Hi, I’m
Sibekezelo Msomi
Clinical Trial Research
Pretoria,GP
Summary
SUMMARY OF EXPERIENCE
Literature Review
Facilitation of Focus Group Discussions
Data Collection using structured and unstructured methodologies
Qualitative and Quantitative methods of Data Collection
Data Capturing
Quality Control and Quality Assurance
Source Data Verification
Internal Clinical Research Site Monitoring
eCRF Capturing
Data query resolution
Development of Quality Management Systems
Development of Training Plans and Training Materials
Training and Facilitation
SOP writing & review
Report Write Up
Facilitation of CAPAs (Corrective And Preventative Actions) at site
Involvement before, during and after site monitoring, audits & inspections:-
Involvement in activities at site level before, during & after Sponsor Audit
Involvement in activities at site level before, during & after SAHPRA inspection
Involvement in activities at site level before, during & after FDA inspection
SUMMARY OF PROGRAMS WORKED ON
Gender-Based Violence in 4 KZN Rural Areas
Values clarification in public health care sectors (situational analysis)
Orphaned & Vulnerable Children’s Impact Study
Prevention of Mother to Child Transmission of HIV (PMTCT)
SUMMARY OF CLINICAL TRIAL THERAPEUTIC AREAS WORKED ON
HIV prevention (Microbicides), HIV drug resistance and pharmacokinetics trials
HIV prevention (vaginal film and vaginal ring) trials
ARV Treatment Studies
COPD Studies
Rheumatoid Arthritis Studies
Diabetes 1 and 2 Studies
RSV (Respiratory Syncytial Virus) vaccine
HIV Vaccines Clinical Trials
TB vaccine
COVID-19 vaccine
FLU vaccine
Overview
23
years of professional experience
Work History
The Aurum Institute
Quality Regulatory & Data Manager
09.2021 - Current
PHRU
Clinical Research Site & Study Coordinator
12.2019 - 08.2021
PHRU
Senior Quality Assurance Officer
01.2018 - 11.2019
Wits RHI
Regulatory Compliance Officer (HIV Treatment Program)
03.2016 - 12.2017
Synexus
Data Coordinator (Clinical Research)
08.2014 - 02.2016
Synexus
Quality Assurance Officer (Clinical Research)
06.2013 - 07.2014
Wits RHI
Regulatory Compliance Officer (HIV Prevention Program)
02.2012 - 05.2013
MRC
QA/QC officer
10.2009 - 01.2012
UKZN (WHHRU)
Project Coordinator (PMTCT Program - research)
08.2008 - 09.2009
UKZN (WHHRU)
Ethnographer (Prep for PMTCT Program)
06.2007 - 08.2008
NOAH
Monitoring & Evaluation Officer (OVC Program)
04.2006 - 05.2007
RHRU
Junior Project Coordinator
06.2004 - 04.2006
RHRU
Research Assistant
01.2003 - 05.2004
RHRU
Research Intern
05.2002 - 12.2002
Education
Tshwane University of Technology
Post Graduate Diploma from Pharmaceutical Science
01.2024
University of Durban Westville
Bachelor of Arts from Social Sciences discipline
05.2001
Websites
Summary Of Experience
- Literature Review
- Facilitation of Focus Group Discussions
- Data Collection using structured and unstructured methodologies
- Qualitative and Quantitative methods of Data Collection
- Data Capturing
- Quality Control and Quality Assurance
- Source Data Verification
- Internal Clinical Research Site Monitoring
- ECRF Capturing
- Data query resolution
- Development of Quality Management Systems
- Development of Training Plans and Training Materials
- Training and Facilitation
- SOP writing & review
- Report Write Up
- Facilitation of CAPAs (Corrective And Preventative Actions) at site
- Involvement before, during and after site monitoring, audits & inspections
- Involvement in activities at site level before, during & after Sponsor Audit
- Involvement in activities at site level before, during & after SAHPRA inspection
- Involvement in activities at site level before, during & after FDA inspection
Related Courses
- Project Management, Oxbridge Academy, 2021-01-01
- Essential Science Project Management, DNAbiotec, 2019-07-08
- Conducting Research Responsibly, Wits University, 2017-02-01
- Good Clinical Practice (GCP), Academic Advance, 2022-02-01
- Advanced Clinical Data Management, ACRO, 2014-10-20
- Clinical Research Associate (CRA) Course, ACRO, 2014-05-12
Summary Of Programs Worked On
- Gender-Based Violence in 4 KZN Rural Areas
- Values clarification in public health care sectors (situational analysis)
- Orphaned & Vulnerable Children’s Impact Study
- Prevention of Mother to Child Transmission of HIV (PMTCT)
Summary Of Clinical Trial Therapeutic Areas Worked On
- HIV prevention (Microbicides), HIV drug resistance and pharmacokinetics trials
- HIV prevention (vaginal film and vaginal ring) trials
- ARV Treatment Studies
- COPD Studies
- Rheumatoid Arthritis Studies
- Diabetes 1 and 2 Studies
- RSV (Respiratory Syncytial Virus) vaccine
- HIV Vaccines Clinical Trials
- TB vaccine
- COVID-19 vaccine
- FLU vaccine
Own Vehicle
Yes
Personal Information
- Gender: Female
- Driving License: Code 8
Timeline
Quality Regulatory & Data Manager
The Aurum Institute
09.2021 - Current
Clinical Research Site & Study Coordinator
PHRU
12.2019 - 08.2021
Senior Quality Assurance Officer
PHRU
01.2018 - 11.2019
Regulatory Compliance Officer (HIV Treatment Program)
Wits RHI
03.2016 - 12.2017
Data Coordinator (Clinical Research)
Synexus
08.2014 - 02.2016
Quality Assurance Officer (Clinical Research)
Synexus
06.2013 - 07.2014
Regulatory Compliance Officer (HIV Prevention Program)
Wits RHI
02.2012 - 05.2013
QA/QC officer
MRC
10.2009 - 01.2012
Project Coordinator (PMTCT Program - research)
UKZN (WHHRU)
08.2008 - 09.2009
Ethnographer (Prep for PMTCT Program)
UKZN (WHHRU)
06.2007 - 08.2008
Monitoring & Evaluation Officer (OVC Program)
NOAH
04.2006 - 05.2007
Junior Project Coordinator
RHRU
06.2004 - 04.2006
Research Assistant
RHRU
01.2003 - 05.2004
Research Intern
RHRU
05.2002 - 12.2002
Tshwane University of Technology
Post Graduate Diploma from Pharmaceutical Science
University of Durban Westville
Bachelor of Arts from Social Sciences discipline
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