Professor Lynette Denny, Director
Director: SA Medical Research Council Gynaecological Cancer ResearchI am a gynaecologic oncologist and have been working in the field of cervical cancer prevention in collaboration with colleagues from Columbia University, New York since 1995. We began our collaboration with the intention of evaluating alternative strategies for the prevention of cervical cancer in low resource settings. Cervical cancer was and remains the commonest cancer diagnosed among women living in poor countries due to the failure to either initiate or sustain cytology based screening programs. Our group pioneered the search for alternative protocols for the prevention of cervical cancer in community-based research sites in townships just outside of Cape Town.
Since that time I have had extensive research experience in cervical cancer prevention, including three cross-sectional studies comparing different screening tests (such as HPV testing and VIA to cytology), a prophylactic HPV vaccine trial in HIV positive women and a therapeutic vaccine trial in HPV negative women. We are currently engaged in a NCI funded trial evaluating screen and treat with the HPV Xpert Cepheid HPV test. I am still fully functional as a clinician in all aspects of gynaecology oncology and have recently been appointed the director of the SA Medical Research Council Gynaecological Cancer Research Centre, with 5 years of guaranteed funding.
Ms Lavinia Petersen
Project Manager
Lavinia has worked within the Health Sciences Faculty and in clinical research for many years and is experienced in the coordination and management of investigator-led studies and pharma trials (including Phase 1 studies). She has extensive experience in all aspects of Clinical Trial administration and management – from study start up, feasibility, regulatory submissions, site initiation to study close out and archiving of clinical trial documentation. Her training also includes coordination of clinical and field research, assisting with laboratory processes, data management, quality assurance and monitoring. She has a special interest in Regulatory affairs and preparing sites for monitoring and auditing, as well as training and mentoring study staff at various sites in practical aspects of clinical trial coordination and conduct according to GCP guidelines.
She is currently responsible for coordination and management of the GCRC site at Frere Hospital, East London. Responsibilities include regular liaison with the team, remote monitoring of site and study conduct in accordance with GCP principles, providing online training and ensuring site staff are GCP trained. Developing and maintaining project management tools and documents, provide training where necessary, arrange meetings and provide feedback to Director of GCRC.
Review and assist with setting up new databases and overseeing quality data collection in accordance with protocol and SOPs.
Responsible for Regulatory Affairs at GCRC: Preparing and coordinating submissions to Ethics Committees and ensuring GCRC studies have approval from all relevant regulatory bodies. Review and provide oversight for regulatory submissions, including submissions for hospital and provincial approvals.
Coordinating the recruitment, selection of staff and management of HR processes for staff.
Overseeing and sourcing and/or maintenance of equipment and clinical/ scientific supplies necessary for the various trials. Tracking and reporting study status and research outputs and publications to SAMRC (including project metrics and Finance).
Setting up of other collaborating sites of GCRC in the Eastern Cape and monitoring study conduct at sites.
EASTERN CAPE STAFF
Ms Nontuthuzelo Tshabane
Research Nurse
Ms Tshabane is responsible for recruitment and management of participants in all GCRC research studies in
East London Hospital Complex. She is also responsible for reviewing of all gynaecological oncology patient
files and for retrieval of clinical data for the oncology registry.
Miss Ntombiyawo Cebesha
Community Health Worker
Ms Cebesha is our Community Health Worker and she oversees the administrative function and
provides support to the research study.
This entails accurate patient data collection as well as ensuring correct sample numbering for inclusion in to the research study.
The Community Health Worker also ensures daily specimen reconciliation and sample transport to the main hospital. Retrieving of patient files to be used for the retrospective registry.
Mr Manelisi Simunu
Community Health Worker and Data Capturer
Mr Simunu oversees the administrative function and support of the research study. This entails accurate
patient data collection as well as ensuring correct sample numbering for inclusion in to the research study.
The Community Health Worker also ensures daily specimen reconciliation and sample transport to the main hospital. Retrieving of patient files to be used for the oncology registry.
Miss Vuyi Ndabeni
Data Capturer
Ms Ndabeni ensures accurate and regular entry of patient data into the database from information provided
by the clinical notes and other members of the team e.g. pathology, radiology, clinicians with medical results and treatment interventions. She is also responsible for identifying missing information and reports to data manager and clinicians.
She is also responsible for backing up data and transferring data from Eastern Cape sites to GCRC.