BrightOwl Loader Loading

Summary

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

Experiences

Past Experience

  • 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.

  • Project manager

    January 1995 --- January 1998
    monitoring a variable kind of studies, both intra- and extra-mural.

  • Teacher Anatomy

    September 1992 --- March 1993
    Teaching anatomy to students at the academy for physical therapy. replacing the current Teacher.

  • Physicaltherapist

    January 1979 --- January 1988
    physicaltherapist all over the Hospital (all kind of patients, ages and deseases) with specialisation in orthopaedics.

Personality

Self Assessment :
CollaborationOrganizationInnovative thinkingFlexibilityAnalytical thinkingAttention to detailSelf-disciplineAssertivenessCoordinationCreative thinkingCritical thinkingIndependenceInterest in knowledgeSociabilityProblem solvingProactivityTrust

Knowledge

Self Assessment :
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
LinkedIn Assessment :
Clinical trialsOrthopedicClinical researchMedical DevicesHospitalsClinical monitoringHealthcareCTMSBiomechanicsClinical DevelopmentGCPForeign LanguagesStatisticsCoachingTraumaOrthopedics

Skills and Expertise

Self Assessment :
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

Education

  • 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 in 0000 Certification

Languages

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

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Clinical Research Associate (CRA) Clinical Research Consultant Clinical Research Nurse Clinical Research Associate (CRA) Project Coordinator Clinical Research Coordinator Clinical Trial Manager
  • Locations I am interested in:
    Nederland
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    BrightOwl freelancer :    24-32 Hours per week
  • International:
    Yes

Publications

    Expert has 3 publications (Will be avalible with full profile)

Area / Region

Netherlands

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Netherlands

Other similar Candidates in this location (country / city)

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like