Radhika is a passionate Clinical Researcher and Site Advocate with over 17 years of experience and expertise from Trial Coordination to Trial Unit establishment. She has diverse clinical trial expertise in interventional and device studies spread across multiple therapeutic areas. She has operational and managerial experience in the public, private, commercial and academic sectors within the clinical research industry and the Australian Healthcare sector. She is passionate about collaborating, educating and championing young people to seek careers in clinical research. In her current role as Manager of Clinical Trials & Research Unit (CTRU) at North Shore Private Hospital, she is establishing a clinical research unit.

Tanya has worked on Commonwealth and State government projects and for the UK National Institute of Health and Care Research (NIHR). She has authored or co-authored several national guidelines and resources, including the NIHR Clinical Trials Toolkit, the Australian Clinical Trials Handbook, the NHMRC Safety Monitoring and Reporting Guidelines and Serious Breach Guidelines, and the ACTA/CTIQ Consumer Involvement and Engagement Toolkit. Tanya has provided clinical trial and GCP training to over 80,000 people.

Dianne Biermann is the Research Quality Manager at Cabrini Health where she is responsible for the implementation of the National Clinical Trials Governance Framework. Dianne has over 15 years experience in research governance, health policy, and advocacy. She has a degree in Science and Postgraduate Diploma in Public Health. Dianne brings a valuable on the ground perspective of compliance with regulatory guidelines.

James Cokayne leads the Research Ethics and Governance Unit and the REGIS team at the NSW Office for Health and Medical Research (OHMR). With a medico-legal background he has worked extensively within the NSW Public Health System. He has also had significant involvement in the private health, university and non-government sectors. At OHMR, he is the NSW delegate on the NMA Interjurisdictional Working Group, part of the NSW delegation at the InterGovernmental Policy Reform Group (IGPRG) and before that on the Clinical Trials Project Reference Group (CTPRG) and has recently stepped down after 10 years as Chair of the SEBS (now NaCTA) Panel. He is the NSW Health advisor for research policy-related queries for Ethics, Governance, Insurance and Indemnity in Clinical Trials, Guardianship, Human Tissue and the Early Phase Clinical Trial HREC Framework. He is also the primary contact for Animal Ethics issues within NSW Health. James has bachelor’s degrees in Law (LLB)(Hons) and Health Information Management (HIM) and a master’s degree in Health Law (MHL).