Research and Data Compliance Assistant

6 months ago

Fitzroy, Australia University of Melbourne Full time

**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:

- 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.

**Aboriginal and Torres St

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