Norma Mugwagwa Moyo
Cape Town
Summary
Internal medicine resident with over 5 years of extensive experience in clinical trials as a research physician. Working knowledge of global regulatory requirements, research ethics, FDA guidelines, in-depth knowledge of ICH and GCP and Safety Reporting guidelines. Extensive experience with study start-up processes, trial implimentation and monitoring and the reporting and processing of adverse events from clinical trials.
Overview
13
13
years of professional experience
Work History
Medical Registrar, Internal Medicine
Groote Schuur Hospital, Cape Town
04.2023 - Current
- Diagnosis formulation, investigating and coming up with management and treatment plan for internal medical cases.
- Overseeing treatment of admitted patients and follow up on the ward and/or as outpatient with guidance from consultant physician
- First “on call” for internal medical cases in the emergency department.
- Following up of patients in specialty clinics depending on firm attached
- Clinical teaching of undergraduate MBChB students and training of interns.
Principal Investigator
Ndhlovu Research Centre
12.2021 - 03.2023
- Principal/Sub-Investigator for COVID-19 Vaccine Trials
- Facilitated protocol training of research teams.
- Screened participants for eligibility, enrolment, monitoring and follow up study participants.
- Clinical diagnosis and management and documentation of Adverse Events as required by the protocol. Completion of Serious Adverse Experience (SAE) and Expedited Adverse Event forms in a timely fashion as required by the protocol.
- Oversight and ensuring compliance to study and organizational protocols.
- Ensured that high quality data collection
- Part of the core Clinical Research Site (CRS) management team responsible for site budget development, and provision of leadership and guidance for site staff.
Clinical Research Fellow
Emory University School Of Medicine
01.2012 - 09.2014
- Independently managed significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects.
- Trained and provided guidance to less experienced staff.
- Oversaw data management for research projects.
- Interfaced with research participants and resolved issues related to study protocols.
- Determined effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Periodically audited operations including laboratory procedures to ensure compliance with applicable regulations; provided leadership in identifying and implementing corrective actions/processes.
- Monitored IRB submissions and responded to requests and questions.
- Interfaced with study sponsors, monitors, and reports SAEs; resolves study queries.
- Provided leadership in determining, recommending, and implementing improvements to policies/processes.
- Medical review of adverse drug reactions/adverse event reports
- Assessment of causality, seriousness, and expectedness of adverse drug reactions/adverse event report.
- Ensured compliance with research protocols, reviewed case report forms and audits for accuracy with source documents, attended monitoring meetings with sponsors
- Prepared regulatory submissions with appropriate credentialing and training.
Education
Masters in Internal Medicine - Internal Medicine
University of Cape Town
Cape Town04-2027
Master of Science - Clinical Trials
University of Oxford
Oxford, UK05-2025
Master of Public Health - Public Health
University of Zimbabwe, College of Health Sciences
Harare, Zimbabwe12-2014
MBCHB - Medicine And Surgery
University of Zimbabwe, College of Health Sciences
Harare Zimbabwe04-2010
Skills
- HIV Research- Prevention and Treatment Trials, Protocol implementation- training study staff, recruitment, enrolment, ICF processes, participant follow up, AE reporting and management, Data management, SOP development, QA/QC, Trial monitoring, TMF management, Trial oversight
- FDA guidelines, in-depth knowledge of ICH and GCP and Safety Reporting guidelines
- Clinical Trial protocol design and development
- Sound medical knowledge- diagnosis , treatment and management
- Public Health- Epidemiology, programme implementation and management
- Computer Skills: Microsoft Office Work and Outlook, Word, Power Point, Excel
- Expert use of EDC- MediData Rave, RedCap, Epi Info
- Other- Report writing, Powerpoint presentation
Timeline
Medical Registrar, Internal Medicine
Groote Schuur Hospital, Cape Town
04.2023 - Current
Principal Investigator
Ndhlovu Research Centre
12.2021 - 03.2023
Clinical Research Fellow
Emory University School Of Medicine
01.2012 - 09.2014
Masters in Internal Medicine - Internal Medicine
University of Cape Town
Master of Science - Clinical Trials
University of Oxford
Master of Public Health - Public Health
University of Zimbabwe, College of Health Sciences
MBCHB - Medicine And Surgery
University of Zimbabwe, College of Health Sciences
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