Quality and Risk Specialist - Morayfield, Australia - University of the Sunshine Coast

Olivia Brown

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Olivia Brown

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Description

Quality and Risk Specialist / Job ID 23165

  • UniSC Clinical Trials Centre | UniSC Morayfield Health Hub
  • Level 7, $94,738 $103,563 p.a., plus up to 17% employer superannuation
  • Fulltime, fixedterm appointment for 3 years
  • Utilise your clinical trial monitoring and phase I experience to add value to our growing Clinical Trials centre network without significant travel commitment

The Opportunity


UniSC has established a world class Clinical Trials business unit which builds the region's collective clinical research capacity and delivers innovative and regionally relevant research in consultation with key stakeholders, including local healthcare professionals, pharmaceutical executives, and other key thought leaders.


You will act as the local Quality and Risk lead within the Clinical Trials network for assigned sites, providing high level advice, support, and oversight of quality, compliance, and risk management activities.


Please note, this position will require a flexible approach, to travel between campuses and our clinical trial centres, as necessary.


You will**- assist with driving the implementation and improvement of the UniSC Clinical Trials network's Quality and Risk Management Plan;
- lead site-specific internal auditing function and external audit/inspection support;
- contribute significantly to enhancing the utilisation and ongoing development of UniSC Clinical Trials' newly launched electronic Quality Management System; and
- assist the Quality and Risk Manager in promoting a collaborative culture focussed on continuous improvement and Quality excellence.


About you
You will be process-driven with strong attention to detail and possess excellent communication and interpersonal skills. You will thrive working both autonomously and as part of a multi-disciplinary team. Additionally, you will enjoy showcasing your high-level computing skills Microsoft Office suite and remote communication tools.


You will possess:

- completion of a degree qualification in Health Science/Bio-Medicine or related field and relevant experience or an equivalent combination of experience and/or education/training;
- minimum 5 years' experience in a clinical research or clinical operations background, with at least 3 years' experience in a clinical research associate / clinical trial monitor role;
- phase I monitoring experience/exposure preferred;
- exposure to internal / external audits an advantage; and
- detailed knowledge of ICH GCP and national regulations.


Additional Requirements

It is a condition of employment for this position that you may be required to provide periodic evidence of immunisation against communicable diseases.

This may include COVID-19.


Contact

For a confidential discussion, please contact:
Tabitha Abbott

Quality and Risk Manager - UniSC Clinical Trials

Telephone:

To Apply
- a resume; and
- a statement of suitability (not to exceed two pages).


Benefits of working at UniSC
UniSC is a community which recognises and embraces diversity among our staff, students and community partnerships.

We provide an inclusive environment where each person feels they belong and are respected, connected and empowered to contribute and grow in meaningful ways.


UniSC is a proud recipient of the prestigious Athena SWAN Bronze Award, granted as part of the Science in Australia Gender Equity (SAGE) initiative which aims to address and improve gender equity in the science, technology, engineering, mathematics and medicine (STEMM) disciplines.

Attaining an award is recognition of our ongoing commitment to improving gender equity and ensuring that women from diverse backgrounds, as well as underrepresented groups, are best positioned to reach their full potential.


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