Clinical Research Associate - Biopharma

We currently building out our Biopharma Site Management and Monitoring team, and we have a vacancy for a Clinical Research Associate available now based 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 highquality, patientcentric 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. Initially this role is a 12 Month Contract but there is potential scope for the role to be ongoing for the right person. What you'll do Identify and evaluate sites and investigators, build collaborative relationships, and drive activation, enrolment and sustained performance. Coordinate EC/IRB and healthauthority submissions, secure and maintain approvals, and manage essential documents to keep studies inspectionready from day one. Train and support site teams on ICHGCP 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 followup. Essential for the role Sydney Based Minimum of 3-5 Years experience as a Clinical Research Associate Bachelor's degree in a life science or related field (or equivalent experience). Solid understanding of the drug development process, ICHGCP and relevant country regulations. Experience in site selection, activation and monitoring (remote and onsite) with strong documentation discipline. Proficiency with CTMS/eTMF and dataquery management; familiarity with SDR/SDV/CRF review. Strong communication, stakeholder management and problemsolving skills; ability to work independently and as part of a crossfunctional team. Willingness to travel for site monitoring; fluency in written and spoken businesslevel English. Desirable for the role Experience across Biopharma trials, in particular metabolic, cardiology and respiratory Handson use of RbQM analytics/dashboards to prioritise monitoring and remediation. Proven contribution to accelerated startup timelines and efficient site activation. Confidence in audits/inspections; track record coaching sites to readiness. Comfort with remote monitoring tools, eSource/ePRO and datadriven decisionmaking. Fluency in the local language in addition to English. Why AstraZeneca? At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare. To Apply Please apply with a resume and cover letter outlining your suitable skills and experience applicable to this role. Where can I find out more? Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Visit our website: www.astrazeneca.com.au AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Gold Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers.html to learn more about our commitment to fostering a flexible, diverse, and inclusive environment. We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know via this Form Ready to make an impact? Apply to register your interest today. Date Posted 07-Aug-2026 Closing Date 21-Aug-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.