Clinical Trial Associate

Job no: 0058320
Location: St Vincent's Hospital
Role type: Full-time (1.0 FTE); Fixed-term for 1 year
Faculty: Medicine, Dentistry and Health Sciences
Department/School: Department of Surgery, Melbourne Medical School
Salary: UOM 7 – $98,402 – $106,519 p.a. plus 17% super

The University of Melbourne would like to acknowledge and pay respect to the Traditional Owners of the lands upon which our campuses are situated, the Wurundjeri and Boon Wurrung Peoples, the Yorta Yorta Nation, the Dja Dja Wurrung People. We acknowledge that the land on which we meet and learn was the place of age-old ceremonies, of celebration, initiation and renewal, and that the local Aboriginal Peoples have had and continue to have a unique role in the life of these lands.

About the Department of Surgery, Melbourne Medical School
The Department of Surgery is based across the seven precincts of the Melbourne Medical School, all at key hospital sites, as well as conducting academic activities in surgery at other hospitals. Members of the Department of Surgery are involved in research and in both undergraduate and postgraduate teaching in surgery across the Melbourne Medical School. These activities are undertaken both within the Department, and more broadly on the hospital campuses.

The objectives of the Department of Surgery are: To perform high quality research from the interface of basic science and clinical medicine across the surgical disciplines; To teach undergraduate and postgraduate students; To provide research leadership in national medical and scientific bodies; and to engage the community with compassion.

About the Role
The Clinical Trial Associate will join a collaborative team of academics, clinicians and industry partners and experts in cartilage tissue engineering, guided regeneration, biomaterials development and 3D printing, and various other fields (i.e. surgery, biology, bioengineering, clinical trials, qualitative research and health economics).  The successful candidate will assist in implementing the First-in-human (FIH) trials for this cutting-edge research. The role will involve coordinating and assisting in developing the FIH trials for the ARISTOCRAT program and assist with other research activities within the Department of Surgery.

ARISTOCRAT (CARTILAGE-BASED STEM CELL THERAPIES TARGETING CARTILAGE LOSS TO PREVENT JOINT DEFORMITY AND FACIAL DISFIGUREMENT. A FRAMEWORK FOR POINT-OF-CARE MANUFACTURING AND DELIVERY) is a first of its kind in Australia, research driven, stem cell-based consortium that aims to advance therapies that will allow live cells to be 3D printed and used as a material for treatments. The goal of this innovative solution is to repair cartilage loss which leads towards burdensome joint deformity.

Responsibilities include:

• Assist in development of study database establishment, design and functionality, data quality and entry
• Undertake Human Research Ethics Committee approval processes and trial registration
• Assist with participating site initiation and training, and support site investigators with the ethics and governance of research by developing appropriate procedures and processes
• Set up data safety monitoring, including Data Safety Monitoring Committee activity and meetings, and reporting, collation, and monitoring of adverse events by participating sites

About You
You have significant experience in the planning, conduct, coordination, or management of clinical trials. You have effective organisational skills to plan and organise work to meet competing deadlines, and the ability to work as both a member of a multi-disciplinary team and independently with minimal supervision, showing initiative and flexibility.

You will also have:

• Post graduate qualification in nursing, science, health science or biomedical science or extensive relevant experience or an equivalent combination of relevant experience and/or education/training
• Good working knowledge of medical and laboratory terminology, a sound understanding of the principles of Good Clinical Practice (GCP) and an excellent knowledge of applicable Australian and international regulations and guidelines
• Proficient computer skills related to project management with proven ability to manage central document repositories, GCP template documentation, ethics submissions and other regulatory and institutional documentation
• Outstanding oral communication and interpersonal skills with a demonstrated ability to liaise with and influence a diverse range of stakeholders, in order to achieve desired outcomes

To ensure the University continues to provide a safe environment for everyone, this position requires the incumbent to hold a current and valid Working with Children Check.

Please note: To be considered for this role you must have current valid work rights for Australia.

About the University
The University of Melbourne is consistently ranked amongst the leading universities in the world. We are proud of our people, our commitment to research and teaching excellence, and our global engagement.

Benefits of Working with Us
In addition to having the opportunity to grow and be challenged, and to be part of a vibrant campus life, our people enjoy a range of rewarding benefits:

• Flexible working arrangements, generous personal, parental and cultural leave
• Competitive remuneration, 17% super, salary packaging and leave loading
• Free and subsidised health and wellbeing services, and access to fitness and cultural clubs
• Discounts on a wide range of products and services including Myki cards and Qantas Club
• Career development opportunities and 25% off graduate courses for staff and their immediate families

To find out more, visit https://about.unimelb.edu.au/careers/staff-benefits .

Be Yourself
We value the unique backgrounds, experiences and contributions that each person brings to our community and encourage and celebrate diversity.  First Nations people, those identifying as LGBTQIA+, females, people of all ages, with disabilities and culturally and linguistically diverse people are encouraged to apply. Our aim is to create a workforce that reflects the community in which we live.

Join Us!
If you feel this role is right for you, please apply with your CV and cover letter outlining your interest and experience.  Please note that you are not required to provide responses against the selection criteria in the Position Description.

We are dedicated to ensuring barrier free and inclusive practices to recruit the most talented candidates. If you require any reasonable adjustments with the recruitment process, please contact us at [email protected] .

Position Description