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Summary

with 4 years of practice as a Clinical Research Associate in a Pharmaceutical company, i’m experienced in all aspects of monitoring (initiation visits, on-site monitoring visits, close-out visits and site support visits), site management and feasibility assessment processes within Phase II and iii Clinical trials.

i’ve performed study start-up activities including preparation and follow-up of submissions to the Ethics committee and maintain communication with the Ethics committees, both within belgium and the netherlands.

on a personal level i have excellent Planning and organizational skills and i’ve got an eye for detail. i have strong Communication Skills, and a motivated, enthusiastic and targeted personality.

due to my social skills and my ability to work independently, both working in a group as well as on my own, are no problem for me.

i strongly believe that both my experience and my personality will provide a perfect match with my upcoming projects as a Freelancer.

Experiences

Current Experience

  • Clinical Research Associate (CRA)


    Since September 2015

    paediatric pain study (belgium – netherlands – united kingdom)

    • assure Communication between the sponsor and the Investigator, and assure Communication with the CRO
    • prepare and conduct site support visits
    • generate necessary reports
    • provide support to the site on Patient Recruitment
    • perform in-house monitoring and adequate follow-up according to ich-gcp, local regulations and SOP's

    Paediatric Pain Study (Belgium – Netherlands – United Kingdom)

    • Assure communication between the Sponsor and the Investigator, and assure communication with the CRO
    • Prepare and conduct Site Support Visits
    • Generate necessary reports
    • Provide support to the site on patient recruitment
    • Perform in-house monitoring and adequate follow-up according to ICH-GCP, local regulations and SOP's

  • Clinical Research Associate (CRA)


    Since November 2013

    Phase III pain study (belgium)

    • assure Communication between sponsor and Investigator
    • assure collaboration with Hospital Pharmacy and Laboratory, experience with a central Laboratory
    • preparation and follow-up of submissions to Ethics committee, maintain Communication with Ethics committee
    • conduct gcp presentation and introduction to site staff 
    • prepare and conduct necessary site visits:
      • initiation visit
      • on-site monitoring visit (sdv, ae review, dcf resolution, drug accountability, data collection, detect and follow-up on science)" rel="nofollow">Protocol deviations and quality issues, motivation of site, assist site in trial-related tasks,…)
      • close-out visit
    • perform in-house monitoring
    • generate necessary reports
    • perform quality and safety controls
    • provide site support on Patient Recruitment (advertisement in newspapers, on Social Media, gp-letters, …)
    • coordinate, prepare and maintain Clinical Trial Documentation (tmf - isf) 
    • report and review issues with Project Manager
    • participate in Investigator meeting

    Phase III Pain Study (Belgium)

    • Assure communication between Sponsor and Investigator
    • Assure collaboration with Hospital Pharmacy and Laboratory, experience with a Central Laboratory
    • Preparation and Follow-up of submissions to Ethics Committee, maintain communication with Ethics Committee
    • Conduct GCP presentation and introduction to Site Staff 
    • Prepare and conduct necessary Site Visits:
      • Initiation Visit
      • On-site Monitoring Visit (SDV, AE review, DCF resolution, drug accountability, data collection, detect and follow-up on Protocol Deviations and quality issues, motivation of site, assist site in trial-related tasks,…)
      • Close-Out Visit
    • Perform in-house monitoring
    • Generate necessary reports
    • Perform quality and safety controls
    • Provide site support on Patient Recruitment (Advertisement in Newspapers, on Social Media, GP-letters, …)
    • Coordinate, prepare and maintain Clinical Trial Documentation (TMF - ISF) 
    • Report and review issues with Project Manager
    • Participate in Investigator Meeting

Past Experience

  • Clinical Research Associate (CRA)

    November 2013 --- September 2015

    Phase II pain study (the netherlands) 

    • assure Communication between sponsor and Investigator
    • assure collaboration with Hospital Pharmacy and Laboratory, experience with a central Laboratory
    • preparation and follow-up of submissions to Ethics committee, maintain Communication with Ethics committee
    • conduct gcp presentation and introduction to site staff 
    • prepare and conduct necessary site visits:
      • initiation visit
      • on-site monitoring visit (sdv, ae review, dcf resolution, drug accountability, data collection, detect and follow-up on science)" rel="nofollow">Protocol deviations and quality issues, motivation of site, assist site in trial-related tasks,…)
      • close-out visit
    • perform in-house monitoring
    • generate necessary reports
    • perform quality and safety controls
    • provide site support on Patient Recruitment (advertisement in newspapers, on Social Media, gp-letters, …)
    • coordinate, prepare and maintain Clinical Trial Documentation (tmf - isf) 
    • report and review issues with Project Manager
    • participate in Investigator meeting

  • Clinical Research Associate (CRA) - Clinical Trial Assistant

    February 2013 --- October 2013

    Phase II pain study (belgium) 

  • Clinical Research Associate (CRA) - Clinical Trial Assistant

    May 2012 --- October 2013

    Phase III pain study (belgium)

    • assure Communication between sponsor and Investigator
    • prepare and follow-up of submissions to Ethics committee, maintain Communication with Ethics committee
    • provide administrative and logistical support to the study team
    • coordinate, prepare and maintain Clinical Trial Documentation (tmf - isf) 
    • prepare and conduct necessary site visits:
      • initiation visit
      • on-site monitoring visit
    • perform quality and safety controls and tracking of safety reporting activities

Personality

Self Assessment :
Attention to detailCollaborationCommunicativeCreative thinkingFlexibilityIndependenceInterest in knowledgeOptimismOrganizationProactivityProblem solvingResult OrientedSelf-disciplineSociability

Knowledge

Self Assessment :
21 CFR Part 11AnesthesiaBiologyClinical monitoringClinical researchClinical study reportsClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCoachingCommunication SkillsComplianceElectrocardiogram (ECG)Electronic Data Capture (EDC) EnglishEthics submission and approval processGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)ICH guidelinesInformed Consent ProcessMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMultilingualOutlookPatient recruitmentPatient Screening and RecruitmentPediatricsPhase IIPhase IIIPresentation SkillsQuality Control (QC)Safety reportingSocial MediaSocial SkillsTeamworkTime ManagementTrainingTranslation

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Control data Interact with nurses Interact with physicians Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAssess site feasibilityAssist study siteAttend investigator meetingAttend seminars, courses and meetings within and outside the companyCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct maintenance visitsConduct site initiationConduct the trialcontrol different protocol versions and other essential documentsCreate clinical project documents according to the protocolDiscuss treatments with investigatorEnsure consistency between the protocol and CRFEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Ethics committee applicationFacilitate sponsor monitoring visitsHandle incidentsIdentify investigatorsInteract with CROsInteract with nursesInteract with pharmacistsInteract with physiciansMaintain strong relationshipsManage multiple projectsManage trial master file (TMF)Monitor dataMonitoring subject complianceSchedule trial visitsSite managementStudy-related documentsTeachingUnderstand protocolsVerify datawrite and maintain clinical evaluation reports

Education

  • Bachelor in Secundary Education - Biology/History from KHLeuven in 2010
  • Master in Kinesiology from KULeuven in 2007

Training and Certification

  • K.U.Leuven Faculty of Medicine - Additional Training ‘Clinical Research’ in 2013 Training
  • ICH - GCP in 2014 Certification
  • ICR - CRA certification in 2012 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    BrightOwl freelancer :    16 - 24 Hours per week
  • International:
    Yes

Area / Region

Roosdaal, Belgium

Others

Driving License
  • Yes

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