Clinical Research Ethics Specialist & Admin

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

Benefits offered by this job

17% superannuation

Salary packaging

Health & wellbeing programs

Professional development opportunities

Job summary

The University of Melbourne is seeking a Clinical Research Ethics Specialist & Admin to lead ethics and governance submissions for first-in-human diabetes technology trials at St Vincent’s Hospital. You will join a collaborative Diabetes Technology Research Group and support life-changing research with strong administrative backing.

Responsibilities include preparing submissions, developing documentation, maintaining CTMS and ensuring GCP compliance, while coordinating across university and

Qualifications

• Experience coordinating or reviewing HREC applications and governance in clinical research.
• Familiar with Australian medical device trial activation requirements.
• Strong knowledge of ICH GCP guidelines and regulatory practices.

Responsibilities

• Prepare high quality HREC and governance submissions from feasibility to approval for Diabetes Technology Research Group trials.
• Develop protocols, consent forms and Australian documentation; coordinate contracts and notifications.
• Maintain trial management systems, docs and financial processes; ensure GCP/SOP compliance.
• Provide administrative support for trials, payments, and equipment logistics to sites.
• Support across University and hospital sites; coordinate meetings, minutes and stakeholder communications.
• Contribute to training staff and promote ethical practice, data confidentiality and collaboration.

Skills

HREC coordination

Governance submissions

ICH GCP knowledge

Clinical trial documentation

Organisational skills

Education

Bachelor's degree in Health or Life Sciences

Tools

CTMS (Clinical Trial Management Systems)

Job description

## Clinical Research Ethics Specialist & AdminApply: Clinical Sites (Metro & Regional): Full time: Posted Today: End Date: November 17, 2026 (13 days left to apply): JR-019687**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* Apply now to use your ethics expertise in research that transforms care for people with diabetes.* 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. Discover more via our website. **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. For further information please refer to the attached PD. **What we offer you!** We offer the opportunity to be part of a vibrant community and enjoy a comprehensive range of benefits to support your success and sense of fulfilment, including:* 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]. **Application essentials:*** Visit \"apply with us\" to learn more about the process, including tips and FAQs.* You must have current valid work rights for Australia. Visa sponsorship is not available for this role* A Working with Children Check is required for all positions. If successful, we will guide you through the process and reimburse you.* Please upload your resume and a cover letter outlining your interest and experience as part of the application process.* Please upload your responses to the Selection Criteria, found in the Position Description. **Learn more about responding to Selection Criteria** **Want to know more?*** 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'). Apply today, and join a community that’s shaping the future. **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