Ethics & Trials Admin Lead for Diabetes Tech Research

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

Benefits offered by this job

17% superannuation

Flexible work arrangements

Career development programs

Parental leave

Health insurance discounts

Job summary

The University of Melbourne is seeking a Clinical Research Ethics Specialist & Admin to lead ethics and governance submissions for pioneering diabetes clinical trials at St Vincent's Hospital. You will support trial setup, prepare documentation, and coordinate communications across hospital and university sites.

You will join the Diabetes Technology Research Group, contribute to compliant practice under ICH GCP guidelines, and help training new staff.

Qualifications

• At least twelve months' experience coordinating or reviewing HREC applications and governance in clinical research.
• Knowledge of Australian clinical trial activation requirements for medical device studies with local and international collaborators.
• Strong understanding of ICH GCP guidelines, including ICH E6(R3).
• Experience using ERMs and clinical trial management systems.
• Excellent organisation, attention to detail and ability to meet deadlines with minimal supervision.
• Relevant tertiary qualification in Health or Life Sciences and experience in hospital or research settings.

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 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.

Skills

HREC submissions

Governance coordination

ICH GCP knowledge

Regulatory documentation

ERMs familiarity

Education

Tertiary qualification in Health or Life Sciences

Job description

The University of Melbourne is seeking a Clinical Research Ethics Specialist & Admin to lead ethics and governance submissions for pioneering diabetes clinical trials at St Vincent's Hospital. You will support trial setup, prepare documentation, and coordinate communications across hospital and university sites.

You will join the Diabetes Technology Research Group, contribute to compliant practice under ICH GCP guidelines, and help training new staff.