"The amount of knowledge that SATVI personnel have, from the cleaners upwards, is impressive. They know what the aims of SATVI are, what is being done and what the routine is."
Thomas Scriba, Senior Research Officer
The SATVI Exco currently consists of a director, 3 Principal Investigators, a Field Site manager and COO. The function of this group is to set the strategic direction and ensure that all activities work towards achieving defined strategic objectives. In addition, this group takes decisions about new proposals/grants, high level HR and Finance decisions, as well as all decisions that impact the sustainability of SATVI. Within this group there is more than 4 decades worth of experience in doing lab and clinical trials.
SATVI's Middle Management Team consists of a Resource Manager, CV ward Manager, Surveillance Officer, Transport Supervisor, IT Officer, Data Manager, Laboratory Project Manager, Laboratory Manager, Pharmacists and Regulatory Specialist. This team is responsible for the planning, implementation, monitory and operational support functions for all research studies done at SATVI.
They are also responsible for systems development to support study activities and integration between all departments to focus on overall objectives of SATVI.
This is a vibrant team with years of research knowledge and skills and their strength lies in the specialty they bring to the combined team.
The SATVI team is headed by a director.
Senior research officers
Research Officers are qualified and experienced in infectious disease and clinical vaccine research. They contribute to and support novel TB vaccine research, and supervise clinical and epidemiological studies. Daily responsibilities include study-related medical decision-making, participant safety, operational direction of the project team, and the integrity, analysis, presentation, and reporting of the study data.
Postdoctoral research fellows
Postdoctoral Research Fellows conduct research studies in the fields of epidemiology, infectious diseases, immunology or vaccinology within the context of TB vaccine research. Daily responsibilities include co-ordinating clinical vaccine trial implementation and delivery of scientific outcomes and reporting study data, as well as supervising student projects.
Doctoral students conduct novel research studies in the fields of epidemiology, infectious diseases, immunology or vaccinology within the context of TB vaccine research, impacting content of grant applications and protocol development.
SATVI’s academic research team is supported by highly skilled operations, administration, communications, regulatory affairs, information technology, data management and statistics, professional development and quality assurance teams.
The Support teams work closely with the various studies but function independently from study staff. They comprise of dedicated professionals who are specialists in their areas in addition to being well versed and knowledgeable in international and national clinical research regulations and guidelines.
The Clinical Quality Control team ensures that all processes contributing to the performance of a clinical trial are conducted within the structures of the SA GCP; ICH GCP guidelines and other relevant regulations. The main focus of this team is in the clinical domain, with ongoing liaison and co-ordination with the quality management team in the laboratory to ensure the maintenance of an integrated Quality Assurance system within SATVI.
In addition, the PDP team provides a generic clinical research training service to SATVI staff and other organisations as required.
Regulatory affairsThe Regulatory Affairs team provides a service to the SATVI research community regarding the overall ethical management and other regulatory matters relating to research studies.
The Information Technology (IT) team is responsible for the overall management of information, communication and technology within SATVI. This includes the development and maintenance of a robust IT infrastructure and the provision of an efficient IT support service.
Laboratory Operations & Quality Assurance
The Laboratory Operations and Quality Assurance team are responsible for maintaining the integrity of study goals in relation to clinical laboratory science. The service includes overall management of the laboratory sites and equipment, clinical laboratory staff, assurance of laboratory results, consultation regarding the implementation of laboratory procedures pertaining to clinical vaccine trial and research study outcomes. This team is also responsible for the establishment and maintenance of an optimal quality management system for the laboratory.
Data and StatisticsThe Data and Statistics team are responsible for the management of a clinical research data management system, to ensure the quality of data through up front analysis and modelling, design of a robust data infrastructure, continual monitoring of data and statistical analysis. The team further provides data and statistical training support to SATVI staff.
Site Operations and Administration
The Site Operations and Administration support team provides a strategic and operational service to the research sites by directing the development of operational systems, infrastructure development and maintenance, general administration and local stakeholder interactions with the research site.
The Laboratory Team is responsible for laboratory outcomes of clinical vaccine and research studies according to the research design and protocol. The team consists of technologists located both at the study site (Worcester) and in Cape Town, and is supported by the Laboratory Operations support team headed by the Laboratory Project Manager.
TechnologistsThe Technologists are responsible for the performance of laboratory procedures in support of specific clinical vaccine and research studies.
The Laboratory Assistant is responsible for the maintainance of the laboratory facilities and support of laboratory staff as required.
The SATVI Field Team is responsible for the implementation of research studies according to the research design and protocol. The team consists of a broad range of staff, including Pharmacists, Co-ordinators, Research Nurses, Clinical Research Workers, Surveillance Administrators and Project Secretaries.
PharmacistsSATVI Pharmacists are responsible for the co-ordination of all aspects of drug keeping for participants enrolled in clinical trials, ensuring compliance with Good Pharmacy Practice (GPP) and Good Manufacturing Practice (GMP) They are also responsible for counseling participants regarding trial medication, monitoring compliance and adverse effects, as well as liaising with clinical staff regarding participant care.
The Co-ordinators are responsible for all on-site project co-ordination activities associated with the efficient collection of data.
Project senior secretaries
Project Senior Secretaries are responsible for project specific administration.
Research Nurses are responsible for the recruitment, clinical care and management of the trial participants, through the application of nursing skills.
Research Professional Nurses
Research Enrolled Nurses
Research Nursing Assistants
Clinical Research Workers
Clinical Research Workers are responsible for the recruitment, follow-up and retention of trial participants.