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Summary

facilitate and coordinate all aspects of clinical audits and the site management process iaw international conference on harmonization Good Clinical Practice (ich-gcp) guidelines, Food and Drug Administration (FDA) regulations, european commission on Clinical trials directive, local and regional regulations and company standard operating procedures (sops). i conduct facility clinical audits to assess approved science)" >Protocol and Regulatory Compliance and manage required Documentation for all phases of Clinical trials. i develop collaborative relationships with clinical investigation sites to ensure data generated from their Clinical Trial database is eligible for successful local and international scientific Quality Assurance, and regulatory audits.

Experiences

Past Experience

  • CCRA

    January 2010 --- December 2015

  • Clinical Monitor

    January 2010 --- August 2011

  • CCRA

    January 2009 --- January 2010

  • Clinical Research Associate (CRA)

    January 2007 --- December 2008

  • Lead Research Assistant

    January 2007 --- January 2008

  • Clinical Research Coordinator (CRC)

    January 2005 --- December 2006

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailAuthenticityCollaborationAssertivenessCommunicativeCoordinationProactivitySelf-disciplineWillingness to compromise

Knowledge

LinkedIn Assessment :
Clinical trialsGCPClinical researchCTMSICH-GCPData CollectionClinical monitoringData ManagementResearchSPSSProtocolTherapeutic AreasQuestionnairesInfectious diseasesPublic HealthEpidemiologyLiterature ReviewsQuantitative ResearchSurvey ResearchClinical Data ManagementCROClinical DevelopmentSOPReport WritingClinical Research AssociatesData AnalysisTeam LeadershipBiotechnologyPharmaceutical IndustryOperations ResearchRegulatory affairsEDCIRBmanagementClinical trial managementPatient recruitmentElectronic Data ManagementFDA GMPGood Clinical Practice (GCP)Clinical Trial Management System (CTMS)Electronic Data Capture (EDC)

Skills and Expertise

Self Assessment :
Create SOPs Design case record forms Develop clinical trial protocols Monitor a clinical study Write papers Write protocolsAdministrative supportAdverse event reportingAdvise on strategyApprove monitoring reportsAssemble regulatory applicationsAssist with site trainingAttend investigator meetingCoach clinical staffCollaborate with project teamCollaborate with principal investigatorCommunicate with sponsorConduct close-out visitsConduct the trial

Education

  • MSc. in Clinical Research Adminstration. Hons from University of Liverpool in 2012
  • Bachelor’s Degree in BSc (Nursing), Registered Community Health Nursing (RCHN), Nursing Administration, Nursing Research from University of Eastern Africa Baraton in 0000

Training and Certification

  • Certified Clinical Research Associate, CCRA in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
SWAHILI
Professional Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Senior Clinical Research Associate (CRA)
  • Locations I am interested in:
    Kenya South Africa Tanzania Uganda
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    80% FTE
    BrightOwl employee :    80% FTE
  • International:
    Yes

Area / Region

Nairobi South, Nairobi, Nairobi County, Kenya

Others

Driving License
  • Yes

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