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Summary

Clinical Research Associate with high experience in Medical Devices and cardio-Vascular studies. study Coordinator for more then 6 years for more then 25 cardio-Vascular intervention studies and drug studies in medical center "de klokkenberg" for more then 22 years worked as a icu Nurse on a coronaire care unit.

worked as head of icu department and manager Phase I center for reorganisation of a clinic.

 

Experiences

Current Experience

  • Clinical research Associate

    The Netherlands
    Since March 2016
    monitor for several studies in Cardiology Monitor for several studies in cardiology

  • Consultant

    The Netherlands
    Since December 2015
    perform submissions and monitoring for Biomarker study Perform submissions and monitoring for biomarker study

  • Clinical Research Associate (CRA)


    Since July 2012
    responsible for submission to the ec. central contact person for the european sites. resposible for submission of saes to the ca. monitoring in the netherlands. Responsible for submission to the EC. Central contact person for the European sites. Resposible for submission of SAEs to the CA. Monitoring in the Netherlands.

  • Freelance Clinical Research Associate (owner)


    Since February 2010
    started my own company as Freelance CRA started my own company as freelance CRA

Past Experience

  • Clinical Research Associate (CRA)

    May 2013 --- February 2017
    monitoring for aptiv solutions/iconplc performing monitoring for dr falk studies, medtronic study performed Phase I Clinical monitoring for vessex Pharmaceuticals performed remote monitoring as in-house CRA for terumo

  • Senior Clinical Research Associate The Netherlands

    November 2010 --- February 2017

    working on several projects in Medical Devices in the netherlands and belgium as contract senior CRA

  • Clinical Research Associate (CRA)

    February 2015 --- August 2016
    Clinical Research Associate for cto Cardiology study in the netherlands

  • feasability CTA for InventivHealth

    February 2015 --- August 2015

    performing feasability follow-up for inventivhealth in netherlands, belgium and germany

  • Clinical Research Associate (CRA)

    June 2014 --- November 2014
    late phase monitoring for optum insight

  • Clinical Research Associate (CRA)

    October 2011 --- December 2013
    CRA in the netherlands for outcome studies for msd

  • Clinical Research Associate (CRA)

    July 2013 --- October 2013

  • Clinical Research Associate (CRA)

    June 2012 --- February 2013
    performing monitoring

  • Clinical Research Associate (CRA)

    September 2012 --- November 2012
    CRA for the German market

  • Clinical Research Associate (CRA)

    January 2012 --- July 2012
    monitoring Phase I study for vertex

  • Clinical Project Manager (CPM)

    February 2012 --- May 2012
    performing overview for study start-up for Medical Device pilot trial. reviewing science)" rel="nofollow">Protocol for gcp rules, completing ccmo submission, writing patient information and Informed Consent form

  • Clinical Research Associate (CRA)

    May 2010 --- May 2012
    responsible for the dutch and German sites conducting studies with crofessionals

  • subcontractor

    September 2010 --- March 2012
    subcontractor for the German and benelux sites

  • Senior Clinical Research Associate

    March 2011 --- January 2012
    scra for the nice study

  • Senior Clinical Research Associate

    August 2011 --- October 2011

  • Senior Clinical Research Associate

    May 2011 --- August 2011

  • Senior Clinical Research Associate

    September 2010 --- April 2011
    Freelance CRA ii for the dutch sites replacing current CRA for 6 months

  • Clinical Research Associate (CRA)

    July 2010 --- September 2010
    co-monitoring for one project

  • Freelance Regional Clinical Research Associate

    April 2010 --- August 2010
    responsible for monitoring report reviewing at menb studies

  • Clinical Research Associate (CRA)

    January 2008 --- January 2010

  • Account Manager - Life Sciences

    January 2003 --- January 2008

  • Manager kliniek

    January 2002 --- January 2003

  • study coordinator

    January 1996 --- January 2002

Personality

Self Assessment :
DependabilityOrganizationProactivityProblem solvingReaction to stressSelf-disciplineSelf-confidenceSociabilityTrustOptimismInterest in knowledgeApproachabilityCharmCoordinationCritical thinkingCreative thinkingEfficiencyFlexibilityIndependenceWillingness to compromise

Knowledge

Self Assessment :
Diabetes Medical devices Phase I R&DA rising single dose tolerance study NegotiationAllergy and immunologyAnesthesiaCancerCardiologyCardiovascular diseasesClinical Data Management (CDM)Clinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial budgetingClinical trial managementClinical trialsColorectal surgeryContract negotiationData entryDrug InteractionDrug safety assessmentEDCEmergency medicineEnglishEthics submission and approval processGastroenterologyGCPGynecologic oncologyGynecologyHematologyICH GCP guidelinesInfectious diseasesInformed Consent ProcessInterventional RadiologyMicrosoft ExcelMicrosoft OfficeMonitoring Study ProgressNephrologyNeurological surgeryNeurosurgeryoncologyOperating RoomOrthopedic surgeryPatient Follow UpPediatricsPharmaceutical IndustryPhase I
LinkedIn Assessment :
Clinical trialsGCPClinical researchNeurologyoncologyClinical monitoringCardiologyDiabetesPharmaceuticalsClinical trial managementMedical DevicesRegulatory submissionsHematologyRegulatory affairsCancerICH-GCPEDCVaccinesGastroenterologyHypertensionExcelRheumatologyPhase IEnglishResearchElectrophysiologyQualification visitsRespiratoireLeukemiaCTMSCROClinical DevelopmentInfectious diseasesClinical Research AssociatesPharmaceutical IndustryClinical Data ManagementProtocolTherapeutic AreasMedical writingInterventional CardiologySite Management

Skills and Expertise

Self Assessment :
Interact with nurses Interact with physiciansAdverse event reportingAssist with proceduresAssist with routine testsAttend investigator meetingClinical data collectionCoach clinical staffCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorConduct post-marketing surveillance studyConfirm protocol complianceCoordinate with the ethics commiteeEthics committee submissionsGastrointestinal diseasesIdentify investigatorsIndentify sitesInitiation visitInformed consent processInteract with pharmacistsInteract with nursesInteract with physiciansLiaise with research teamMonitor a clinical studyMonitor dataMonitoring enrolmentMonitoring subject complianceNegotiate budget Pre-study procedures Prepare regulatory documentsRegulatory documentationRegulatory submissionsReport serious adverse events (SAE)Resolves queriesReview exclusion criteriaReview inclusion criteriaReview monitoring reportsSchedule sponsor monitoring visitsScheduling trial visitsSelect investigatorsSite managementSolve problemsTrain on site staffWork under specific instructions

Education

  • in Accountmanagement from Interselling in 2003
  • Bachelor in clinical research from hogeschool Rotterdam in 1999
  • in Middle Managemant Non Profit from Academy West Brabant in 1987
  • RN in IC/CC from Ignatius Hospital Breda in 1983

Training and Certification

  • Declaration of Helsinki in 2017 Training
  • Pharmaco vigilance in 2017 Certification
  • GCP in 2016 Certification

Languages

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

Work Preferences

  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    BrightOwl freelancer :    20-30 Hours per week
  • International:
    Yes

Area / Region

The Netherlands

Others

Driving License
  • Yes

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