Karen Cloete

Experience

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  Boland Therapy and Learning Centre

  Jan 1998 - Jan 2002

  Occupational Therapist

  Private Practice assisting children with learning and development disabilities

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  Shoprite

  Jan 2002 - Dec 2007

  Buyer
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  Quintiles

  Jan 2008 - Aug 2010

  CRA
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  TASK Applied Science

  Sept 2010 - Sept 2017

  Managing the Quality Assurance Department (Clinical)Managing company quality management system across sitesManaging protocol conduct across sites across various trials Managing the link between clinical - and laboratory teamDevelop standard operating proceduresEvaluate current policies and systems for effectiveness Implement and review corrective and preventative actionsQA reporting on clinical trial progressMember of the TBTC Executive Committee (IQC)Member of the TBTC/ACTG Quality Assurance Working GroupAccredited GCP course provider Trainer@ TASK Academy Show less

  • Head of Quality Assurance

    Jun 2016 - Sept 2017

  • Quality Manager

    May 2013 - Jun 2016

  • Quality and Training Coordinator

    Sept 2010 - May 2013

  • Internal Monitor

    Sept 2010 - Dec 2011
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  TASK

  Sept 2017 - now

  Head - Quality, Regulatory and Academy

  GCP and regulatory compliance audits Sponsor initiated trial conduct and compliancy auditsSite audit readiness assistance Site selection visits Clinical Trial Project Management Risk Management Protocol AnnalysisStudy start-up activitiesSAHPRA submission coordination and communication Ethics submission coordination and communicationTeam managementSponsor communicationSite Initiation Visit Coordination and presentations Training

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  TASK Research Academy

  Feb 2021 - now

  Director

  Working with a team of experienced Learning Designers and subjects matter experts we create immersive and engaging learning experiences to help build capacity in the clinical research industry. We also develop simulation materials according to the sponsor and CROs specific needs to enhance their inhouse training programs.