Clinical Trials and Research Quality Lead

About the role

If you enjoy embedding quality into practical systems that help research teams do their best work, this role offers real scope to make an impact.

We are seeking an experienced and proactive Clinical Trials and Research Quality Lead to support excellence across our clinical trials and research portfolio. This role will support the scoping, roll out and oversight of our institute’s Quality Management System (QMS) and help ensure our teams continue to meet high standards of quality, compliance and research integrity.

Working closely with clinical trials staff, clinicians, academic researchers, management and external stakeholders, you will play a key role in embedding practical, fit-for-purpose quality frameworks that support safe, ethical and well-governed research.

What you will be doing

• Support the scoping, roll out, oversight and continuous improvement of the institute’s Quality Management System (QMS).
• Supporting compliance with relevant clinical trials, health and medical research legislation, policies and guidelines.
• Promoting research quality, integrity and good governance across clinical trials and broader research activities.
• Working collaboratively with internal and external stakeholders to translate quality requirements into practical processes and tools.
• Using MS365 tools, including SharePoint Lists and Libraries, to support documentation, workflow management, reporting and quality improvement initiatives.
• Contributing to a culture of accountability, continuous improvement and high-quality research practice.

About you

You will be a confident quality professional who enjoys working across teams, solving problems and helping others understand and apply quality requirements. You will bring strong initiative, sound judgement and the flexibility to manage multiple priorities in a research environment.

Essential experience and skills

• Previous experience providing oversight of a Quality Management System.
• Previous experience in a clinical trials and/or health and medical research organisation.
• Knowledge of relevant legislation and policies, including ICH-GCP, the National Statement, the TGA’s regulation of clinical trials in Australia, and the framework for Research Integrity Advisors.
• A high level of initiative, flexibility and the ability to meet deadlines while balancing multiple priorities.
• Excellent interpersonal skills, with the ability to engage effectively with clinical trials staff, clinicians, academic researchers, management and external stakeholders.
• Proficiency in MS365 Office, including the use and customisation of SharePoint Lists and Libraries.

Desirable experience

• Knowledge of the National Clinical Trials Governance Framework and the National Health and Medical Research Council’s Research Quality Strategy.
• Proficiency in Power BI reporting, Power Automate and related APIs.

Why join us?

This is an opportunity to make a meaningful contribution to research quality and continuous improvement in a purpose-led health and medical research environment. You will work with dedicated professionals who are committed to improving health outcomes through high-quality, ethical and impactful research.

Further information

This position is 0.6 FTE (3 days per week) for an appointment period of 12-months fixed term. It has a requirement to be on-site for at least 2 days a week for in-person activities, remunerated at $100,000-120,000 base salary per annum, prorated, plus 12% superannuation and NFP entitlements.

Applications close Friday 18 September 5:00pm. Please note that applications will be reviewed as they are received and interviews are being scheduled in the following week from Monday 21 September to Friday 25 September.