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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 science)" rel="nofollow">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 science)" rel="nofollow">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 • 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 science)" rel="nofollow">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 science)" rel="nofollow">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 science)" rel="nofollow">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 science)" rel="nofollow">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 science)" rel="nofollow">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 science)" rel="nofollow">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 in 0000 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

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