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Summary

i am currently a senior Clinical Research Associate 2 (sr CRA 2) at quintiles, where i have worked since january 2011 to date. i have an MSc in international Health from heidelberg University, germany, and a bsc in Nursing from the University of nairobi, and various other short courses.

cumulatively, i have over 10 years’ experience in research, spanning all aspects of Clinical trials lifecycle. starting out as an internal monitor in a who-run hiv Clinical Trial in 2004, i have had stints as a Data Manager, monitoring and evaluation officer for hiv programmes at a Teaching Hospital and back as a CRA at family Health international (fhi).

i have handled all the roles of a monitor as stipulated in the ich/gcp guidelines as well as the employers’ and sponsors’ requirements, including site identification, initiation, monitoring and close out. i have also been involved in site development for research-naïve sites, which has included intensive Training and mentoring.

 

being French-speaking, i have monitored francophone west africa, in east africa, central and southern africa.


i have worked in several Therapeutic Areas, for many sponsors, and in diverse site set-ups, adhering to various sops and other standards. i have worked on both vaccine and Treatment trials, and in Therapeutic Areas ranging from malaria, hiv, tb and some start-up work in non-communicable diseases.

 

i have also mentored many new cras and supported them to during the on-boarding process into core clinical research.

Experiences

Current Experience

  • Senior Clinical Research Associate II (Sr CRA 2)

    Nairobi, Kenya
    Since October 2012
    • perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and Good Clinical Practice.

    • mentoring new cras during on-boarding to support them to learn quintiles processes and systems.
    • 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 enrolment, 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.

    • in my work experience in this position, i have worked in francophone, anglophone and portuguese countries. 

    • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and Good Clinical Practice.

    • Mentoring new CRAs during on-boarding to support them to learn Quintiles processes and systems.
    • 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 enrolment, 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.

    • In my work experience in this position, I have worked in Francophone, Anglophone and Portuguese countries. 

  • Clinical Research Associate II (CRA 2)

    Nairobi, Kenya
    Since January 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 enrolment, 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.

    • in my work experience in this position, i have worked in francophone, anglophone and portuguese countries. 

    • 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 enrolment, 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.

    • In my work experience in this position, I have worked in Francophone, Anglophone and Portuguese countries. 

Past Experience

  • Senior Clinical Research Associate I (Sr CRA 1) Nairobi, Kenya

    October 2011 --- September 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 enrolment, case report form (crf) completion and submission, and data query generation and resolution.

    • in my work experience in this position, i have worked in francophone and anglophone countries. 

  • Clinical Research Associate (CRA) Nairobi, Kenya

    September 2006 --- July 2009

    • monitoring of Clinical trials to ensure Compliance with gcp, ICH guidelines, the science)" rel="nofollow">Protocol, FDA, fhi policies and sops, applicable local requirements and other standards as appropriate.
    • link between the site and the sponsor.
    • train site staff on specific science)" rel="nofollow">Protocol requirements and other applicable requirements.
    • retrieving of monitored crfs for onward transmission to Data Management.
    • reporting of and follow up of saes, pregnancies to final resolution.
    • query resolution and follow up any missing data.
    • manage the completeness of the regulatory binder at site and the central one.
    • supervise and provide technical assistance to other Clinical Research Associates (cras).
    • preparation of data monitoring plans, monitoring reports, final reports and/or Publications.
    • identify new sites and conduct assessment of sites for suitability for fhi studies, and participate in all stages of studies from site development, initiation, Interim and close-out monitoring stages of the trial(s).
    Training site staff and mentoring them in ich-gcp Compliance.
    • coordinating the shipment of study supplies, drugs, Laboratory equipment and reagents to all the 7 sites in africa.
    • preparation of study administration and Analysis tools, sops and manuals.

     • in my work experience in this position, i have worked in francophone, anglophone and portuguese countries. 

  • Monitoring and Evaluation Officer, HIV Projects Kenyatta Hospital, Nairobi, Kenya

    September 2005 --- September 2006

    • development of sops for these centres as part of the Hospital’s effort to acquire ISO 9001 certification, and ensuring they are adhered to.
    • preparation of quarterly reports for the Hospital and the funding agencies.
    • development of data collection tools for use at these centres.
    • analyzing data generated by the centres by exit interviews and other data collection systems.
    Teaching in Training programmes offered by vct centre (vct, dtc, couple vct, adherence counselling etc)
    • participation in the national quality assessment & assurance in vct (nqat), run by nascop.
    • development of Databases for entry of data generated from these areas.
    • assisting in monitoring of provision of quality services within the centres and in mentored sites within nairobi.

  • Clinical Research Associate/Quality Assurance Monitor Mombasa, Kenya

    April 2004 --- August 2005

    • maintaining internal Quality Control in a who-run multinational, multicentre Clinical Trial on impact of haart on mtct, pregnancy and breastfeeding in mombasa, kenya.
    • study clinic procedures: monitoring that they are done according to gcp, study science)" rel="nofollow">Protocol and sops.
    • case report forms/ Data Management: monitoring that all these are done according to ich/gcp guidelines.
    Laboratory: ensuring sops are adhered to and gcp reporting systems are followed.
    Procurement of who-prequalified arvs.
    • maintenance of essential documents files and other study documents.
    • liaison with external study monitor in site monitoring visits.
    • conducting site monitoring checks of study Laboratory and study clinic for Compliance with gcp.
    • assisting the principal Investigator (pi) in liaisons with the irb, dsmb and other partners.

Personality

Self Assessment :
Attention to detailApproachabilityAuthenticityDependabilityEfficiencyOptimismPerspectiveSelf-confidenceResult OrientedService orientedTrustWillingness to compromiseResiliencyIndividualityCommunicativeCritical thinking

Knowledge

Self Assessment :
Clinical monitoringICH-GCPEDCCTMSRegulatory SubmissionPatient recruitmentDrug AccountabilitySite MonitoringClinical operationsClinical trial managementClinical Site DevelopmentTraining and Mentoring Clinical Trial Management System
LinkedIn Assessment :
Clinical monitoringICH-GCPEDCGCPCTMSCROClinical trialsTherapeutic AreasClinical Data ManagementCRF designMedidataRegulatory submissionsPatient recruitmentDrug AccountabilitySite InitiationTrial ManagementClinical operationsInfectious diseasesSOPClinical researcheCRFInformVaccinesGCPsICFClinical Site ManagementClinical Site MonitoringCCRACRFClinical DevelopmentPharmacovigilance

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Create SOPs Design case record forms Guide students Interact with nurses Monitor a clinical study Write papersConduct close-out visitsConduct maintenance visitsConduct studiesConduct site initiationCreate SOPsCreate standard operating procedure (SOP)Creates a collaborative team environmentDesign case record form (CRF)Design clinical presentationDevelop clinical strategyDevelop supply plansDevelop study timelinesDevelop study metricsWrite papersWork under specific instructionsWork with coordination and data management teamsVerify dataUpdate Clinical Trials Management System (CTMS) Understand protocolsTrain on site staffTrain off site staffTeachingSite managementSelect investigatorsSelect sitesSerious Adverse Event (SAE) ReconciliationSearch literature on clinical trialsSet up a clinical studySchedule trial visitsSchedule sponsor monitoring visitsReview vendor reportsReview quality control activitiesReview protocolsResolves queriesReport Key Performance Indicators (KPI's)Quality control processMonitoring enrolmentMonitor dataManage trial master file (TMF)Manage Clinical Trial Management System (CTMS) Liaise with research teamEnsure data consistencyDocument data collection systemDocument adverse events

Education

  • Master of Science in International Health from Heidelberg University, Germany (Ruprecht-Karls-Universität Heidelberg) in 2010
  • Certificate in German Language from Goethe Institut, Mannheim-Heidelberg, Germany in 2009
  • Bachelor of Science in Nursing from University of Nairobi in 2001
  • Certificate in French Language from Alliance Française, Nairobi, Kenya in 2001

Training and Certification

  • ACRP in 2009 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Professional Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    7 weeks
  • Locations I am interested in:
    Côte d'Ivoire Kenya Tanzania Uganda
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Kenya

Others

Driving License
  • Yes

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