Clinical Trials Governance Officer

Job title: Clinical Trials Governance Officer

Company: The University of Melbourne


Job description:

• 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 forYou 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.This role requires the successful candidate to undergo and maintain an up-to-date Working with Children Check. This is essential to guarantee a secure environment for all individuals at the University. In the case the selected candidate doesn’t have a valid Working with Children Check, they will be able to apply for the WWCC as part of the initial onboarding procedures.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 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 and stay connected with our stories and people on .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 page.We are dedicated to ensuring barrier free and inclusive practices to recruit the most talented candidates. If you require reasonable adjustments, please contact the employee listed on the first page of the Position Description found below, with an email containing your name and contact details for a confidential discussion. Please ensure your email is titled “Reasonable Adjustments Request”.Aboriginal and Torres Strait Islander Applicants
We aspire to be the University of choice for Indigenous Australians, with unprecedented investment to attract, nurture, and retain Aboriginal and Torres Strait Islander students and staff. Tangible support through a range of programs and initiatives will ensure that you personally succeed and flourish while at the University of Melbourne.For further information, including our 2023-2027 Indigenous strategy please visit –Join Us!
If you feel this role is right for you, please apply with the following documents:

• Resume
• Cover Letter outlining your interest and experience

Please note that you are not required to respond to the selection criteria in the Position Description.If you have any questions regarding the recruitment process, please feel free to contact Rehan via email at , ensuring that you include the Position Number and the Job Title as the subject. Please do not share your application to this email address.If you have any particular questions regarding the job please follow the contact details listed on the Position Description.Advertised: 10 Feb 2025 12:05 AM AUS Eastern Daylight TimeApplications close: 24 Feb 2025 11:55 PM AUS Eastern Daylight Time

Expected salary: $119742 – 129607 per year

Location: Parkville, VIC

Job date: Tue, 11 Feb 2025 07:47:04 GMT

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