Clinical trials governance officer (parkville)

Position No: 0051039

Location: Parkville

Role Type: Full‐time; Continuing

Department: Research, Innovation and Commercialisation

Salary: UOM 8 – $119,742 – $129,607 p.a. plus 17% super

The Clinical Trials Governance Officer, reporting to the Associate Director, Research Governance and Compliance, plays a crucial role in supporting the governance of the University's clinical trial activities. The role involves ensuring compliance with regulatory requirements, insurance, registration, ethics, training, and legal documentation, and liaising with stakeholders to uphold institutional governance standards in line with statutory and regulatory frameworks.

• Providing independent advice on clinical trial governance, including approval pathways, sponsorship responsibilities, key risks, and conditions for the University acting as sponsor.
• Collaborating with stakeholders to review policies, refine processes, and provide guidance for clinical trial governance, and liaising with regulatory bodies such as the Therapeutic Goods Administration.
• Managing the University's Clinical Trial Registers and ensuring appropriate contracts, risk management, insurance, and ethical approval are in place.
• Facilitating decision‐making, incident reporting, and maintaining strong relationships with stakeholders, while developing and delivering education and training on clinical trial governance.

• Experience in continuous improvement, policy implementation and the validation of systems and processes to support quality assurance.
• Excellent verbal and written communication skills, with the ability to engage a wide range of audiences effectively.
• A proven track record of working transparently and collaboratively, and the ability to manage a significant workload while prioritising tasks with solid organisational skills.
• A degree relevant to clinical trial governance and/or regulatory compliance, along with relevant experience and knowledge in clinical trial governance within a research context.
• In‐depth knowledge of investigator‐initiated clinical trials and the regulation of trials in a research setting.
• A proven track record of advising on regulatory requirements and reporting to internal stakeholders.
• Experience in delivering projects and a proactive approach to implementing initiatives that improve clinical trial governance.

Visa sponsorship is not available for this position. This role requires current valid work rights for Australia.

In addition, we offer the opportunity to be part of a vibrant community and enjoy a range of benefits including generous leave provisions, salary packaging, health and well‐being services, and discounts on graduate courses.

The University of Melbourne values the unique backgrounds, experiences, and contributions that each person brings to our community and welcomes and celebrates diversity. First Nations people, those identifying as LGBTQIA+, parents, carers, people of all ages, abilities, and genders, and people of diverse ethnicity, nationality, and faith are encouraged to apply. Our aim is to create a workforce that reflects the diversity of the community in which we live.