I am a senior CRA with > 15 years experience in Medical Device Research. Experienced in orthopedics, trauma and sports. Besides conducting the clinical trials, I have als experience in gait analysis, basic statistics, organisation of investigator meetings. Support investigators with EC submission, developing study protocols. Mobile phone: +31 653573119
Clinical Research Associate (CRA) Europe
March 1998 --- May 2015
Starting as a CRA, my last function was Study Manager.
The working area was orhtopaedics and traumatology clinical research.
Clinical Research Associate (CRA)
March 1998 --- May 2015
Set up clinical trials; monitoring the sites; organise investigators meetings; data collection and verification; statistical analysis; Assisting in writing articles and poster-lay-out. Performing gait analysis measurements (EMG and Gonio inclusive). Keep participants motivated. Coordinate the trial: EC approval, Contracts with hospitals and 3rd parties.
January 1995 --- January 1998
Monitoring a variable kind of studies, both intra- and extra-mural.
September 1992 --- March 1993
Teaching Anatomy to students at the academy for Physical Therapy. Replacing the current teacher.
January 1979 --- January 1988
Physicaltherapist all over the hospital (all kind of patients, ages and deseases) with specialisation in orthopaedics.
CollaborationOrganizationInnovative thinkingFlexibilityAnalytical thinkingAttention to detailSelf-disciplineAssertivenessCoordinationCreative thinkingCritical thinkingIndependenceInterest in knowledgeSociabilityProblem solvingProactivityTrust
Serious Adverse Event (SAE)Clinical operationsCAPAGood Clinical Practice (GCP) R&D Medical devicesRegulatory submissionsUnderstanding of regulatory guidelinesInformed Consent DocumentsSports medicineClinical trial managementSurgical InstrumentsClinical researchPrinciples and ethics of clinical researchPhysical medicine and rehabilitationPatient Follow UpPatient Screening and RecruitmentICH-GCPGCPEnglishEfficacy trialsCTMSRegulatory RequirementsPatient Reported Outcome Measures (PROMs)Orthopedic surgeryOrthopedicMonitoring Study ProgressInformed Consent ProcessClinical study reportsClinical monitoringICH GCP guidelinesSOP
Skills and Expertise
Build and manage the Trial Master File (TMF)Complete case report form (CRF)Collaborate with project teamConduct post-marketing surveillance studyConduct site initiationConduct the trial Guide studentsConduct monitor visitsCoordinate with the ethics commiteeData verificationDesign clinical trialDesign post-marketing surveillance studyEnsure good clinical practice (GCP)Ethics committee submissionsEvaluate post-marketing surveillance studyManage Clinical Trial Management System (CTMS) Organise meetingsPresent data at congressCommunicate with sponsorConduct close-out visits Develop clinical trial protocols Interact with nurses Interact with physicians Interpret data Report data Analyze dataAdverse event reportingApprove monitoring reportsWrite protocolsAssist with experimentsAttend investigator meetingAttend seminarsCalculate trial timelinesCapture data on source documentsCollaborate with medical teamCollaborate with principal investigatorCommunicate with investigatorTrain on site staff Control data Monitor a clinical study Design case record forms Develop protocolsBuild trial master file (TMF)Assist study siteCoach clinical staffIdentify investigatorsIndentify sitesVerify dataSite managementMonitor clinical trials Patient recruitmentQuality control process
Associate’s Degree in CMDA Clinical Medical Device Associate from WMDO World Medical Device Organisation in 2013
in Epidemiology and public health from Erasmus Universiteit Rotterdam in 2009
Master in Health Science/ Human Movement Science from University of Maastricht in 1992
Master of Science in Human Movement Science from University of Maastricht in 1992
certificate in COPD; Neuroscience; from Foundation for Science and Education in 1988
Bachelor in Physical therapy from Academy for Physical Therapy in 1978
HBS-B in Highschool from Emmauscollege in 1973
Training and Certification
Introduction in clinical research; principes of epidemiologic data analysis; survival analysis for clinicians; biostatistics for clinicians in 2015 Training
Introduction in Health Services research; Principles of research in medicin and epidemiology; methode of public health research; epidemiology and health policy. in 1999 Training
project management in 1998 Training
CMDA in 2013 Certification
RSA course in 2011 Certification
Good Monitoring Practice in 2005 Certification
Certificaten Medical Device Associate Certification
Expert has 3 publications (Will be avalible with full profile)