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Summary

°Responsible for providing CRA support on the designated international clinical projects °Act as the main communication line between the pharmaceutical company and the investigative site during the conduction of the trial °Assuring the data quality of designated clinical projects °Working according to the highest standard of quality defined by SOPs and by Good Clinical Practice. °Supervising the progress of the designated projects within the responsible territory and provide regular updates to management °Supporting administrative aspects of clinical projects

Experiences

Current Experience

  • Sr. CRA on international Urology and Ophtalmology studies, pharmacology & medical devices, phase 1, 2, 3 Home Based, company based in Marlow, UK
    Since June 2013

    Review and collection of essential study documents following site initiation package approval ensuring input into the Monitoring plan by the relevant functional lines. conducts Investigator/site qualification visits, clinical site Initiation visits, clinical site monitoring visits and clinical site close-out visits Accountable for managing site performance (compliance with the respective protocol, applicable ICH/GCP guidelines, laws and regulations, and Sponsors procedures.and productivity) identify site issues and initiates corrective actions responsible for the management of site level tracking and reporting of adverse events (AEs and SAEs) and significant GCP non-compliance, source data verification of case reports and the facilitation of the resolution of clinical queries ensures the management of adequate site study supplies, requests replenishment from designated personnel, and performs investigational product accountability and reconciliation Develop site enrollment plans and contingencies, perform motivational meetings with the sites. Therapeutic Area/Lab Experience - Ophthalmology study with medical device – Phase I – Belgium - Ophthalmology study with intra ocular injection - Phase III – Belgium, Netherlands - Urology Neurogenic detrusor overactivity (NDO) paediatric study – Phase III - Belgium - Urology Overactive Bladder (OAB) paediatric study – Phase III – Belgium, Netherlands - Urology OAB study – Phase III - Belgium Key areas of Responsibility: • Monitoring Activities - Site Qualification, Site initiation, routine monitoring and close out visits - Assist the study coordinators and investigators with site issues - Review monitoring frequency vs. Monitoring plan. - Use of electronic CRFs - Source data verification - Query handling - SAE reporting and Follow Up - Accountability of clinical trial supplies - Maintenance of study files on site • Communication - Participate in TC/Meetings with Sponsor - Provide study specific training to study site personnel and create open communication - Attend investigator meetings and team meetings. - Contact EDS team to discuss bugs and difficulties in the CRF, query management and Source data verification - EC communication • Training - Attend trainings on monitoring plan, CRF completion, monitoring tools, study specific report requirements, Safety requirements, SAE reporting - Attend international team meetings: CRA meeting, Investigator meeting. - Therapeutic Area training Ophtalmology - Therapeutic Area training Urology - Lead CRA training - eLearning: SOPs, work instructions, TA, techniques, GCP, ICH, ISO 14155 - Training Dangerous Goods 1Apr14 • Administrative Tasks - Collect essential documents for TMF, Maintain Investigator site file - Create visit reports from site qualification till close out - Update Drug accountability system - Create study trackers - Create annual progress reports

Past Experience

  • Sr. Clinical Research Associate
    February 2012 --- April 2013
    Clinical Research Associate on international medical device studies for peripheral and coronary diseases.

  • Sr.Clinical Research Associate (CRA)
    September 2011 --- November 2011
    Creating SOPs, Forms and Monitoring Manual

  • Clinical Research Associate (CRA)
    November 2010 --- September 2011
    Site Manager (CRA) on phase1 studies in Belgium, UK, Berlin

  • Clinical Research Nurse
    January 2010 --- January 2011
    Coordination of Clinical trials (phase Ib -IV) both academic as industry sponsored. Main tasks : start up of new trials, budget calculation and negotiations, submission to ethics committee, recruitment coordination, patient contact, data entry into various eCRFs

  • Clinical Research Coordinator
    August 2009 --- November 2009
    ….

  • Nurse, Ergonomics, Industrial Hygiene
    June 1990 --- July 2009

  • Clinical Research Nurse
    May 2003 --- April 2006

Personality

Self Assessment :
Self-confidenceResiliencyAnger commandPerspectiveCuriosityAdaptabilityTrustProactivityFlexibilityCollaborationProblem solvingApproachabilityReaction to stressSelf-disclosureIndependenceAssertivenessOptimismSociabilityInterest in knowledgeIndividualityOrganizationEfficiencySelf-disciplineAttention to detailInnovative thinking

Knowledge

Self Assessment :
GastroenterologyEmergency medicineCardiovascular diseasesWriting Study Procedures and SOPsSearch literature on clinical trialsICH GCP guidelinesPhase IIMultiple dose tolerance studyMedical DevicesPhase IPreventative medicineEfficacy trialsSafety trialsMonitoring Study ProgressPatient Follow UpPatient Screening and RecruitmentInformed Consent ProcessEthics submission and approval processAllergy and immunologyClinical operationsClinical trial managementRespiratoryUrologyProtocolCTMSHealthcareClinical researchUrologyGood Clinical Practice (GCP)Family practiceCROPhase IIIData entryRandomization and blindingPhases of clinical development (phase I to IV)Vascular surgeryPulmonary diseasesPediatricsOrthopedic surgeryOphthalmologyInfectious diseases
LinkedIn Assessment :
Clinical trialsClinical researchICH-GCPClinical monitoringCTMSCROGCPElectronic Data Capture (EDC) LifesciencesMedical DevicesoncologyPharmaceutical IndustryClinical DevelopmentBiotechnologyClinical Data Management (CDM)HealthcareSOPRegulatory affairsCardiologyRegulatory submissions

Skills and Expertise

Self Assessment :
Conduct site initiation Interact with nursesCoach staffAdverse event reportingAttend investigator meeting Search literature on clinical trialsIdentify sitesData verificationPrepare regulatory documentsApprove patient information Interact with physiciansSchedule trial visitsSite managementInteract with ethics committeeCollaborate with project teamSchedule sponsor monitoring visitsInitiation visitFacilitate sponsor monitoring visitsConduct monitor visitsConduct close-out visitsIndentify sitesAssist study siteInformed consent processMonitor clinical trials Serious Adverse Event (SAE) ReconciliationReport serious adverse events (SAE)

Education

  • Post Graduate in Ergonomics and industrial hygiene from Universiteit Antwerpen in 1994
  • Bachelor's degree - RN in Nursing from St. Vincentius in 1981

Training and Certification

  • Continuous eLearning in 2014 Training
  • ICH-GCP in 2014 Training
  • Training Guidelines on Transportation of dangerous goods in 2014 Training
  • An introduction to the conduct and monitoring of clinical trials in accordance with ICH-GCP guidelines and other applicable legislation – CRA Workshop in 2010 Training
  • Be prepared for inspection/audit in 2010 Training
  • Motivation technics in 1997 Training
  • Back school instructor in 1996 Training
  • Lead CRA in 2014 Certification

Languages

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

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Senior Clinical Research Associate (CRA) Project Coordinator
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    Permanent placement% FTE
  • International:
    Yes

Area / Region

Boom

Others

Driving License
  • Yes