Femke Wauters

Clinical Research Associate I at IQVIA Belux
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Contact Information
us****@****om
(386) 825-5501
Location
Brussels Metropolitan Area, BE
Languages
  • Dutch Native or bilingual proficiency
  • French Full professional proficiency
  • English Full professional proficiency
  • Duits Elementary proficiency

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Credentials

  • MDS-UPDRS Training Program & Certificate Exercise
    International Parkinson and Movement Disorder Society
    Jun, 2021
    - Oct, 2024
  • GCP training: how to write a clinical research protocol for a succesful project
    EFGCP -- European Forum for Good Clinical Practice
    Sep, 2020
    - Oct, 2024
  • C-SSRS training
    BlueCloud® by HealthCarePoint.com
    Jun, 2021
    - Oct, 2024
  • BLS/AED
    Centre Hospitalier de Luxembourg
    Mar, 2021
    - Oct, 2024
  • Montreal Cognitive Assessment
    ZIAD NASREDDINE
    Mar, 2021
    - Oct, 2024
  • ICH-GCP
    EFGCP -- European Forum for Good Clinical Practice
    Mar, 2020
    - Oct, 2024
  • Basic Life Support (BLS)
    UZ Brussel
    Oct, 2017
    - Oct, 2024

Experience

  • IQVIA Belux
    • Belgium
    • Hospitals and Health Care
    • 200 - 300 Employee
    • Clinical Research Associate I
      • Sep 2022 - Present

      Outsourced to Lilly. Performing site monitoring visits (initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalating quality issues as appropriate. Show less

  • Labcorp Drug Development
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • In House Clinical Research Associate II
      • Jan 2022 - Aug 2022

      Monitoring the progress of clinical studies (phase I - III, multiple sponsors) remotely & ensure they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP’s), ICH-GCP and all applicable regulatory requirements. Main therapeutic area: oncology. Monitoring the progress of clinical studies (phase I - III, multiple sponsors) remotely & ensure they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP’s), ICH-GCP and all applicable regulatory requirements. Main therapeutic area: oncology.

  • Centre Hospitalier de Luxembourg
    • Luxembourg
    • Hospitals and Health Care
    • 500 - 600 Employee
    • Study Nurse & Clinical Team Collaborator
      • Jan 2020 - Dec 2021

      Study nurse and clinical team collaborator for the Parkinson Research Clinic. I was responsible for patient visits, data management, informed consent, managing study material, administration, flying team, presentations, … I also was responsible for the weekly held Parkinson nursing consultancies where our team supported Parkinson patients in all areas of their life that may be impacted by the disease. We also checked if a medication adjustment was needed in oral medication and with medical devices such as apomorphine & duodopa pump and deep brain stimulation. Show less

  • UZ Brussel
    • Hospitals and Health Care
    • 700 & Above Employee
    • Study Nurse
      • Jan 2019 - Oct 2019

      Study nurse at the diabetic research team: clinical trials in diabetology, neurology, hepatology & gynaecology (phase I - IV). I worked here for 10 months since we then moved to go work abroad in the Grand Duchy of Luxemburg.

    • Nurse responsible for general care
      • Oct 2016 - Dec 2018

      I started my career as a registered nurse in the UZ Brussel hospital. I did most of my internships here as a student and also worked there during my last year in college (oncology daycare service). Thanks to the nursing director I was able to explore different services until I found the area I am most passionate about; clinical research.◦ Cardiovascular surgery nursing unit (30Sep2016 - 30Jul2017)◦ Hemodialysis service (31Jul2017 - 31Dec2018).

  • UZ Brussel
    • Hospitals and Health Care
    • 700 & Above Employee
    • Nurse (summerjob)
      • Apr 2016 - Jul 2016

      Summer job at the oncology day care service (in the easter and summer holiday) in my last year as a student. Main tasks: blood sampling and preparing the access site for chemotherapy (via pricking perfusions, port-a-cath, PICC), phlebotomy for hemochromatosis, blood transfusions, assisting the doctor with bone marrow biopsy and aspiration, ... Helping out wherever I could with other logistic tasks, organisation, … Summer job at the oncology day care service (in the easter and summer holiday) in my last year as a student. Main tasks: blood sampling and preparing the access site for chemotherapy (via pricking perfusions, port-a-cath, PICC), phlebotomy for hemochromatosis, blood transfusions, assisting the doctor with bone marrow biopsy and aspiration, ... Helping out wherever I could with other logistic tasks, organisation, …

Education

  • Odisee
    Bachelor's degree, Nursing

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