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Form of workJob no: 515350
Work type: full time, part time
Location: Sydney, NSW
Categories: Risk & Safety, Clinical/Medical Research
Quality Assurance Manager – Clinical Research Unit
Employment Type: 0.8 FTE - Full time (28 - 35 hours/week)
Duration: 2 year fixed term contract
Remuneration: $112,154 to $126,366 (plus 17% super & leave loading)
Location: Hybrid working from home and Kensington, NSW
About UNSW:
UNSW isn’t like other places you’ve worked. Yes, we’re a large organisation with a diverse and talented community; a community doing extraordinary things. Together, we are driven to be thoughtful, practical, and purposeful in all we do. Taking this combined approach is what makes our work matter. It’s the reason we’re one of the top 50 universities in the world and a member of Australia’s prestigious Group of Eight. If you want a career where you can thrive, be challenged, and do meaningful work, you’re in the right place.
The newly formed Clinical Research Unit (CRU) will work in partnership with existing services within UNSW Medicine & Health and will coordinate infrastructure and expertise from across UNSW and affiliate networks. Over time, the platform of services provided through CRU will include academic and operational support which will assist with developing high-quality research proposals followed by support for delivery of clinical trials and other clinical research projects.
Why Your Role Matters:
As the Quality Assurance (QA) Manager, you will play a key role in supporting the Operations Director and Program Operations Lead in the CRU to develop and deliver UNSW Medicine & Health’s CRU strategic priority around high quality clinical research.
The role will require stakeholder management with key groups within UNSW and collaboration with the UNSW affiliated network.
Responsibilities will include but not be limited to:
Lead the development of a CRU Research Quality Framework including processes, tools and systems for Risk and Compliance in the quality cycle of research operations.
Collaborate effectively with multiple stakeholders to assess already existing SOPs across UNSW and affiliate organisations to plan, develop and deliver a broad range of CRU operational SOPs which are harmonised with wider UNSW Research SOPs (eg. The Kirby Institute, The George Institute for Global Health, UNSW ethics and clinical trials governance).
Who You Are:
Tertiary qualifications in a health-related field, or relevant equivalent work experience.
Minimum of 7+ years’ experience in the conduct of clinical research operations e.g. Project management, monitoring and safety reporting, ethics compliance or risk management.
Experience in quality and risk management, preferably in a research environment. Experience with audits, highly desirable.
Good knowledge of ICH-GCP guidelines, global and local ethical and regulatory research requirements as well as principles of research integrity.
Demonstrated knowledge and experience in developing and implementing clinical research operations processes and tools.
Strong problem solving and analytical skills with effective clear interpersonal and written communication skills across various levels of stakeholders.
Adaptability and flexibility to handle a wide range of stakeholders, ambiguous conditions and changing competing priorities, with good computer knowledge and skills in using various tools, applications and systems.
Benefits and Culture:
UNSW offer a competitive salary and access to a plethora of UNSW-perks including:
17% Superannuation and leave loading
Flexible working
Additional 3 days of leave over the Christmas Period
Access to lifelong learning and career development
Progressive HR practices
More information on the great staff benefits and culture can be found here.
How to Apply:
Submit your application online before 11 April 2023 at 11:55pm. Your application should include a document addressing the Selection Criteria (skills and experience on the position description). A copy of the Position Description can be found on JOBS@UNSW.
Contact for role related questions:
Sally Hough - shough@unsw.edu.au
Please APPLY through the application portal and not via the contact above.
UNSW is committed to evolving a culture that embraces equity and supports a diverse and inclusive community where everyone can participate fairly, in a safe and respectful environment. We welcome candidates from all backgrounds and encourage applications from people of diverse gender, sexual orientation, cultural and linguistic backgrounds, Aboriginal and Torres Strait Islander background, people with disability and those with caring and family responsibilities. UNSW provides workplace adjustments for people with disability, and access to flexible work options for eligible staff.
The University reserves the right not to proceed with any appointment.
Position Description
Advertised: 21 Mar 2023 AUS Eastern Daylight Time
Applications close: 11 Apr 2023 AUS Eastern Standard Time
