University of Melbourne

University of Melbourne

Research and Data Compliance Assistant



Research and Data Compliance Assistant

Job no: 0053967 Location: Hospital-based (Fitzroy) Role type: Part Time (0.4 FTE); Fixed Term for 24 months Faculty: Faculty of Medicine, Dentistry and Health Sciences Department: Department of Medicine – St Vincent's Hospital Salary: UOM 4 – $73,943 - $78,476 p.a. pro rata plus 17% super

  • Join the Diabetes Technology Research Group (DTRG) at St Vincent's Hospital to support the Clinical Trial Manager in research projects.
  • Play a key role in supporting clinical trial activities, ensuring quality and accuracy at every stage.
  • Salary packaging, subsidised health and wellbeing services, fitness and cultural clubs, Myki discounts, and a 25% discount on graduate courses to our staff and their immediate families!
  • About the Role

    Based at St Vincent's Hospital within the Diabetes Technology Research Group (DTRG) at the University of Melbourne, the role primarily focuses on data management, Good Clinical Practice (GCP) compliance, and supporting clinical trial activities. This includes overseeing ethics submissions, ensuring data quality and accuracy in clinical trials, and maintaining compliance with GCP regulations. The role involves collaborating with various team members, such as research fellows, coordinators, study doctors, and students, while also assisting with archiving and other administrative tasks.

    Your responsibilities will include:

  • Managing the submission of ethics and governance applications for the Diabetes Technology Research Group (DTRG) and ensuring compliance with protocol amendments, safety reports, and annual reports.
  • Handling data management in the Clinical Trials Management System (CTMS) platform and providing support for clinical trial data requirements.
  • Ensuring compliance with Good Clinical Practice (GCP) regulations, institutional policies, and sponsor requirements regarding source data and documentation.
  • Managing data entry, quality, and confidentiality, including RedCap creation, data review, and cleaning for clinical trial data, as well as archiving project documents when completed.
  • Who We Are Looking For

    You will bring excellent interpersonal and communication skills as well as self-motivation, flexibility, and ability to work independently and as part of a team. You will demonstrate familiarity with Good Clinical Practice (GCP) and knowledge of clinical trial research guidelines.

    You will also have:

  • A relevant diploma qualification combined with relevant experience, or an equivalent combination of relevant experience and/or education/training.
  • High-level computing skills, including databases, clinical trial electronic data entry, word processing, and spreadsheets.
  • Familiarity with Good Clinical Practice and current GCP accreditation.
  • Knowledge of the requirements of the affiliated Institutional Ethics Committee (IEC) according to the Therapeutic Goods Administration (TGA) guidelines for Good Clinical Research Practice (GCRP).
  • For further information regarding responsibilities and requirements, please refer to the attached PD.

    This position requires the incumbent to hold a current and valid Working with Children Check to ensure the University provides a safe environment for everyone.

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

    Your New Team – Department of Medicine

    The Department of Medicine is a large and diverse department in the Melbourne Medical School that undertakes research, postgraduate and undergraduate teaching within the University of Melbourne teaching hospitals. The objectives of the Department of Medicine at St Vincents are to provide clinical and research leadership from the interface of basic science and clinical medicine across the medical disciplines, to teach undergraduate and postgraduate students, to perform high quality research, and to provide leadership in national medical and scientific bodies.

    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!

    About 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.

    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 the email address listed at the bottom of the page.

    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 -https: //

    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 Katherine Robertson via email at [email protected], 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 details listed on the Position Description.

    Advertised: 13 Nov 2023 12:05 AM AUS Eastern Daylight Time

    Applications close: 04 Dec 2023 11:55 PM AUS Eastern Daylight Time

    Job details


    Research and Data Compliance Assistant


    University of Melbourne




    November 13, 2023

    Application deadline

    December 04, 2023

    Job type



    Medicine,Social Science

    About the employer

    When the University of Melbourne was established in 1853, it was a mere cluster of buildings in a large park on the fringe of the city, with four professors and 16 students. The university now sits at the heart of a thriving international city and is consistently ranked among the leading universities in the world and number one in Australia. 

    Over 8,000 academic and professional staff support a vibrant student body of around 65,000, including 30,000 international students from over 130 countries around the world. Four Australian prime ministers and five governors-general have graduated from the University of Melbourne, located in the city dubbed Australia’s “cultural capital”. 

    Indeed, Melbourne is a seven times winner of the Economist’s World’s Most Livable City award, and is a UNESCO City of Literature, as well as the birthplace of Australian rules football and a major center for street art, music, and theatre. 

    Melbourne is known for offering students an experience that’s a lot more than just structured learning. The main Parkville campus is close to transport, cafes, shopping, arts and sports venues and accommodation. 

    Students will find a blistering array of cultural activities on campus here, be it theatre, comedy, film or public lectures, and it’s easy to find people with matching interests by joining one of over 200 affiliated clubs and societies, ranging from Chess Club to Women in Science and Engineering, to the Chocolate Lovers’ Society. Sports enthusiasts are well catered for too, with a 25-metre six-lane heated indoor pool, an athletics track and sports field, and a large strength and fitness gym. 

    The university has 10 residential colleges where most students live, which provide a quick way to build an academic and social network. Each college provides sporting and cultural programs to enrich the academic experience, which is at the center of university life. 

    Degrees at the University of Melbourne stand out for being modelled on those from top institutions overseas. Students spend a year exploring a range of subject areas before choosing a major. They also study subjects outside as well as inside their chosen discipline, giving Melbourne students a breadth of knowledge that sets them apart.

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