Hoi Fen Chong

Study Coordinator at Info Kinetics
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Contact Information
us****@****om
(386) 825-5501
Location
Penang, Malaysia, MY
Languages
  • English -
  • Malay -
  • Chinese (Simplified) -

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Credentials

  • Good Clinical Practice
    Clinical Research Centre, Ministry of Health, Malaysia
    Apr, 2013
    - Oct, 2024

Experience

  • Info Kinetics
    • Malaysia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Study Coordinator
      • Jan 2012 - Present

      Job Description & Responsibilities: 1. Conducting, coordinating and planning of bioavailability / bioequivalence and phase 1 clinical trial studies with ICH-GCP certified. 2. Managing monitoring visits, audits and inspections by Sponsors/Monitors (local and overseas), CRO and regulatory authorities. Handling inspection by National Pharmaceutical Control Bureau (NPCB) and U.S. Food and Drug Administration (USFDA). Dealing with queries from internal and external audit. 3. Develop, reviewing and maintain study documents, e.g. study site/master file, case report forms (CRFs), subject medical notes and other source documents. Ensure that the rights, safety and well-being of study subjects are protected. 4. Develop, implement and improve quality control process throughout the conduct of study. Writing and review Standard Operating Procedures (SOP). 5. Managing submissions for study approval / close-out to National Medical Research Register (NMRR) and Medical Research and Ethics Committee (MREC). 6. Managing submission for regulatory approval to National Pharmaceutical Control Bureau (NPCB) and importation of clinical trial medication e.g. Clinical Trial Import License (CTIL). Show less

  • BP Clinical Lab Sdn Bhd
    • Senior Medical Laboratory Technologist (Senior Executive)
      • Nov 2009 - Nov 2011

      Diagnostic Centre (DC) Manager / Person In Charge of outlet at Perlis state - provided health screening and general report consultation - responsible for sales and collection performance of outlet - ensure smooth running operation Diagnostic Centre (DC) Manager / Person In Charge of outlet at Perlis state - provided health screening and general report consultation - responsible for sales and collection performance of outlet - ensure smooth running operation

  • Pathology & Clinical Laboratory (M) Sdn Bhd
    • Junior Medical Laboratory Scientist
      • Oct 2007 - Nov 2009

      Placed at Enzyme Immuno Assay (EIA) Department, major handle blood test in: - Helicobacter pylori - Human Immunodeficiency Virus (HIV) - Hepatitis B antigen and antibodies Placed at Enzyme Immuno Assay (EIA) Department, major handle blood test in: - Helicobacter pylori - Human Immunodeficiency Virus (HIV) - Hepatitis B antigen and antibodies

Education

  • Universiti Malaysia Terengganu
    Bachelor of Science (Biological Sciences), Microbiology, Tissue Cellular Culture, Biochemistry, Biology Organisms, Molecular Biology
    2004 - 2007
  • Kolej Sultan Abdul Hamid
    Sijil Tinggi Persekolahan Malaysia (STPM)
    2002 - 2003
  • SMK St. Michael
    Sijil Pelajaran Malaysia (SPM)
    1997 - 2001

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