First-in-Human Diabetes Trials: Ethics & Admin Lead

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

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.