This course introduces clinical trials and the roles of lab staff, covering GCP, GLP, and GCLP in relation to trials. It highlights GCLP's importance in lab process monitoring, sample handling, instrumentation, data documentation, ethics, and quality assurance. Best practices for trial closeout focus on documentation, sample handling, and shipping processes.
Sarah started her career in 1982 as a Medical Laboratory Technologist for a Private Pathology Laboratory in Johannesburg; becoming Laboratory Manager (Microbiology), and progressed to working in medical research in 2001 as Laboratory Manager for the HIV Virology Laboratory at the National Institute for Communicable Diseases, Rietfontein, where she was responsible for the management and oversight of laboratory processes; doing basic research and working on various HIV Clinical trials in collaboration with clinical trial sites in South Africa. From 2011, Sarah worked as a Research Operations Manager for an academic research organisation, affiliated to Wits University, where she project managed operations (laboratory, pharmacy, quality and regulatory activities) for several investigator-initiated trials as well as multi-party/multi-site network studies (in collaboration with the HVTN & HPTN, CONRAD). Sarah has worked as a freelance consultant from August 2018 with a focus on oversight and assessment of clinical trial laboratories both local and international; compilation and review of healthcare related documents; training, coaching and mentoring of laboratory and clinical trial site staff and assisted with development of curricula and review of student theses. She lectures students on a part-time basis at the Tshwane University of Technology (Faculty of Science) and the Academic Advance (Wits Health Consortium) in Research Ethics, GCP, GCLP and Clinical Research. Sarah has experience in the infectious diseases area including STI/TB/HIV treatment and prevention. She attained a BTech Lab Management (TUT); a Master’s degree in Operations Management (UJ) and a Master’s degree in Business Administration from the Australian Institute of Business (2017). During her working career, Sarah has liaised extensively and built working relationships with the Southern African Laboratory and Diagnostics industry and other healthcare and research stakeholders both locally and abroad. She is a member of the following organisations: SACRA, HPCSA, Golden Key, ASLM, FIDSSA, IFBLS, MDPG.
