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Experiences

Current Experience

  • Clinical Research Coordinator Phase 1 clinical trials
    Since October 2015
    healthy volunteers medical oncology

Past Experience

  • Advisor pediatric clinical trials
    October 2014 --- October 2015
    national coordinator BSPHO trials member of the SAFEPEDRUG consortium (http://safepedrug.eu)

  • Clinical Research Coordinator Roeselare, Belgium
    September 2010 --- October 2014

  • Teacher
    January 2010 --- June 2010

Personality

Self Assessment :
ApproachabilityAuthenticityCollaborationCommunicativeCoordinationCreative thinkingDiligenceEfficiencyFlexibilityIndependenceInnovative thinkingInterest in knowledgeKindnessOptimismOrganizationProblem solvingResponsibilitySociability

Knowledge

BrightOwl Assessment :
Clinical researchClinical trialsGood Clinical Practice (GCP)Phases of clinical development (phase I to IV)Informed Consent ProcessInformed Consent DocumentsStandard Operating Procedure (SOP)Principles and ethics of clinical researchEthics submission and approval processTeaching
Self Assessment :
Diabetes Phase I21 CFR Part 11Adverse Events (AE)AutoCADBiomedical SciencesBudget ManagementCancerCancer ResearchClinical Data ManagementCommunication SkillsClinical Data Management (CDM)Clinical DevelopmentClinical monitoringClinical researchClinical Study DesignClinical trial budgetingClinical trial designClinical trialsCoachingComplianceContract negotiationCRFCROData entryData ManagementDrug development processEarly development stageeCRFEDCElectronic Data Capture (EDC) Electrocardiogram (ECG)EndocrinologyEnglishEthics submission and approval processEvent ManagementGastroenterologyGood Clinical Practice (GCP)HospitalsHuman AnatomyICH guidelinesIMPDInformed Consent DocumentsInformed Consent ProcessInternal medicineISO 9001IVRSKnowledge of the drug development processLife SciencesMedical oncology Microsoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordoncooncologyOncology Clinical ResearchOutlookPatient Follow UpPatient recruitmentPatient Reported Outcome Measures (PROMs)Patient Screening and RecruitmentPediatricsPharmacodynamicsPharmacogenomics (study of genetic variation)PharmacokineticsPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PowerPointPrinciples and ethics of clinical researchProtocolQA complianceQuality of Life (QoL) outcomesRandomization and blindingRecruitingSafety reportingSerious Adverse Event (SAE)Social SkillsStandard Operating Procedure (SOP)Study protocolsTeachingTeamworkTeam BuildingTechnical SupportTime ManagementTrainingWriting Study Procedures and SOPs

Skills and Expertise

BrightOwl Assessment :
Work collaboratively with the other members of the clinical research team Interact with nurses Interact with physicians
Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Interact with nurses Interact with physicians Interpret data Report data Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdverse event reportingApprove consent documentsArchive study documentsArchive trial documentation and correspondence.Attend investigator meetingAttend seminarsBuild trial master file (TMF)Capture data on source documentsClinical data collectionCoachCoach and provide guidance to clinical staff.Coach clinical staffCoach staffcollaborate in research projects at universitiesCollaborate with medical teamCollaborate with principal investigatorCollect dataCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorCommunicationComplete case report form (CRF)Complete study proceduresConduct research at universitiesConduct studiesConduct the trialContact potential subjectsContract approvalcontrol different protocol versions and other essential documentsControl studiesControl protocol versionsCoordinate projectsCoordinationCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate standard operating procedure (SOP)Create study documentsCreates a collaborative team environmentcoordinating research projectsData entryDesign subject consent formDesign trial master file (TMF)Determine availability of facilities and equipment at the siteDevelop study budgetDevelop study metricsDirect co-workersDiscuss treatments with investigatorDistribute study documentsEnsure consistency between the protocol and CRFEnsure good clinical practice (GCP)Establish contractsEstimate subject complianceEthics committee applicationEthics committee submissionsEvaluate protocolsFacilitate sponsor monitoring visitsFeasibility analysis of proposed trial designFollow-up of external auditsFollow up training programsGastrointestinal diseasesGenerate regulatory submissions Identify and provide training to trial team and associated staffInformed consent processInteract with CROsInteract with computer specialistsInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansInterpret analytical resultsInterpret dataInteract with statisticiansInterpret electrical schematicsLabeling compliance with local regulationsLiaise with doctors and other professionals throughout the studyLiaise with doctorsLiaise with research teamlifescienceLogging enrolmentManage budgetsManage clinical suppliesManage clinical trial files/documentsManage subject consent formManage trial master file (TMF)Manage subject safetymanaging a small teamNegotiate budget NetworkOrganise meetingsPatient recruitmentPlan work to meet objectives and deadlinesPlanning clinical studiesPre-study procedures Prepare external auditsPrepare internal auditsPrepare regulatory documentsProvide trainingRead medical literatureReferral lettersRegulatory documentationRegulatory submissionsReport serious adverse events (SAE)Research at universitiesResolves queriesRespond to audit findingsRetrieve study documentsReview informed consent processReview protocolsSchedule trial visitsScheduling trial visitsScreen patientsShipment of biological specimenSolve problemsStudy-related documentsTrain on site staffTrain StaffUnderstand protocolsWork collaboratively with the other members of the clinical research team Work with coordination and data management teamsWork cross-functionally

Education

  • in Specific Teacher Training Programme in Health Science from Universiteit Gent in 2010
  • Master of Science (MSc) in Biomedische wetenschappen / Biomedical sciences from Universiteit Gent in 2009
  • in from Sint – Hendriks - & Zusters Maricoleninstituut Deinze in 2004

Area / Region

Hooglede, Belgium

Others

Driving License
  • No