BrightOwl Loader Loading

Experiences

Current Experience

  • Clinical Research Associate (CRA) Wavre, Belgium
    Since March 2017

    Combination of in-house tasks and on-site visits in France

  • Doctoral Researcher Leuven, Belgium
    Since September 2012

    Doctorate “Gene repression in birds” bij Prof. Schuit, Labo Genexpressie groep, KU Leuven:

    RT Qpcr, PCR, cell culture, cDNA manufacturing, dissections, analyses of microarray data, statistical analyses

  • Member of Technical Board Mechelen, Belgium
    Since September 2008

    Responsible for the dance part of the club: lessons, teachers, technical advise, promotion
    Responsible for the gymflex kamp and promotion (link with commission promotion)
    Responsible for replacements when trainers cannot be in the class
    Responsible for overview diploma of a trainer

Past Experience

  • CRA Trainee Wavre, Belgium
    October 2016 --- February 2017

    Limited experience in performing own MVs

    • Issues and queries
    • Source documentation review and SDV
    • Meeting with SC and PI and other departments
    • Drug accountability
    • Pharmacy and investigator binders

    Following and helping during QV, SIV, MV and TV

    Experience in CMA/in-house tasks

    • Follow-up and resolve issues and queries
    • Contact with the sites by mail and phone
    • Prepare/complete the binders

    Experience in study start-up

    • Collecting documents from site (for SIV)
    • Plan SIVs
    • Binders’ preparation
    • Ask for access to EDC system

    Limited experience in ICF validation in Dutch and EC submission deadlines

Personality

Self Assessment :
Critical thinkingProblem solvingOrganizationIndependenceAnalytical thinkingAssertivenessAttention to detailCoordinationCuriosityFlexibilityInterest in knowledgeResponsibilityTrustCollaborationProactivityEfficiencyIndividualityResult OrientedWillingness to compromise

Knowledge

Self Assessment :
Animal models BiostatisticsAnalysisBioinformaticsBiomedical SciencesCancerClinical trialsData AnalysisDatabasesDNADNA extractionELISAEnglishExperimentationGeneticsGenomicsGraphPad PrismGynecologic oncologyLaboratoryLaboratory ResearchLaboratory TechniquesMicrosoft ExcelMicrosoft PowerpointMicrosoft WordOutlookPatient Follow UpPCRProblem SolvingqPCRResearchRNA isolationSamplingStatistical Data AnalysisTeachingCleanroomBiotechnologieICH guidelines21 CFR Part 11Adverse Events (AE)Analytical Method ValidationCancer ResearchClinical operationsClinical monitoringClinical researchClinical Study DesignClinical study reportsClinical Trial Management System (CTMS)Clinical trial managementCRFCROCTMSData entryData ManagementDrug AccountabilityeCRFEDCElectrocardiogram (ECG)Electronic Data Capture (EDC) Enzyme-linked immunosorbent assay (ELISA)Ethics submission and approval processGood Clinical Practice (GCP)Informed Consent ProcessInformed Consent DocumentsIVRSPhases of clinical development (phase I to IV)Phase IIPhase IVPhase IIIStandard Operating Procedure (SOP)Start-upsTeamworkTime Management

Skills and Expertise

Self Assessment :
Analyze data Control data Interpret dataAdjust methodsAnalyze data/information to determine potential relationships.Assist with experimentsAttend seminars, courses and meetings within and outside the companyCollect dataConduct animal studiesConduct limited data and/or statistical analysis.Conduct literature searches.Conduct university research Data validationDesign scientific experimentsDocument data collection systemEnsure data integrityInterpret dataInterpret analytical resultsInterpret scientific dataOral presentationpcrPerform routine testsPlan experimentsPrepare manuscriptPresent data at congressProcure and prepare samplesPromotional materialsRead medical literature to maintain current awareness and knowledgeResearch at universitiesSolve problemsTeachingUse laboratory techniquesValidate dataVerify data Monitor a clinical study Report dataAnswer, transfer and handle incoming calls as needed.Act as the main line of communication between the sponsor and the investigator Interact with nurses Interact with physiciansCollaborate with principal investigatorCollaborate with medical teamCollaborate with project teamCommunicate with investigatorConduct maintenance visitscontrol different protocol versions and other essential documentsData verificationEnsure consistency between the protocol and CRFFollow up projectsInteract with nursesInteract with physiciansInteract with pharmacistsInteract with pre-clinical scientistsInterpret research resultsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage subject consent formManage trial master file (TMF)Manage subject safetyMonitor dataPlan work to meet objectives and deadlinesResolves queriesReview dataReview exclusion criteriaReview data interpretationReview informed consent processReview inclusion criteriaSchedule trial visitsWrite final reports

Education

  • Master in Biomedical Sciences from KU Leuven in 2012

Training and Certification

  • ICH-GCP in 2017 Training
  • Course on Laboratory Animal Science II in 2015 Certification
  • English course B1 Treshold in 2015 Certification
  • French course A2 Waystage in 2015 Certification
  • Academic English writing course in 2012 Certification
  • Instrumental technical skills in 2012 Certification
  • Course on Laboratory Animal Science I in 2010 Certification
  • Animator in 2007 Certification
  • Competency of Teach& Type in 2003 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Administrative Assistant Associate Scientist associate Clinical Project Manager Bioinformatician Biomedical Scientist Clinical Research Consultant Clinical Research Coordinator Clinical Safety Associate Clinical Study Nurse (SN) Clinical Supply Manager Clinical Trial Assistant (CTA) Clinical Trial consultant Clinical Trial Coordinator (CTC) Clinical Trial Specialist (CTS) Clinical Trial Manager (CTM) CTA Manager Data Manager Field Clinical Research Specialist Junior Scientist Lab Scientist Preclinical Scientist Project Assistant QA Consultant R&D Scientist Research Assistant Research associate researcher Scientific consultant Scientific Researcher Scientist Team Assistant Assistant Professor Clinical Data Manager (DM) Clinical Research Associate (CRA)
  • Positions I am NOT interested in:
    Account Manager Chemical Analyst Chief Financial Officer (CFO) Engineer Equipment Engineer Field Clinical Engineer Field Service Engineer Industrial Design Engineer Industrial Pharmacist Master Thesis Master student Mechanical Technician Medical Writer Nurse Ph.D. Student PhD Candidate PhD researcher PhD student Physician Physical Therapist Physiotherapist President R&D engineer Regulatory Affairs Assistant Regulatory Affairs Associate Regulatory Affairs Consultant Regulatory and Start-Up Specialist Regulatory Affairs Manager Regulatory Project Manager Sales representative Sales Manager Scientific Writer
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    No

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes