Clinical Research Associate
We are actively building a talent pipeline for Clinical Research Associate positions within our Biopharma and Oncology teams in Sydney, with recruitment anticipated later in 2026.
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, elevate 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.
Date Posted
09-June-2026
Closing Date
12-June-2026 Legal and Equal Opportunity Statement
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 the form.
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 is. 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.
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