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Paul MOURLHOU

BRUXELLES

En résumé

Clinical Research Coordinator & Lab Technician: 15 years experience


- QA Auditor (clinical and non-clinical studies)
- Overall management of Clinical Trials phase II - IV
- Certification for ICH-GCPs and IATA regulation. Trained for ICH-GMPs, ICH-GLPs
- Lab Technologist for laboratories activities R&D, QC

Mes compétences :
Essais cliniques
Recherche clinique
Génétique
Virologie
Parasitologie
Pédiatrie
Culture cellulaire
PCR
Elisa

Entreprises

  • Zoetis - QA Auditor

    2016 - maintenant • QA Auditor – ZOETIS (Formerly Pfizer Animals Health) - Zaventem, Belgium (2016 - present)

    Part of the Veterinary Medicine Research Development and Global Quality and Compliance Unit, my main tasks were to:

    - Audit of clinical Studies according to VICH-GCPs and pre-clinical studies
    - Provide QA support to the EU clinical development team
    - Participation in a variety of QA-related activities including staff and project meetings, non-study document reviews
  • Queen Fabiola Children's University Hospital (HUDERF) - Study coordinator / CRA

    2013 - maintenant My main task involves coordinating the pediatrics clinical trials conducted at HUDERF (Clinical Trials Phase II, III, IV):
    - Timeline tracking, reports to sponsor and overall management of clinical site (Information and Consent Form, Case Report Forms and e-CRFs filling, SAEs reporting and follow-up)
    - Support to investigators and supporting subjects’ recruitment including vitals signs and EEG assessment
    - Biological samples processing according to protocol and GLP including the shipment of samples to centralized laboratories
    - Protocol and regulatory documents review and regulatory submissions for the studies sponsored by HUDERF
  • Inserm - Information scientist - Expert Resources Database

    PARIS 13 2012 - 2012 Orphanet is the reference portal for information on rare diseases and orphan drugs. My main tasks were to:

    - Identify the sources of information on diagnostic tests, on-going research projects from basic research to clinical trials, registries and biobanks
    - Validate the collected data by national teams (40 countries) in the Orphanet database
  • Inserm - Senior Clinical Research Associate

    PARIS 13 2008 - 2011 The Clinical Investigation Center (CIC) is specialized in infectious, emerging and genetic diseases in tropical areas. My main responsibilities involved:
    - Management of prospective multi-center studies in genetics and infectious diseases (HIV, dengue virus, hepatitis B, HPV)
    - Support to investigators and supporting patients’ recruitments, CRFs and eCRFs filling, SAEs reporting and follow-up
    - Project development and start up process including study organization with the principal investigator, protocol and regulatory documents review and regulatory submissions
    - Coordination of monitoring activities including team training, trip reports and correspondence review, planning supervision, site issues resolution
    - Acting as reference point for the Biological Resource Center of Martinique (CeRBiM)
  • Inserm - Clinical Research Associate

    PARIS 13 2006 - 2008 - Management of multi-center studies in the research field of HIV (Phase III and IV) sponsored by the French AIDS Agency
    - Oversight of all aspects of biomedical research: design of protocols, data collection forms and patient information
    - Monitoring activity: Initiation visits, monitoring visits, close-out visits, tracking of patient enrolment and CRFs, management of SAEs and reporting to sponsor, interactions with data management for data clarifications and database management
  • Assistance publique - Hôpitaux de Paris - Medical Laboratory Technologist

    Paris 2000 - 2005 LABORATORY RELATED PROFESSIONAL EXPERIENCE
    • Medical Laboratory Technologist (2003 – 2005)
    Parasitology and Mycology Laboratory - Hôpital Tenon (AP-HP) - Paris, France
    • Medical Laboratory Technologist (2000 – 2003)
    Hematology, Immunology and Hemostasis Laboratory - Hôpital Rothschild (AP-HP) - Paris, France

Formations

  • Biopark Formation -ULB (Gosselies)

    Gosselies 2015 - 2015 4 months specialization in R&D, QC, QA (08/2015 - 12/2015):
    ELISA, PCR, WB, SDS-Page, FACS, QC microbio, cell culture (HEK-293, CHO, HT29) and transfection
    GMPs and BPLs training,
  • ADDS (Boulogne Billancourt)

    Boulogne Billancourt 2005 - 2005 Clinical Research Associate
  • IFTAB

    Paris 1996 - 1999 DETAB
  • Lycée De Montgeron

    Montgeron 1992 - 1995 Bac Scientifique

Réseau

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