Clinical Research Ethics Specialist & Admin

UOM University of Melbourne; Melbourne; On-site; AUD 101,000 - 109,000; Full time

Benefits offered by this job

17% superannuation

Salary packaging

Health and wellbeing programs

Professional development opportunities

Discounted services

Job summary

The University of Melbourne seeks a Clinical Research Ethics Specialist & Admin to lead ethics and governance submissions for pioneering diabetes trials at St Vincent’s Hospital. You will join a collaborative research group where your administration supports life-changing technologies.

You will coordinate HREC submissions, develop trial documentation, manage contracts, and ensure compliance with GCP/SOPs across hospital and university sites.

Qualifications

• At least twelve months’ experience coordinating or reviewing HREC applications and governance in clinical research.
• Understanding of Australian clinical trial activation requirements for medical device studies with local and international collaborators.
• Extensive knowledge of ICH GCP guidelines, including ICH E6(R3).

Responsibilities

• Prepare high quality HREC and governance submissions from feasibility to approval for Diabetes Technology Research Group trials.
• Develop protocols, consent forms and Australian research documentation, and coordinate clinical trial contracts and notifications.
• Maintain clinical trial management systems, documentation and financial processes, ensuring compliance with GCP and SOPs.
• Provide administrative support for clinical trials, including study payment activities and study equipment and supply purchases/distribution to sites.
• Provide administrative support across University and hospital sites, including meetings, minutes, stakeholder correspondence and document preparation.
• Contribute to training new staff, promoting ethical practice and data confidentiality.

Skills

HREC submissions

Governance reviews

ICH GCP knowledge

Regulatory liaison

Document management

Education

Tertiary Health/Life Sciences

Tools

ERMs

CTMS

Job description

Role type: Full-time; Fixed-term (1 year) Faculty: Medicine, Dentistry and Health Sciences Department/ School: Department of Medicine, St Vincent’s Hospital Salary: UOM 6 - $100,847 - $109,163 p.a. plus 17% super

Work on first-in-human diabetes technology trials / shape high-impact ethics and governance / grow specialist clinical research expertise

Investing in you – 17% superannuation, benefits package including salary packaging, health and wellbeing programs, discounted services, and professional development opportunities.

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

You will lead ethics and governance submissions that enable pioneering diabetes clinical trials at St Vincent’s Hospital. You will join a passionate research group where your administration skills directly support life-changing technologies.

What you will deliver

• Prepare high quality HREC and governance submissions from feasibility to approval for Diabetes Technology Research Group trials.
• Develop protocols, consent forms and Australian research application documentation, and coordinate clinical trial contracts and notifications.
• Maintain clinical trial management systems, documentation and financial processes, ensuring compliance with GCP and SOPs.
• Provide administrative support for clinical trials, including study payment activities and study equipment and supply purchase and distribution to participating sites.
• Provide administrative support across University and hospital sites, including meetings, minutes, stakeholder correspondence and document preparation.
• Contribute to training new staff, promoting ethical practice, data confidentiality and collaborative relationships across the research group.

You may be a great fit if you

• Bring at least twelve months’ experience coordinating or reviewing HREC applications and governance in clinical research.
• Understand Australian clinical trial activation requirements for medical device studies with local and international collaborators.
• Apply extensive knowledge of ICH GCP guidelines, including ICH E6(R3), to evolving research practice.
• Use ERMs and clinical trial management systems confidently to manage documentation, workflows and regulatory correspondence.
• Demonstrate strong organisation, attention to detail and time management, meeting complex deadlines with minimal supervision.
• Hold a relevant tertiary qualification in Health or Life Sciences and experience in hospital or research settings.

What we offer you

• Build future financial security with 17% superannuation
• Supportive flexible work arrangements underpinned by our commitment to inclusion and well-being
• Career development opportunities, including access to a range of tailored programs, such as Academic Women in Leadership, and learning platforms including LinkedIn Learning
• Progressive, considerate leave provisions to empower your work-life balance and well-being, including leading parental leave, gender affirmation leave, cultural leave, and menstruation and menopause leave.
• Salary packaging and access to a range of discounted services including Bupa health insurance, and access to unique cultural and recreational benefits such as discounts for the Melbourne Theatre Company
• Health and well-being services including a leading Employee Assistance Program
• For more information check out our benefits page!

Your new team

You will join the Department of Medicine at St Vincent’s Hospital within the Melbourne Medical School. Here, clinicians and researchers collaborate on leading edge diabetes technology trials that aim to transform patient outcomes. You will be part of the Diabetes Technology Research Group, a supportive team passionate about ethical, impactful research.

Be Yourself

The University of Melbourne is an Equal Opportunity Employer and a child-safe organisation. The diversity of our community enriches us all, and we are committed to creating an inclusive and fair workplace where everyone is valued, respected, and empowered to succeed. We welcome applicants from all backgrounds, identities, and experiences. Discover more about Diversity and Inclusion at UniMelb. We're committed to a barrier-free recruitment process and ongoing workplace support, providing adjustments throughout. We warmly encourage applications from people with disabilities. Learn more about how we support an accessible recruitment process. Aboriginal and Torres Strait Islander Applicants We aspire to be the University of choice for Indigenous Australians. Visit our Indigenous staff page to learn more about our investment and support for Aboriginal and Torres Strait Islander staff. Indigenous applicants are encouraged to connect with our Indigenous Employment & Development team at [e-mail].

Applications close: 16 November 2026. 11:55 PM; Melbourne time zone.

Position Description: JR-019687 Clinical Research Ethics Specialist & Admin PD.docx

JR-019687 Clinical Research Ethics Specialist & Admin PD.pdf

For queries related to this specific position, contact Lei by emailing [e-mail]. For questions related to our recruitment process email Walid at [e-mail]. For recruitment adjustments contact Kim Groizard on [phone] or at [e-mail] (subject: 'Recruitment Adjustments').