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Summary

i currently work for the kenya Medical Research institute collaboration with cdc in kisumu, kenya as a Quality Assurance manager/CRA. i have a bachelors degree in Nursing from la trobe University, melbourne australia (2011)i have 8 years Clinical research experience with 4 years working as a CRA for various clincial trials.i have also worked as a Clinical Monitor Consultant for 2 research organizations.

i am looking for a job as a CRA as i aim to become a senior CRA in any CRO

Experiences

Current Experience

  • Quality Assurance (QA) Manager

    Kisumu, Kenya
    Since February 2012

    Clinical monitoring for all Clinical research projects in the organization, from study initiation to close out

    preapare sites for Clinical monitoring/audits

    Training of ich gcp guidelines for research staff

    develop standard operating procedures/policies for the organization

    Clinical monitoring for all clinical research projects in the organization, from study initiation to close out

    Preapare sites for clinical monitoring/audits

    Training of ICH GCP Guidelines for research staff

    Develop standard operating procedures/policies for the organization

Personality

Self Assessment :
Attention to detailAssertivenessDependabilityEfficiencyInterest in knowledgeOrganizationFlexibility

Knowledge

Self Assessment :
Adverse Events (AE)CAPAClinical monitoringClinical researchClinical trialsCMC Regulatory AffairsCommunication SkillsCompliance with regulationsCRFDrug regulatory authoritiesDrug safety assessmenteCRFEthics submission and approval processGood Clinical Practice (GCP)

Skills and Expertise

Self Assessment :
Create SOPs Build and manage the Trial Master File (TMF) Monitor a clinical studyAct as the main line of communication between the sponsor and the investigatorAdverse event reportingArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess adverse reactionsAssess subject safetyAssess site feasibilityAssist study siteAssist with site trainingBuild trial master file (TMF)Capture data on source documentsClinical data collectionCommunicate with investigatorCommunicationComplete case report form (CRF)Conduct close-out visitsConduct site initiationConduct the trialConfirm protocol compliancecontrol different protocol versions and other essential documentsControl protocol versionsCreate SOPsCreate standard operating procedure (SOP)Ensure consistency between the protocol and CRFEnsure good clinical practice (GCP)Ensure data integrityEnsure data consistencyInformed consent processManage clinical trial files/documentsManage complexityMonitor dataMonitoring enrolmentReport serious adverse events (SAE)Respond to audit findingsResolves queriesSupervise clinical monitors

Education

  • Bachelor in nursing from La Trobe University Melbourne Australia in 2011

Training and Certification

  • ICH GCP GUIDELINES TOT TRAINING in 2012 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Senior Clinical Research Associate (CRA) CRM
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Kenya

Others

Driving License
  • Yes

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