Clinical Trial Quality Officer
The University of Melbourne
We take pride in our people, who all contribute to our mission to benefit society through the transformative impact of education and research.
Your next career opportunity
In this role, you will strengthen the quality and compliance of clinical trials across the University. You will audit research governance, advise investigators and support training that ensures safe, ethical, regulatory-compliant studies.
What you will deliver
- Conduct audits and inspections of University-sponsored clinical trials against protocols, GCP, policies and regulatory requirements.
- Contribute to developing, implementing and refining clinical trial governance processes, standard operating procedures (SOPs), and related documentation.
- Identify compliance risks and root causes, recommending targeted training and process improvements with measurable impact.
- Provide GCP and regulatory advice to investigators and research staff across diverse clinical and academic sites.
- Support preparation for internal audits and external inspections and monitor implementation of corrective and preventive actions.
You may be a great fit if you
- Hold a tertiary qualification in a relevant science or healthcare discipline.
- Bring experience in clinical trial start-up, oversight and conduct within hospital, academic, pharmaceutical or Contract Research Organisation (CRO) environments.
- Demonstrate hands-on involvement in quality audits or inspections of clinical research activities or sites.
- Possess strong knowledge of GCP, NHMRC and TGA requirements, and national research ethics and governance frameworks.
- Have experience in quality or research management, including SOP development, review and continuous improvement.
- Excel at planning, organising and reporting, with meticulous attention to detail and clear stakeholder communication.
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