Stellenbosch University, Faculty of ScienceClinical Trial Laboratory Manager and Scientist
Jan. 2002 - Jan. 2002I participated in an international clinical trial for FDA approval of a vaccine, in a ISO 15189 accredited laboratory. My duties included specimen reception, specimen management, specimen preparation, cryogenic storage of specimens, cryogenic shipment of specimens to the overseas analysing laboratory and interacting with clinical investigators and site monitors of Quintiles Clindepharm (now IQVIA). As the laboratory co-ordinator for the trial, my duties included acquisition of consumables, training a team of scientists to receive and process specimens, planning of shifts, monitoring results, ensuring that all paperwork was completed, preparation of accreditation quality checklists and reports, management of data and submitting progress reports to the head of department and the clinical trial management company. Following completion of the study documentation was checked in preparation for audit by the contracting company.