Karen Cloete

Karen cloete

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location of Karen CloeteCity of Cape Town, Western Cape, South Africa
Phone number of Karen Cloete+91 xxxx xxxxx
Followers of Karen Cloete4000 followers
  • Timeline

    Jan 1998 - Jan 2002

    Occupational Therapist

    Boland Therapy and Learning Centre
    Jan 2002 - Dec 2007

    Buyer

    Shoprite
    Jan 2008 - Aug 2010

    CRA

    Quintiles
    Sept 2010 - Sept 2017

    Head of Quality Assurance

    TASK Applied Science
    Bellville
    Sept 2017 - now

    Head - Quality, Regulatory and Academy

    TASK
    Current Company
    Feb 2021 - now

    Director

    TASK Research Academy
  • About me

    Director Task Research Academy, Head Quality Assurance @ TASK | GCP, Risk Management, Clinical Trial Project Management, Clinical Research Training Development and Education

  • Education

    • Stellenbosch high

      1992 - 1993
      High school
    • Waterkloof high

      1989 - 1991
      High school
    • Stellenbosch university/universiteit stellenbosch

      1994 - 1997
      Bachelor’s degree occupational therapy/therapist
  • Experience

    • Boland therapy and learning centre

      Jan 1998 - Jan 2002
      Occupational therapist

      Private Practice assisting children with learning and development disabilities

    • Shoprite

      Jan 2002 - Dec 2007
      Buyer
    • Quintiles

      Jan 2008 - Aug 2010
      Cra
    • 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
    • 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

    • 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.

  • Licenses & Certifications

    • Risk-based quality management essentials.

      Cyntegrity | data science for clinical trials
      May 2023