Senior Quality Assurance Associate
- Part time opportunity (0.4 - 0.5 FTE)
- 2 year, fixed term contract
- Flexible working arrangements available
- Respected global research organisation
- Make an impact on global health outcomes
The George Institute (TGI) is 700+ people around the world, all focused on improving the health of millions of people worldwide. As a medical research institute affiliated with leading universities and with projects in approximately 50 countries, we are challenging the status quo in healthcare to:
- Find better treatments for the world's biggest health problems
- Transform primary health care to support better health for more people
- Harness the power of communities, governments and markets to improve health
Our innovative commercial enterprises help maximise our impact. Please visit 'what we do' to read more about how we are addressing the world's biggest health problems.
We have a new and exciting opportunity for a Senior Quality Assurance Associate to join our growing Centre for Operational and Research Excellence (CORE) team.
The Centre for Operational and Research Excellence (CORE) is responsible for delivery and implementation of the Institute’s research strategy globally. CORE consists of three groups: Research Strategy and Services, Global Project Operations and Statistics. CORE’s aim is to provide high quality expertise as well as centralised and integrated research management systems and services to ensure effective and high-quality delivery of each TGI’s research program from its design to its outputs.
The successful Senior Quality Assurance Associate will be responsible for supporting research operations in achieving quality processes, compliance, risk review and management through establishing regional processes in line with the global quality assurance framework.
Key responsibilities of the role will include, but are not limited to:
- Establishing the risk management process and conducting project risk review and escalations for Australia
- Coordinating the review of Policies and SOPs, WIs and related ADs, and adjusting to meet regional requirements through feedback towards improvements
- Managing project/clinical trials insurance and liaise with the broker and internal team as required, including provision of the annual listing
- Working with researchers to maintain annual compliance of the Research Code of Conduct Policy through creating awareness and mandatory training
- Supporting the use of SPoT (the 'Single Point of Truth' database project) and ensuring the quality of the data in SPoT databases to be accurate, up-to date and complete
- Working closely with the Quality Assurance Manager, assisting to resolve issues related to compliance, risk and breached of the research code of conduct
Success will be based on a range of key skills and experience, including but not limited to:
- Tertiary qualifications in a health-related field, or relevant equivalent work experience
- A minimum of 5 years’ experience in research operations environment e.g. project operations, safety, data management or project systems.
- Good computer knowledge and skills in using various tools, applications and systems
- Knowledge of ICH-GCP guidelines, ethical and regulatory research requirements
- Strong interpersonal and written communication skills
- Strong problem solving and analytical skills
- Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments
- Strong focus and interest in continuous improvements
- Knowledge of risk management strategies or operational risk overview within a health research environment
This is a great opportunity for you to work on exciting projects and make an impact on global health outcomes.
For more information, please see the Position description here.
The closing date for applications is Sunday 3rd October 2021. We do, however, reserve the right to close this vacancy early if a suitable candidate is found.