Mahlori Mkhabele

Experience

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  Miami Canners

  Jul 2011 - Sept 2011

  Hygiene Officer/Quality controller

  Quality testing through organoleptic procedures, production line inspection, training unskilled staff in conformance with HACCP and GMP, cleaning inspection auditing, optimisation of cleaning procedures & data trace for core temperatures of products

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  The National Research Foundation of South Africa (NRF)

  Apr 2012 - Mar 2013

  Intern Research Assistant

  Running a project investigating alternative splicing induced by medicinal plants on cancer implicated gene, this includes proposal writing, plant perpetration, extraction of plant phenolics in compliance with Good Manufacturing Practices, treating the variety of cancer cells with the phenolics, extract RNA, run reverse transcription to produce cDNA, clone in Real-Time PCR, sequence possible isoforms and compare within the DNA database for homology.

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  South African Police Service (SAPS)

  Apr 2013 - Dec 2013

  Forensic Analyst
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  Department of Health Free State

  Jan 2014 - Aug 2017

  Medical Natural Scientist/Study Coordinator

  Coordination of trials between site and CRO, patient recruitment, regulating adherence to protocol, SA-GCP and ICH-GCP. Coordination of laboratory tests with laboratories and booking of patient appointments.

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  Wits Health Consortium

  Mar 2019 - Dec 2019

  Research Associate

  Monitoring and evaluation of infection rates; monthly dissemination of results. Data collection tool design, data entry, data analysis & dissemination.

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  CAPRISA

  Jan 2020 - Jun 2021

  Study Coordinator

  Involved in the management and coordination of a CDC-PEPFAR funded Health Systems Strengthening project i.e. Advanced Clinical Care project for HIV patients. The current phase involves research and scientific writing of reports to the sponsor; finalization of training curricula and organization of training for the Master trainers in Advanced Clinical Care (ACC).

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  Wits RHI

  Jul 2021 - Jun 2022

  Regulatory Compliance Officer

  Establish and maintain effective working relationships with all WRHI staff at various levels. Liaise effectively with protocol teams, regulatory authorities, sponsors, CRA’s, monitoring organizations and outsourced laboratories. Create, establish and maintain regulatory systems for WRHI studies per SAHPRA, Wits Health Research Ethics Committee, sponsor and DOH requirements. Support drafting and submissions of technical reports to IRB’s, SAHPRA and sponsors as needed.

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  African Clinical Research Organisation (Pty) Ltd

  Jun 2022 - now

  Regulatory Assistant

  Provide Sponsor perspective regulatory services including submission of regulatory submissions to SAHPRA and Ethics Committees. Monitoring of staff movement and their associated submissions or notifications. Provide support to monitoring team. Manage SANCTR submissions. Update ISF and regulatory documentation in the TMF.