Clinical Trials Governance Officer

**Clinical Trials Governance Officer**:
**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
- **Ensure governance and compliance for the University’s clinical trials, including regulatory requirements.**:

- **Play a pivotal role in overseeing high-impact clinical trials at a world-leading institution**:

- **Brilliant benefits and a flexible hybrid work environment**

**About the Role**
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.

Your responsibilities will include:

- 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.

**Who we are looking for**

You will have experience in continuous improvement, policy implementation and the validation of systems and processes to support quality assurance. You will demonstrate excellent verbal and written communication skills, with the ability to engage a wide range of audiences effectively. You will have a proven track record of working transparently and collaboratively, and the ability to manage a significant workload while prioritising tasks with strong organisational skills.

You will also have:

- 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.

For further information regarding responsibilities and requirements please refer to the attached PD.

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

**Your new team - Research, Innovation and Commercialisation (RIC)**
Research, Innovation and Commercialisation (RIC) is the central facilitator of research funding in the University, taking advantage of the full diversity of research funding opportunities. RIC is a specialist team dedicated to enabling the University's research and enterprise mission working closely with our academics, professional colleagues, industry partners, funding agencies and government agencies. We have a passion to see our academics and their collaboration partners succeed, achieve research excellence and translate their discoveries into real-world innovation and impact. RIC operates University-wide across all ten Academic Divisions and Chancellery.

**What we offer you**
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. For more information check out our benefits page

**The University of Melbourne**
We’re tightly connected with the community, both at home and abroad. 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 and stay connected with our stories and people on LinkedIn.

**Be yourself**
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. For more information please visit our Diversity and Inclusion page.

**Aborigina