About Orygen

Orygen is Australia’s Centre of Excellence in Youth Mental Health and the largest translational research organisation dedicated to youth mental health in the world.

For over 30 years, Orygen has led groundbreaking early intervention and developed evidence-based models of care to improve the mental health outcomes of young people aged 12-25.

About the job

The Clinical Research Associate will contribute to and support the regulatory compliance of Orygen research projects to ensure Good Clinical Practice compliance as well as assist in the development and maintenance of the Quality Management System (QMS). A key aspect of this role is to ensure all research projects across Orygen are conducted in accordance with best practice.

Reporting to the Head of Sponsor Operations you will:

Study monitoring & reporting - Act as Sponsor CRA/monitor across Orygen-sponsored studies, from the development of risk-based monitoring plans and site visits through to safety oversight and close-out.
Regulatory & operations advice - Review study documents and guide Investigators and study teams on regulatory compliance, study design, and best practice.
Systems & quality assurance - Manage serious breaches and CAPA processes, drive SOP development, and support the eTMF roll-out.
Research governance - Ensure site activities align with Orygen's Research Governance Framework, helping streamline how research is conducted across Orygen-governed sites.
End-to-end clinical operations - Support studies from start-up and Investigational Product set-up through to eCRF/data management and post-approval reporting.

Skills and experience

The following criteria must be met for consideration for this position:

Minimum bachelor’s degree or comparable qualification in Science, Life Sciences or other Healthcare-related discipline.
Extensive background in Pharmaceutical, CRO, Biotech, or academic/medical research settings, with hands-on expertise across study start-up, conduct, and close-out (including Teletrials)
Strong working knowledge of ICH GCP, safety reporting, and implementation of quality systems including QMS processes.
Skilled in electronic Case Report Forms (e.g. REDCap), Trial Master File management, and review of protocols, PICFs, and study documentation.
A collaborative, detail-oriented professional who builds effective relationships across internal and external stakeholders, and thrives under pressure with competing priorities.

Benefits

$125,000 - $135,000 pro rata + 12% superannuation and $15,900 in NFP salary packaging + $2,600 meals and entertainment card.
Embrace the freedom of a hybrid work model, combining remote work with on-site collaboration.
Make a real impact on young people in a dynamic, youth-centered environment.
Work in a state-of-the-art facility co-designed with young people to advance youth mental health.
Support Orygen's mission for youth mental health and contribute to positive social change.

How to apply

If you’re ready to make a difference in youth mental health and be part of a collaborative, innovative team, apply now.

For the full position description, visit https://www.orygen.org.au/getmedia/47ef4eef-64d2-4f3c-bcd7-2d9d59c51a33/Sponsor-Operations-Specialist-PD-July-2026-final.pdf.aspx

This is a part or full time (0.8-1.0FTE) 2-year contract.

Applications will close on 2nd August (4pm), unless a suitable candidate is found sooner.

Before applying at Orygen, it’s important to understand that you may encounter sensitive information related to mental health as part of your work. Being aware of this and how it could affect you is essential in deciding if this is the right opportunity for you.

Orygen is committed to providing diverse, equitable and inclusive environments for Staff and anyone connected to Orygen. We strive to continue building a culturally safe workplace where our values underpin the way we work and our commitment to First Nations people of Australia, young people and their families, people with disabilities, LGBTIQA+ people and CALD communities. We strongly encourage applications from First Nations people.

Orygen is a child-safe organisation and is committed to promoting and protecting the safety and well-being of all young people and embedding safeguarding practices into all our programs and services. All employment appointments are subject to holding a valid working with children check and successful police check.

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