02 Aug
|
University of the Sunshine Coast
|
Sunshine Coast Regional
02 Aug
University of the Sunshine Coast
Sunshine Coast Regional
- UniSC Clinical Trials | Health Hub Morayfield, UniSC Southbank, South Brisbane or UniSC Sunshine Coast, Sippy Downs
- Level 6, $95,986 - $103,873 p.a., plus up to 17% employer superannuation
- Full-time (36.25 hours per week), 2 year fixed-term appointment
The Opportunity
UniSC has built a world‑class Clinical Trials operation delivering innovative, regionally focused research in partnership with healthcare providers, industry sponsors, and research organisations. In this pivotal role, you will help safeguard the integrity, quality, and compliance of clinical trials across the UniSC Clinical Trials network. Providing specialist ethics and regulatory expertise throughout the full trial lifecycle, you will work closely with clinical teams, Sponsors, and CROs to secure approvals, maintain audit readiness, and ensure studies meet the highest standards of ICH Good Clinical Practice and regulatory compliance. This opportunity is ideally suited to a confident, detail‑oriented qualified who thrives in complex environments and is passionate about supporting research that delivers real‑world impact.
You will
- Contribute to the coordination of research, specifically the ethics and regulatory compliance of studies, in accordance with the appropriate quality standards including ICH/GCP, UniSC CT’s standard operating procedures (SOPs), and applicable regulations, rules and guidance.
- Work collaboratively with the CTC team, Sponsors and Clinical Research Organisations (CROs) to ensure all projects across the UniSC CT network achieve ethics and regulatory approvals within established timelines and quality standards.
About you
You are an experienced ethics and regulatory professional with a strong grasp of clinical trials governance and a reputation for precision, integrity and sound judgement. You bring a calm, solutions‑focused approach to complex regulatory challenges and are comfortable working across multiple studies with competing priorities. Confident in your expertise, you communicate clearly with stakeholders and enjoy contributing to a team-oriented, high‑standards environment.
You will possess:
- Completion of a relevant tertiary qualification in Health Science/Bio‑Medicine with subsequent relevant experience or extensive experience with specialist expertise or an alternate equivalent combination of relevant experience and/or education/training;
- Comprehensive knowledge of ICH Good Clinical Practice and applicable regulations, policies and guidelines;
- Sound knowledge of the clinical trials regulatory and ethics landscape in Australia and a broad understanding of the regulatory frameworks internationally;
- High level computing skills (including databases, clinical trial electronic data entry, Microsoft Word and Excel);
- Comprehensive understanding of the privacy principles governing health information; and
- Ability to work independently and as part of a multidisciplinary team.
Equal Opportunity
UniSC is an equal opportunity employer, committed to diversity and inclusion. We encourage applications from all backgrounds, including those with disabilities, women in STEM, First Nations Peoples, and individuals of diverse cultures, genders, abilities, and experiences. We value achievement relative to opportunity and encourage your commentary on your achievements in this context.
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📌 Senior Ethics and Regulatory Officer (Sunshine Coast Regional)
🏢 University of the Sunshine Coast
📍 Sunshine Coast Regional