if assignment of 80%, combination with trainig activities in 2ndary occuption would be possible:
independent status which enables to take individual asssignments as Trainer. long experience as Clinical Research Associate. this together with my licence, aggregation higher secondary Education and a recently obtained certification of Coach gives me the opportunity to offer Training in clinical research : in 1st instancy i will be offering monitoring Training for cras and ich-gcp-course. other services like mentoring are part of the offered package. for other trainings : please contact me to discuss feasibility. from 1990 CRA and sr-CRA in several companies and in a variety of indications. i worked in Phase I-ii-iii and iv. summer 2012 i obtained accreditation of certified Coach (open Coaching - annick noyens). summer 2011 followed course 'speakingnow' by a noyens.
Trainer Clinical Research RoosdaalApril 2014 --- October 2014
i provide course in Clinical research : 'ich-gcp' and 'conduct and monitoring of Clinical trials in accordance with ich-gcp and other applicable legislation'. actually preparing 'GMP', any topic in Clinical research can be discussed with client an evaluated upon feasibility.
Associate Clinical Project ManagerJanuary 2012 --- June 2012
coordinating aspects of Clinical research
Clinical Research Associate (CRA)November 2006 --- January 2010
Investigator screening, study preparation & start-up, routine monitoring, db cleaning, close-outs of studies, monitored by others.
Clinical Research Associate (CRA)January 1998 --- November 2000
monitoring viagra-trial (pre-launch-depression), cv-trial
Clinical Research Associate (CRA)January 1995 --- January 1996
Self-confidenceOrganizationIndividualityIndependenceCuriosityCollaborationService orientedAnger commandPerspectiveKindnessDependability
AdaptabilityService orientedSociabilityStrivingTrustWillingness to compromiseSelf-confidenceResiliencyProblem solvingApproachabilityAssertivenessAttention to detailCollaborationCoordinationCritical thinkingDiligenceFlexibilityIndependenceIndividualityInterest in knowledgeKindnessOptimismOrganizationProactivity
Phases of clinical development (phase I to IV)Clinical monitoringClinical trialsGood Clinical Practice (GCP)oncologyPatient Screening and RecruitmentScientific methodologyScreen patientsStandard Operating Procedure (SOP)GastroenterologyEthics submission and approval process
Safety trialsScreen patientsSerious Adverse Event (SAE)SOPToxicologyUrologyVaccinesInformed Consent Documents Diabetes Phase I R&DAnesthesiaCancerCardiologyClinical Data Management (CDM)Clinical monitoringClinical researchClinical Study DesignClinical trial budgetingContract negotiationCTMSData cleaningDrug InteractionDrug Safety and PharmacovigilanceDrug safety assessmentDrug Supply Management activitiesEfficacy trialsElectronic Data Capture (EDC) EndocrinologyEthics submission and approval processGastroenterologyGCPGood Clinical Practice (GCP)GynecologyICH GCP guidelinesInformed Consent ProcessManaging Clinical Trial SuppliesoncologyPatient Screening and RecruitmentPediatricsPharmaceutical IndustryPharmacodynamicsPharmacovigilancePhase IPhase IIPhase IIIPhase IVQuality Assurance (QA)Rheumatology
Skills and Expertise
Coordinate with the ethics commiteeCreates a collaborative team environmentDirect co-workersEthics committee submissionsExecute scientific projectsGuide staffConduct site initiationInteract with CROsInteract with ethics committeeLiaise with research teamlifescience Monitor a clinical studyProvide trainingSchedule trial visitsScreen patientsTrain on site staff Guide students Monitor a clinical studyCoach staffCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct site initiationConduct the trial
Assure medical quality Build and manage the Trial Master File (TMF) Control data Design case record forms Interact with nurses Interact with physicians Report dataAdverse event reportingApprove queriesArchive study documentsAssess adverse reactionsAssess site feasibilityAssist study siteAttend investigator meetingCapture data on source documentsCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresConduct close-out visitsConduct monitor visitsConduct site initiationConduct the trialConfirm protocol complianceCoordinate with the ethics commiteeCreate study documentsData verificationDesign case record form (CRF)Design clinical presentationDesign study documentsDesign subject consent formDesign trial master file (TMF)Develop ICH/GCP compliant processesDiscuss treatments with investigatorDistribute study documentsDistribute trial suppliesDocument adverse eventsDocument employees training requirementsEnsure data integrityEnsure good clinical practice (GCP)Estimate subject complianceEthics committee submissionsFacilitate sponsor monitoring visitsFinancial administrationFollow-up of internal auditsFollow-up of quality assurance activitiesGastrointestinal diseasesGuide staffIndentify clinicians to conduct clinical trialsIdentify investigatorsIndentify sitesInformed consent processInitiation visitInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansLabeling compliance with local regulationsLiaise with research teamManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage Quality Management System (QMS) documentationManage subject safetyManage subject consent formManage trial master file (TMF)Monitor a clinical studyMonitor clinical trials Monitor dataMonitoring enrolmentMonitoring subject complianceNegotiate budget Negotiate payment schedulesNegotiationOrganise meetingsPersuade clinicians to conduct clinical trialsPre-study procedures Prepare CMC source documents Provide study site fileProvide trainingQuality control processReferral lettersReport non-compliance incidentsResolves queriesRespond to audit findingsRetrieve study documentsReview exclusion criteriaReview inclusion criteriaReview queriesSchedule sponsor monitoring visitsSchedule trial visitsSelect investigatorsSerious Adverse Event (SAE) ReconciliationSite managementSolve problemsStudy-related documentsTrain on site staffTrain off site staffValidate dataVerify dataWrite papers
aggregation Higher Secondary Education in Teaching from Authorities in 1984
Licence in Physical Education from KU Leuven in 1983
Training and Certification
Course SpeakingNow in 2011 Training
Certified Coach in 2012 Certification
ACRP : Certified CRA-exam of the Association of Clinical Research Professionals, 2000 in 2000 Certification