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Experiences

Current Experience

  • Project Coordinator

    Nairobi, Kenya
    Since September 2015

Past Experience

  • Clinical Research Associate (CRA) Nairobi, Kenya

    July 2012 --- September 2015

  • Clinical Research Associate Nairobi, Kenya

    December 2011 --- July 2012

  • Clinical Research Associate (CRA) (Trial Monitor) Kampala, Central Region, Uganda

    September 2008 --- November 2011

  • Quality Assurance Monitor Mombasa, Kenya

    February 2007 --- August 2008

  • Reaserch Nurse Manager Nairobi, Kenya

    July 2004 --- January 2007

Personality

Self Assessment :
Attention to detailAssertivenessCollaborationCoordinationCritical thinkingDiligenceEfficiencyOrganizationProactivityResult OrientedSelf-confidenceSociabilityStrategic thinkingProblem solvingResponsibilitySelf-disclosureFlexibilityApproachabilityAnalytical thinking

Knowledge

Self Assessment :
BiostatisticsAdverse Events (AE)Aseptic TechniquesAuditingBiological Drug DevelopmentBudget ManagementBudget NegotiationClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical SuppliesClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCommunication SkillsComplianceContract negotiationCRF designCROData cleaningDeveloping Clinical Trial ProtocolsDrug AccountabilityDrug DeliveryDrug development processeCRFEDCEfficacy trialsEnglishEthics submission and approval processGood Clinical Practice (GCP)Good Laboratory Practice (GLP)Healthcare ManagementInfectious diseasesInformation Management SystemsInformed Consent ProcessInternational Project ManagementLeadershipManaging Clinical Trial SuppliesMS ProjectNursingOutlookPatient Follow UpPatient recruitmentPatient Screening and Recruitmentpeople managementPhase IIPhase IIIPhase IVPowerPointProblem SolvingProject CoordinationProject ManagementProject PlanningQuality Assurance (QA)Quality Control (QC)Quality ManagementQuality Management System (QMS)Quality AuditingQuality SystemsRegulatory affairsRegulatory submissionsReport WritingResearchRisk AssessmentRisk ManagementSafety reportingSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Study protocolsSupervising CRAsSupply ManagementTeam LeadershipTeamworkTeam BuildingTeam ManagementTime ManagementTrainingVerificationWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Interact with nurses Interact with physicians Interpret data Search literature on clinical trials Write protocolsAct as the main line of communication between the sponsor and the investigatorAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdministrative supportAdverse event reportingAdvise on strategyAnalyze data/information to determine potential relationships. Monitor a clinical studyApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assess quality process issuesAssign activitiesAssist study siteAssist with site trainingAttend at steering committee meetingsAttend investigator meetingAttend seminarsApprove drug supply Attend seminars, courses and meetings within and outside the companyCalculate timelines for conducting and completing the trialCalculate trial timelinesCoach and provide guidance to clinical staff.Coach clinical staffcollaborate in research projects at universitiesCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationComplete case report form (CRF)Complete study proceduresConduct literature searchesConduct research at universitiesConduct site initiationConduct studiesConduct supply issue resolution activitiesConduct the trialConfirm protocol compliancecontrol different protocol versions and other essential documentsControl protocol versionsCoordinate logisticsCoordinate projectsCoordinate with the ethics commiteecoordinating research projectsCoordinationCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate standard operating procedure (SOP)Create study documentsData verificationDesign case record form (CRF)Design clinical presentationDesign study documentsDesign trial master file (TMF)Determine availability of facilities and equipment at the siteDetermine needsDetermine potential relationshipsDevelop ICH/GCP compliant processesDevelop strong internal relationships with stakeholdersDevelop study timelinesDevelop supply plansDevelop supply strategyDevelop training materialsDirect co-workersDirect co-workers to achieve resultDiscuss treatments with investigatorDistribute study documentsDistribute trial suppliesDocument employees training requirementsEnsure consistency between the protocol and CRFEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Establish professional relationships with partnersEthics committee submissionsExecute internal/external quality assurance assessmentsFacilitate sponsor monitoring visitsFollow up projectsFollow up training programsFollow-up of external auditsFollow-up of internal auditsGuide staffHandle callsIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialIdentify investigatorsIdentify risksIdentify sitesImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Indentify clinicians to conduct clinical trialsInformed consent processInitiate clinical trials Interact with computer specialistsImplement ProcessesInteract with CROsInteract with ethics committeeInteract with nursesInteract with KOLInteract with pharmacistsInteract with physiciansInteract with statisticiansInteract with regulatory stakeholdersInterpret dataInterpret research resultsInventory ManagementLabeling compliance with local regulationsLead teamsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record dataLogging enrolmentMaintain strong relationshipsManage clinical suppliesManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage complexityManage projects resourcesManage research projectsManage risksManage study supplyManage subject consent formManage trial master file (TMF)managing a small teamManuscript reviewMonitor dataMonitor Key Performance Indicators (KPI's)Monitoring enrolmentMonitoring subject complianceNegotiate budget Negotiate payment schedulesNegotiate protocol details NegotiationNetworkObserve trends in dataOperate research equipmentOral presentationOrganise meetingsPatient recruitmentPeople managementPlan work to meet objectives and deadlinesPlanning clinical studiesPre-study procedures Prepare external auditsPrepare internal auditsPrepare regulatory documentsPrepare responses to health authority queriesproject managementPromotional materialsProvide input to process improvement initiativesProvide study site fileProvide support for scientific and/or technical projectsProvide technical supportProvide trainingQuality control processR&DRead medical literature to maintain current awareness and knowledgeRegulatory submissionsRegulatory documentationReport Key Performance Indicators (KPI's)Report serious adverse events (SAE)Report study conclusionsReport technical problemsResolves queriesRespond to audit findingsRetrieve study documentsReview clinical study reportsReview dataReview data interpretationReview exclusion criteriaReview inclusion criteriaReview monitoring reportsReview protocolsReview quality control activitiesReview reportsReview study protocolsReview vendor metricsSchedule sponsor monitoring visitsSchedule trial visitsScheduling trial visitsScreen patientsSearch literature on clinical trialsSelect investigatorsSelect sitesSerious Adverse Event (SAE) ReconciliationSet up a clinical studySet up research projectsShipment of biological specimenSite managementSolve problemsStudy-related documentsSupervise clinical monitorsSupervise trial suppliesTeachingTrain off site staffTrain on site staffTrain StaffUnderstand protocolsTranslate strategy into operational plansUpdate Clinical Trials Management System (CTMS) Verify dataWork collaboratively with the other members of the clinical research team Work cross-functionallyWork under specific instructionsWork with coordination and data management teamsWrite documentsWrite final reportsWritten presentation

Education

  • Master of Science in Clinical Trials from London School of Hygiene and Tropical Medicine in 2016
  • Bachelor of Science in Healthcare Systems management from Kenya Methodist University in 2015
  • Diploma in Nursing from Kenya Medical Training College in 2004

Training and Certification

  • GCP in 2007 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Full Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM) Clinical Trial Manager (CTM) Clinical Research Associate (CRA) Senior Clinical Research Associate (CRA) Clinical Trial Coordinator (CTC)
  • Locations I am interested in:
    Nairobi, Kenya
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer :    40 Hours per week
  • International:
    No
  • Availability:
    Jul 2018 : 100%
    Aug 2018 : 100%
    Sep 2018 : 100%
    Oct 2018 : 100%
    Nov 2018 : 100%

Area / Region

Nairobi, Kenya

Others

Driving License
  • Yes

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