Research Quality Officer
CurrentArea of work:• Developing, reviewing, and maintaining the Standard Operation Procedures (SOPs) at the research department in one of the largest non-profit private hospital in Victoria, Australia.• Implementing training curriculum for new clinical researchers• Conducting internal process audits of clinical research projects• Conducting Corrective and Preventative Action (CAPA) / Root-Cause Analysis (RCA) for clinical research incidents such a protocol breaches and deviations.• Reviewing Safety Reports such as Suspected Unexpected Serious Adverse Report (SUSAR), and Significant Safety Issues (SSI)• Processing documentations required for clinical trials and clinical quality registries governance authorisation.• Writing Annual Research Quality reports• Liaising with various departments in the hospital such as clinical governance, legal, and risk management• Liaising with external human research ethics committee.