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Summary

Clinical Research Specialist since 01 Aug 2012. Started as Clinical Research Associate per 01 Sep 2008. Experience in the following fields: - Cardiology (ACS) - Infectious diseases (fungal) - Gastro-intestinal (GERD in pediatric subjects) - Vaccination (CAP) - Oncology (NSCLC/MCL) - Vaccines (HPV) - Internal Medicine (MG) Project Management, BID defences, Kick Off meeting, Site Selection, Study Start Up, Site Initiation Visits, Site Monitoring Visits, Site Close-Out Visits, Provide Project Training to different parties.

Experiences

Current Experience

  • Clinical Research Specialist
    Since August 2014
    • Oversee the work of assigned CRAs, providing advice and guidance to help achieve quality deliverables on site. • Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per Contract. • May conduct site monitoring visits for a variety of protocols, sites and therapeutic areas. • Provide input, updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables. • Act as subject matter expert for operational conduct of the assigned protocol(s) at site • Ensure that new project CRAs are brought on board and receive relevant study information. • Provide input to line managers on their project team members’ performance relative to study tasks. • Conduct co-monitoring visits to manage data backlog, site compliance and quality issues, may be beyond home geography. • Act as site visit report reviewer. • May take on special project assignments related to function/corporate initiatives. • Act as Project Manager for studies (HPV and Zoster vaccine studies) in Portugal and the Netherlands. • Review and creation of Clinical Operation Plans • Attending BIDs after received proposal. • Act as CPM in absence of the regional CPM for international studies

Past Experience

  • associate Clinical Research Specialist
    August 2012 --- August 2014
    • Oversee the work of assigned CRAs, providing advice and guidance to help achieve quality deliverables on site. • Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per Contract. • May conduct site monitoring visits for a variety of protocols, sites and therapeutic areas. • Provide input, updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables. • Act as subject matter expert for operational conduct of the assigned protocol(s) at site • Ensure that new project CRAs are brought on board and receive relevant study information. • Provide input to line managers on their project team members’ performance relative to study tasks. • Conduct co-monitoring visits to manage data backlog, site compliance and quality issues, may be beyond home geography. • Act as site visit report reviewer. • May take on special project assignments related to function/corporate initiatives. • Act as Project Manager for studies (HPV and Zoster vaccine studies) in Portugal and the Netherlands. • Review and creation of Clinical Operation Plans • Attending BIDs after received proposal. • Act as CPM in absence of the regional CPM for international studies

  • senior Clinical Research Associate
    September 2011 --- August 2012
    • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. • Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. • Act as a mentor for clinical staff including conducting co-monitoring and training visits. • May provide assistance to the CTL with design of study tools, documents and processes.

  • Clinical Research Associate (CRA)
    September 2008 --- August 2011
    • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. • Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. • Act as a mentor for clinical staff including conducting co-monitoring and training visits. • May provide assistance to the CTL with design of study tools, documents and processes.

  • Employee
    January 2008 --- January 2008

  • Supervisor
    January 2006 --- January 2008
    Management of employees and being the first responsible for all activities in managing a restaurant.

  • Student
    January 2006 --- January 2007

  • Student
    January 2005 --- January 2006
    Study Biomedical Sciences

Personality

Self Assessment :
ApproachabilityIndependenceOptimismOrganizationKindnessInterest in knowledgeCompetitivenessCoordinationCollaborationCharm

Knowledge

LinkedIn Assessment :
Clinical trial managementClinical researchCROICH-GCPoncologyLife SciencesVaccinesCTMSPatient recruitmentEnglishGCPEDCClinical trialsTherapeutic AreasClinical DevelopmentClinical operationsRegulatory submissionsSOPProtocolPharmaceutical IndustryClinical monitoringInfectious diseasesCardiology

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAlzheimerApprove monitoring reportsArchive study documentsAssess site feasibilityAttend investigator meetingCoach clinical staffCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct monitor visitsConduct site initiationConduct the trialConfirm protocol compliancecoordinating research projectsDirect co-workersEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of Quality Management System (QMS) processesGastrointestinal diseasesManage Clinical Trial Management System (CTMS) Manage clinical trial files/documentsmanaging a small teamMonitor a clinical studyMonitor clinical trials Monitoring enrolmentProtocol managementProvide trainingProvide study site fileReport non-compliance incidentsRespond to audit findingsSelect investigatorsSite managementSolve problemsSupervise clinical monitorsTrain off site staffTrain on site staffVerify data

Education

  • MSc in Medical Biology from University of Amsterdam in 2007
  • in from Erasmus college Zoetermeer in 1998

Training and Certification

  • Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites, on 06 May 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    5 weeks
  • Work From Home:
    Yes, 2 to 5 days per week
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    Yes

Area / Region

Netherlands

Others

Driving License
  • Yes