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Positive, motivated and dynamic Biomedical Scientist with previous experience in clinical trials (study coordinator, study start-up specialist and medical affairs associate) is looking for a new challenge as a Clinical Research Associate.

Experiences

Current Experience

  • Advisor Clinical Trials


    Since October 2018
    Ethics

    Temporary replacement. 

    Evaluation of submission packages to the Ethics Committee (academic trials)

    Contracts: set-up + finalization

Past Experience

  • Travel

    December 2017 --- September 2018

    Travelled in South-America for 10 months. 

  • Medical Affairs Associate

    June 2017 --- December 2017
    Project Management

  • Study Start-up Specialist

    May 2015 --- December 2017
    Ethics

  • Clinical Research Nurse

    November 2012 --- June 2014
    Patient Recruitment

  • Research associate

    October 2011 --- October 2012
    Career

Personality

Self Assessment :
ProactivityAdaptabilityAssertivenessAttention to detailCoordinationEfficiencyIndependenceOptimismProblem solving

Knowledge

Self Assessment :
Diabetes Scientific writingCardiologyClinical Data Management (CDM)Clinical trialsData entryElectronic Data Capture (EDC) Endocrinology and metabolismEndocrinologyEthics submission and approval processGCPHospitalsICH GCP guidelinesInformed Consent ProcessPatient Screening and RecruitmentPhase IIIPhase IVPowerPointProtocolSearch literature on clinical trialsSerious Adverse Event (SAE)Informed Consent Documents

Skills and Expertise

Self Assessment :
Analyze data Control data Interact with nurses Interact with physicians Search literature on clinical trials Write papersAdverse event reportingCapture data on source documentsClinical data collectionCollaborate with principal investigatorCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Conduct the trialContact potential subjectsControl dataCoordinate with the ethics commiteeCreate study documentsData entryDocument adverse eventsEnsure data consistencyEnsure good clinical practice (GCP)Ethics committee applicationEthics committee submissionsFacilitate sponsor monitoring visitsInitiation visitPatient recruitmentPlanning clinical studiesScreen patients

Education

  • Master in Biomedical Sciences from Ghent University in 2011

Training and Certification

  • Good Clinical Practice in 2013 Certification
  • Trained DXA and pQCT professional in 2013 Certification

Languages

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

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    FTE (100%)% FTE
  • International:
    Yes

Area / Region

België

Others

Driving License
  • Yes

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