Jabulisiwe Lethabo Maphanga
Overview
23
23
years of professional experience
Work History
Quality Control/Assurance Officer
CAPRISA
11.2016 - Current
- Assisting Study Coordinator in Preparing and submitting documents to IEC/IRB and other regulatory bodies.
- Review of SOP’s, source documents and training of staff
- Assist study Coordinator in maintenance of ISF.
- Data verification - QC and QA.
- Preparing for site monitoring visit.
- Data Management
- Compiling Data Report
- Data Capturing
- Resolving Database Queries
- Ensure 100% review of ICFs
- Filing Consent Forms / Diary Card/Memory Aids
- Filing participants files
- Compiling Retention Stats
- PID allocation
- QC1 and QC2 of participants files
- CAPA report from internal and external monitors
- Assist Finance with monthly Database report for reconciling.
Quality Assurance Officer
WITS RHI
06.2016 - 11.2016
- Assist Regulatory Compliance Manager with QA of Regulatory files
- Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
- Ensure errors on CRF’s are corrected as per GCP guidelines
- Support the timely transmission/data of relevant Case Report Forms following QC activity (as needed)
- Ensure completion of corrective action of internal and QC reports/error trends identified during QC
- Coordinate staff training (and retraining) where error trends are identified
- QC of Informed Consent and other source documents to ensure accuracy and completeness
- Support Regulatory Manager with periodic quality assurance activities as per the CQMP
- Compile QA/QC reports on findings for site meeting.
KZN Regional Office Administrator
National Lottery (Gidani)
01.2011 - 06.2015
- General office Admin
- Facilitate Prize Payments to National Lottery Winners timeously and professionally.
- Ensure that all administration related to Winner’s Payments is conducted and recorded as per Policies and Procedures of GIDANI.
- Processing of Walk-in Winners Prize Pay-outs – Receive Winners and take them through the Prize Claim Process while ensuring strict adherence to GIDANI’s Policies and Processes up to the actual processing and finalisation of Prize Payment.
- Audit the Winner’s information and ensure full completion of forms and ensure follow-ups where necessary.
- Capture and update the Winner’s information accurately on Excel
- Maintain a proper filing system for all Retailer files and update timeously
- Handle telephonic and walk-in winners’ queries.
- Order and manage stationery for Regional Office
- Ensure all office equipment is functional
- Manage petty cash
- Maintain a clear channel of communication between Gidani and its stakeholders
- Maintaining HR files for KZN site
- Support 10 Field Marketing Executives to process their orders.
- Weekly courier documents to Head Office
- Ensuring acceptable working environment for staff e.g., fire extinguishers serviced on time, enough sanitary, first aid kit etc.
- Preparing and typing documents
- Ordering of office supplies
- Compiling monthly reports and stock count.
- Assist finance in collecting outstanding monies from retailers.
Regulatory Administrator
Medical Research Council (TB Unit)
06.2008 - 01.2011
- Preparation and submission of protocol amendments to BREC and MCC/SAHPRA
- Registering our studies with South African National Clinical Trial register- SANCTR/NHREC
- Assist in study recertification application
- Quality control on patient files
- CAPA reports
- Maintaining site investigator files
Data Coordinator
MRC (HIV PREVENTION UNIT)
09.2007 - 12.2007
- Data Management at site level
- Compiling Data reports
- Responsible for weekly and daily data backup
- Data faxing Case Record Forms
- Addressing QC report from external Data management
- Compiling staff roster
- Uploading of study files on ACASI Study website
Research Assistant
MRC (HIV PREVENT UNIT)
07.2004 - 09.2007
- Participants reimbursement
- Reminding participants of their next scheduled visits
- Conducting and obtaining consent forms
- Filing Lab results
- Addressing QC queries from Data Management
- Preparing participants files
HIV /AIDS COUNSELLOR
AFRICA CENTRE for Population Studies
06.2003 - 07.2004
HIV /AIDS COUNSELLOR
AFRICA CENTRE for Population Studies
06.2002 - 07.2003
Education
BA - Community Development
University of South Africa
01.2021
3 Years National Diploma - Information
Durban Computer College
01.2000
National Senior Certificate - Exemption Pass
Umfolozi High School
01.1997
Skills
- Microsoft Office skills
- Data collection
- Data capturing
- Electronic Data Capturing
- Quality Control
- Quality Assurance
- ICH GCP
- SA GCP
- Regulatory submission
- Regulatory tracking
- Onsite monitoring preparation
- Interpersonal skills
- Communication skills
- Database management
References
- Dr Thesla Palanee (PhD), Head of Network Trials, Research Centre Wits Reproductive Health (Wits RHI), +27113585471, +27837833574, tpalanee@wrhi.ac.za
- Peter Mundalamo, Gauteng Regional Manager, South African National Lottery, p.mundalamo@gidani.co.za, 0835665071
- Dhineshree Govender, CRAII at IQVIA, dhineshree.govender2@iqvia.com, 0827803020
- Mahlori Mkhabele, Clinical Assessor at SAHPRA, Mahlori.mkhabele@sahpra.org.za, 0815246267 / 0837475204
- Dr Razia, Research Clinician, CAPRISA, Razia.Hassan-Moosa@caprisa.org, 0834681200
- Ntombifuthi Zwane, Senior CRA at ICON PLC, futhi.zwane@iconplc.com, 0736296201
- Pinky Motsomi, Study Coordinator, CAPRISA, pinky.motsomi@caprisa.org, 0670310098
Training
Virtual Study Coordinator Training - Delivering a Successful Clinical Study: A Roadmap for Study Coordinators, 06/01/21, Siara Limited: Clinical Research Training and Consultancy
Personal Information
- Date of Birth: 04/01/79
- Gender: Female
- Nationality: South African
Clinical Trials
- IMPROVING RETREATMENT SUCCESS (IMPRESS), CAP011, Quality Control Officer
- The Correlate of Risk Targeted Intervention Study (CORTIS-01). A Randomized, partially blinded, Clinical Trial of Isoniazid and Rifapentine (3HP) Therapy to Prevent Pulmonary Tuberculosis in High-risk Individuals Identified by a Transcriptomic Correlate of Risk., CORTIS-01, Quality Control Officer
- Validation of correlates of risk of TB disease in high-risk populations (CORTIS-HR) – A Companion Study of the CORTIS-01 Trial., CORTIS-HR, Quality Control Officer
- A randomized, placebo-controlled, observer-blind, phase 2 study to evaluate safety and immunogenicity of the investigational M72/AS01E Mycobacterium tuberculosis (Mtb) vaccine in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus (HIV)., Gates MRI TBV02-202, Quality Control Officer
- A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy Safety, and Immunogenicity of BCG revaccination in Healthy Adolescents for the Prevention of Sustained Infection with Mycobacterium tuberculosis., Gates MRI TBV01-201, Quality Control Officer
- A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB A multi-centre, multi-country prospective cohort study., CAP094
- The Individualized M (X) drug-resistant TB Treatment Strategy Study., CAP020, Quality Control Officer
- Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults., Gates MRI-TBV02-301, Quality Control Officer
Timeline
Quality Control/Assurance Officer
CAPRISA
11.2016 - Current
Quality Assurance Officer
WITS RHI
06.2016 - 11.2016
KZN Regional Office Administrator
National Lottery (Gidani)
01.2011 - 06.2015
Regulatory Administrator
Medical Research Council (TB Unit)
06.2008 - 01.2011
Data Coordinator
MRC (HIV PREVENTION UNIT)
09.2007 - 12.2007
Research Assistant
MRC (HIV PREVENT UNIT)
07.2004 - 09.2007
HIV /AIDS COUNSELLOR
AFRICA CENTRE for Population Studies
06.2003 - 07.2004
HIV /AIDS COUNSELLOR
AFRICA CENTRE for Population Studies
06.2002 - 07.2003
BA - Community Development
University of South Africa
3 Years National Diploma - Information
Durban Computer College
National Senior Certificate - Exemption Pass
Umfolozi High School
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