MsBelinda Fazekas

I registered as a General Nurse in 1981 working in the area of chronic, cancer and palliative pain management. I am the National Project Officer at the IMPACCT Trials Coordination Centre (ITCC), providing infrastructure, governance and coordination for multisite phase II, III and IV clinical research studies. I have worked across multi-site clinical trials for 15 years and I am integral in the implementation of clinical trial protocols including protocol design, case report form design, data management, ethics submissions, and reporting of site progress. Adherence to the principles of Good Clinical Practice, Australian regulations, and ethics and governance requirements, is applied at all times.

I work with each individual site to undertake study initiation, maintain trial requirements, undertake safety and data monitoring checks, and performance of study closure activities. Key attributes that I bring to the implementation of clinical trials includes the development of recruitment strategies, Key Performance Indicators and Standard Operating Procedures.

The ITCC team have developed the comprehensive process of risk based, central, and ‘for cause’ monitoring as applied to investigator led multi-site studies to ensure that the conduct of each study meet the highest standards possible. The recent revision of the ICH GCP (E6 R2) has vindicated the approach that I have applied over the last 10 years.