Clinical Research Associates

Astrazeneca

We are currently building our Site Management and Monitoring teams across Oncology and Cell Therapy, as a result we have multiple vacancies for Clinical Research Associates available now. These positions are 12 Month Contract opportunities and will be located in Sydney. At AstraZeneca, we’re united by a bold ambition: to transform patients’ lives through science. Across BioPharma and Oncology, we design and deliver high-quality, patient-centric clinical trials that translate deep biology into breakthrough medicines in cardiovascular, renal & metabolism, respiratory & immunology, and cancers where the need is greatest. As a Clinical Research Associate , you will own site activation and performance, direct risk-based monitoring to where it matters most, and safeguard patient safety and data integrity. You will partner with investigators, shape inspection readiness, and apply a forward-looking approach that challenges the status quo and accelerates launches. How will you use your judgment and influence to turn a promising protocol into a reliable, scalable trial outcome. What you’ll do Identify and evaluate sites and investigators, build collaborative relationships, and drive activation, enrolment and sustained performance. Coordinate EC/IRB and health-authority submissions, secure and maintain approvals, and manage essential documents to keep studies inspection-ready from day one. Train and support site teams on ICH-GCP and RbQM, embed compliance routines, and coach toward audit and inspection readiness. Conduct remote and onsite monitoring visits; perform Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (CRF) review; manage data queries; and adjust monitoring intensity based on risk signals. Ensure timely reporting of Serious Adverse Events (SAEs); proactively identify, escalate and resolve quality issues in line with AstraZeneca SOPs. Maintain CTMS and eTMF accuracy; manage study drug supplies and accountability; and deliver clear, timely monitoring reports and follow-up. Essential for the role Bachelor’s degree in a life science or related field (or equivalent experience). Solid understanding of the drug development process, ICH-GCP and relevant country regulations. Experience in site selection, activation and monitoring (remote and onsite) with strong documentation discipline. Proficiency with CTMS/eTMF and data-query management; familiarity with SDR/SDV/CRF review. Strong communication, stakeholder management and problem-solving skills; ability to work independently and as part of a cross-functional team. Willingness to travel for site monitoring; fluency in written and spoken business-level English. Desirable for the role Experience across CVRM or Respiratory & Immunology trials, including multi-country studies. Hands-on use of RbQM analytics/dashboards to prioritise monitoring and remediation. Proven contribution to accelerated start-up timelines and efficient site activation. Confidence in audits/inspections; track record coaching sites to readiness. Comfort with remote monitoring tools, eSource/ePRO and data-driven decision-making. Fluency in the local language in addition to English.