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Summary

I am a registered nurse with experience as CRA, Clinical Trial Nurse, in Clinical Data Management, Market Acces & Health Economics and CRM software.

Experiences

Current Experience

  • Clinical Research Associate (CRA)
    Since January 2016

    I have over 9 years of experience in Pharma & medical devices.

    I started as a Clinical Trial Nurse (outsourced) and worked within different therapeutic area's such as oncology, Pulmonary diseases and pediatrics. After three years I made a switch to Clinical Data Management. I had a one year project as Jr Clinical Data Manager in a Biotech company. After this project I had the chance of working with a small service provider in Market Acces & Health economics. I also replaced an internal CRM database coordinator during 6 months.

    As of January 2016 I started working as CRA in a Medical Device CRO until October 2016 when I made the switch to a provider who outsources me as a CRA to a Top pharmacompany near Brussels. I am currently involved in a phase 4 observational trial in cardiology.

Personality

Self Assessment :
Attention to detailCuriosityAuthenticitySelf-confidenceCharmCollaborationCoordinationFlexibilityProblem solvingEfficiencyInterest in knowledgeKindnessAssertivenessAdaptabilityApproachabilityWillingness to compromiseTrustResiliencyOrganizationOptimismSociability

Knowledge

Self Assessment :
TeamworkPatient Screening and RecruitmentoncologyMultiple dose tolerance studyMicrosoft OfficeMicrosoft ExcelMedical DevicesMarket accessLife SciencesPatient Follow UpPhase IPhase IIRespiratoryRandomization and blindingR&DProtocolProblem SolvingPowerPointPhase IVPhase IIIICH-GCPHealthcare industryHealthcareData AnalysisCoachingClinical trialsClinical Study DesignClinical researchClinical Data Management (CDM)ClinicalCancerData entryData ManagementDatabase design and maintenanceGood Clinical Practice (GCP)GCPFrenchPrinciples and ethics of clinical researchEnglishElectronic Data Capture (EDC) dutchDesigning case report formsBiotechnologyCDISC Phase I Medical devicesData cleaningEDCICH GCP guidelinesoncoPulmonary diseasesQuality of Life (QoL) outcomesRegulatory submissionsSafety trialsSerious Adverse Event (SAE)Pharmaceutical IndustrySearch literature on clinical trialsRandomization SystemsPhases of clinical development (phase I to IV)Medical writingISOClinical monitoringFiling

Skills and Expertise

Self Assessment :
Design case record forms Guide students Interact with nurses Interact with physicians Report dataAdministrative supportArchive documentationAdverse event reportingCoach staffCommunicate with investigatorClinical data collectionCollaborate with principal investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresConduct the trialCollect patient forms and questionnairesData codingData entryData verificationDesign case record form (CRF)Design data reporting systemsEnsure good clinical practice (GCP)Manage clinical trial files/documentsPatient recruitmentReview exclusion criteriaRegulatory documentationReview quality control activities

Education

  • Bachelor in Nursing from KHLeuven in 2009

Training and Certification

  • CRA training in 2016 Training
  • ICH-GCP in 2015 Certification

Languages

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

Work Preferences

  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Flemish brabant

Others

Driving License
  • Yes