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Senior Research Quality, Risk And Compliance Officer

The George Institute for Global Health Newtown, NSW (New South Wales)

Job Description

Our mission is to improve the health of millions of people worldwide.

  • Part time (0.8 FTE), 2 year contract
  • Hybrid working environment and flexible working conditions.
  • This is an opportunity for your career to make a difference. Engage in interesting projects and make an impact on global health outcomes. We are looking for an experienced Senior Research Quality Risk and Compliance Officer to join our organisation.

    The Opportunity:

    The Senior Research Quality Risk and Compliance Officer is responsible for coordinating all research quality assurance compliance and risk management processes implementation, maintenance and reporting. The role will work closely with research and operations staff in Australia and well as with the Quality Assurance team in other regional offices to ensure consistency of risk processes and compliance with research regulations and requirements across all George Institute research projects.

    Our Successful Candidate will be responsible for:

  • Develop and/or review SOPs, work instructions and associated documents (e.g. document templates) required for research operations
  • Design and deliver training on SOPs, quality, compliance and risk management processes and procedures, including identifying gaps to meet regional requirements.
  • Promote awareness and knowledge of quality assurance, compliance and risk management within research operations in Australia
  • Establish the risk review, escalation and reporting of project risk from the risk register in Australia
  • Establish and conduct project risk reviews in Australia
  • Coordinate and oversee the maintenance of content of the CORE sites on the internal Intranet
  • Promote the Research Code of Conduct Policy through creating awareness and mandatory Research integrity training.
  • Assist in the development of resources and awareness of research integrity amongst research operations
  • Assist the Research Integrity Officer (RIO) with any complaints and escalation of potential breaches, working with the Quality Assurance Manager and Director of CORE
  • Work with Australia project teams to ensure compliance with specific research operations regulatory, ethical and privacy requirements (e.g NHMRC, NIH, TGA, Conflict of Interest reporting, GDPR compliance, pharmacovigilance)
  • Ensure the quality of project data in The George Institute project database through monthly review and follow-up
  • Provide induction for new staff on CORE functions, use of The George Institute project database, risk reporting and research integrity
  •   Our ideal candidate will possess:

  • Tertiary qualifications in a health-related field, or clinical research experience
  • A minimum of 5 years’ experience in clinical research operations environment e.g. project operations, monitoring and safety reporting, ethics compliance or risk management.
  • Experience in quality management, audit and accreditation processes, preferably in a research environment
  • Good computer knowledge and skills in using various tools, applications and systems
  • Good knowledge of ICH-GCP, ethical and regulatory research requirements and research integrity principles
  • 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
  • Please see here for more information Position Description

    The closing date for applications is 15 March 2023. We do reserve the right to close this vacancy early if a suitable candidate is found. 

    About the George

    The George Institute (TGI) is 700+ employees around the world and projects in over 40 countries all focused on improving the health of millions of people worldwide.

    As a medical research institute affiliated with leading universities, we are challenging the status quo in healthcare to:

  • Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare delivery
  • Look beyond single diseases, across the life course, to identify patient-centred approaches to care that can be implemented at scale
  • Develop low-cost, innovative solutions to global unmet needs
  • Drive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurship
  • We pride ourselves with our 6 core values: excellence, integrity, can-do approach, creativity, impact, and humanitarian commitment.

    Please visit our website for more on The George: Home | The George Institute for Global Health

    Why the George?

    We are committed to attracting, developing, rewarding and retaining the best people in their fields to conduct and support our innovative and highest quality research programs.

    Take advantage of our rewards you may enjoy as part of The George team.

  • Generous salary packaging benefits increasing your take home pay
  • Learning and career development opportunities
  • Extra leave days including extended Christmas break and study leave
  • YourFlex arrangements e.g. start/finish times, purchase leave, location
  • A global, diverse, inclusive team committed to making impact
  • Please apply now!

    Our big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work.

    Everyone is encouraged to apply, including people with a disability; women; Aboriginal and Torres Strait Islander people; people who identify as LGBTIQ; mature-aged adults and those from culturally and linguistically diverse backgrounds.

    Apply Now

      This job vacancy was been posted over 40 days ago, but is still active and currently accepting new applications.

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    The George Institute for Global Health