University of Melbourne Hiring for Research and Data Compliance Assistant at Parkville, Victoria, Australia Full Time

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 s, and annual s.
• 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.

If you have any particular questions regarding the job please follow the details listed on the Position Description.