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Experiences

Current Experience

  • National study coordinator UZ Leuven
    Since December 2016

    As a national studycoordinator I'm responsible for the start-up of pediatric academic and commercial trials within UZ Leuven at the pediatric hemato onco service. I' m the team responsible of the team of pediatric hemato-onco studycoordinators. Besides my work for UZ Leuven I also work for the coordination cell of a Belgian society to start-up and implement interantional academic trials within Belgium. This involves funding applications, preparation of all necessary documents for submission to authorities and Ethics committee, communication with international sponsor, follow up on contract and budgets.

Past Experience

  • Study coordinatoor UZ Leuven
    January 2008 --- December 2016

    As a studycoordinator at the Hematology department in UZ Leuven I was responsible to run mainly commercial clinical trials. Follow up start-up process, implementation of the clinical trial after initiation, completing CRFs, queries, SAEs, communication with the sponsor/CRO and the CRA. Besides this clinical work I was also involved to start-up a database (CRF) for the collection of data within Belgium.  I processed the data which resulted in a publication.

  • scientific collaborator Brussels
    March 2001 --- December 2007

    As a scientific collaboration in UZ Brussels at the fertility/genetics department I was responsible for the the implementation of Preimplantation genetics diagnosis (PGD) aneuploidy screening on embryos with Fluorescent in situ hybridisation (FISH) for couples undergoing an IVF treatment that suffered from recurrent miscarriages or X-linked diseases. Besides this clinical work, I was also involved in research activities in this field. 

  • Clinical Research Associate (CRA) Brussels, Belgium
    September 2000 --- February 2001

    As a clinical research associate I was responsible for the start-up and monitoring of clinical trials.

Personality

Self Assessment :
CommunicativeAttention to detailCollaborationInterest in knowledgeFlexibilityCoordinationApproachability

Knowledge

Self Assessment :
Start-upsStudy CoordinationApplicationsBiomedical SciencesBudget ManagementBudgetsClinical Data ManagementClinical trial managementClinical trial budgetingClinical trialseCRFElectronic Data Capture (EDC) Good Clinical Practice (GCP)Informed Consent DocumentsInternational Project ManagementIVRSMedical oncology PediatricsRegulatory submissions

Skills and Expertise

Self Assessment :
Interact with physiciansAdminister, maintain and co-ordinate the logistical aspects of clinical trialsCommunicate with investigatorCommunicate with sponsorConduct studiesEthics committee submissionsFollow up projectsInitiate clinical trials Interact with ethics committeeInteract with physiciansLead studiesSet up a clinical studySubmit regulatory applications

Education

  • Master in Biomedical Sciences from Free University Brussels in 2000

Training and Certification

  • Junior CRA in 2000 Training
  • Project manager in 2000 Training
  • GCP in 2016 Certification
  • up to date e-CRF trainng in 2016 Certification
  • IATA in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    80%-100% FTE
  • International:
    Yes

Area / Region

Mechelen, België

Others

Driving License
  • Yes