Jabulisiwe Lethabo Maphanga

• 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.

• 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.

• General office Admin
• Facilitate Prize Payments to National Lottery Winners timeously and professional.
• 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.

• 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

• 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 Pre and Post Test counselling

Group education

• Responsible for Conducting Pre and Post Test Counselling
• Group education .