Marcel Potgieter

Experience

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  Steve Biko Hospital

  Jun 2015 - Nov 2020

  Critical Care Clinical Technologist

  As a Clinical Technologist who has specialised in Critical Care I play a significant role in clinical investigative procedures as well as corrective and therapeutic procedures on patients, in collaboration with medical practitioners. I make use of advanced, specialised electro-physiological equipment and other appropriate apparatus and techniques. I have gained experience in patient care by being exposed to ICU, HC, EU and ward patients. I have worked on many advanced specialized equipment ( Hemodynamic devices (Vigileo, EV1000, LIDCO etc) Ventilation (SIV, PPV, CMV, NIPPV etc) and other oxygen therapy devices, I manage, order and maintain medical stock/consumables, I have given numerous training sessions to students, Doctors and nursing staff, I have assisted with clinical studies, collection of laboratory samples as per SOP, protocol and GCP guidelines, I am also experienced in performing advanced coagulation studies on blood samples using specialized equipment and assisting with data capturing and analysis thereof. Show less

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  Tshwane University of Technology

  Apr 2018 - Dec 2019

  Clinical Technology Btech Mentor

  Oversee and assist clinical Technology students with their Btech final research proposals, literature reviews, patient case reports and final research articles. Oversee student progress, provide support where needed and provide assistance with the submission of documents to the relevant Ethical Committees involved.

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  PSI CRO AG

  Nov 2020 - Jun 2023

  Scope of responsibilities:Maintenance of study-specific and corporate tracking systems at site level;ensuring ongoing evaluation of quality at site level; facilitation of site budgetsand contract negotiations; management of investigator site payments; actingas the main line of communication between the Sponsor and the site; buildingand maintenance of good rapport with the site staff involved in the conduct ofthe study; preparation, conduct, and reporting of site selection, initiation,routine monitoring, and close-out visits; patient enrollment monitoring;ensuring accurate and timely reporting and follow up of AE/SAE and protocoldeviations; performance of source data verification and follow up on dataqueries at site level; review of Risk Based Monitoring related informationinfluencing data quality and frequency of site visits; ensuring proper handling,accountability, and reconciliation of all IP and clinical study supplies; review ofthe status and contents of essential documents; reconciliation of studyOSF/TMF at site level; facilitation of the documents and laboratory suppliesflow; support in preparation of draft regulatory and ethics committeesubmission packages; support in collection of IP-REDS packages at site/countrylevel; project specific training of investigators; participation in client onsitevisits Show less Maintenance of study-specific and corporate tracking systems at site level; ensuring ongoing evaluation of quality at site level; facilitation of site budgets and contract negotiations; management of investigator site payments; acting as the additional line of communication between the Sponsor and the site; building and maintenance of good rapport with the site staff involved in the conduct of the study; preparation, conduct, and reporting of site selection, initiation, routine monitoring, and close-out visits; patient enrollment monitoring; ensuring accurate and timely reporting and follow up of AE/SAE and protocol deviations; follow up on data queries at site level; review of Risk Based Monitoring related information influencing data quality and frequency of site visits; ensuring proper handling, accountability, and reconciliation of all IP and clinical study supplies; review of the status and contents of essential documents; reconciliation and preparation of studyOSF/TMF at site level; facilitation of the documents and laboratory supplies flow; support in preparation of draft regulatory and ethics committee submission packages; support in collection of IP-REDS packages at site/country level; project specific training of Investigator’s. Providing support and back up to primary CRA. Co-monitoring visit attendance with primary CRA on-site (visits include SSV, SIV, RMV, COV, motivational visits). Show less Assistance with organization of internal team meetings under supervision; assistance with translations under supervision; administrative assistance with feasibility research under supervision; exchange of data, documents, and other project relevant information between investigative sites, site vendors, project team, and other departments under supervision; support of CA submissions and notifications under supervision; assistance with clinical supplies flow under supervision; assistance with preparation and follow-up of site, TMF, and systems´ audits and inspections under supervision; assistance with handling administrative financial tasks under supervision; preparation of draft minutes of internal team meetings under supervision; assistance with preparation, attendance, and follow-up of Investigator’s Meeting under supervision; maintenance of study-specific and corporate tracking systems under supervision; maintenance of TMF under supervision; TMF review and oversight at country and site level under supervision; preparation, distribution, and update of OSF and OSF checklists under supervision; providing miscellaneous administrative project support. Show less

  • Clinical Research Associate

    May 2022 - Jun 2023

  • Site Administrator/ in house CRA

    May 2021 - May 2022

  • Clinical Trial Administrator

    Nov 2020 - May 2021
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  Speciality Critical Care (Pty)Ltd

  Nov 2020 - May 2022

  Critical Care Clinical Technologist
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  The George Institute for Global Health

  Jul 2023 - now

  Clinical Research Associate