Senior Ethics and Regulatory Officer

UniSC•UniSC Sunshine Coast, UniSC SouthBank, Health Hub Morayfield, BC

12d•A$95,986 - A$103,873•Hybrid

About The Position

UniSC Clinical Trials is seeking a Senior Ethics and Regulatory Officer to safeguard the integrity, quality, and compliance of clinical trials. This pivotal role involves providing specialist ethics and regulatory expertise throughout the trial lifecycle, collaborating with clinical teams, Sponsors, and CROs to secure approvals, maintain audit readiness, and ensure studies meet ICH Good Clinical Practice and regulatory compliance standards. The ideal candidate is a confident, detail-oriented professional experienced in complex environments and passionate about impactful research.

Requirements

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;
Ability to work independently and as part of a multidisciplinary team.

Responsibilities

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.