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I am very dedicated, hardworking and focused employee. I have a wealth of experience in all 4 phases of clinical trial back with my medical backgrounds. I have worked for Institutions, Government agencies, Sponsors and CROs. I have managed and trained as well study Staff. I am prepared to bring my expertise if an opportunity is given.

Lastly I am keen to relocate and work anywhere.

Experiences

Current Experience

  • Snr CRA

    South Africa
    Since March 2015
    Quality Management

    Provide internal Monitoring support as well as Feasibility, Regulatory Submissions, Quality Assessment, Laboratory & Pharmacy assessment support to the Clinic. Provide site Personnel Training. Provide ICH-GCP training to site staff. Ensure site Quality Management Plans are followed. Identification of potential site issues and development of Corrective Action/ Preventive Action (CAPAs) to assist clinical staff and ensure a timely resolution of those issues. Pro-actively prepare the Clinic for Audits and Regulatory inspections. Provide Oversight activities and assistance to the Principal Investigator (PI) and the Clinical Operation Team.

  • Snr CRA/Project Manager

    Pretoria, Gauteng, South Africa
    Since March 2015
    Project Management

    Provide internal Monitoring support as well as Feasibility, Regulatory Submissions, Quality Assessment, Laboratory & Pharmacy assessment support to the Clinic. Provide Project Management assistance to Principal Investigator (PI) and site Personnel Training. Provide ICH-GCP training to site staff. Ensure site Quality Management Plans are followed. Identification of potential site issues and development of Corrective Action/ Preventive Action (CAPAs) to assist clinical staff and ensure a timely resolution of those issues. Pro-actively prepare the Clinic for Audits and Regulatory inspections. Provide Oversight activities and assistance to the Principal Investigator (PI) and the Clinical Operation Team.

Past Experience

  • Director Sierra Leone; Liberia

    August 2014 --- February 2015
    Clinical Research Associates

  • Lead Senior Clinical Research Associate Johannesburg, Gauteng, South Africa

    August 2013 --- August 2014
    Clinical monitoring

  • Senior Clinical Research Associate (CRA) Cape Town, Western Cape, South Africa

    February 2013 --- August 2013
    Clinical monitoring

  • Lead Senior Clinical Research Associate/Acting Clinical Trial Manager Cape Town, Western Cape, South Africa

    March 2011 --- February 2013
    Clinical Research Associate

  • Senior Clinical Research Associate (CRA) Johannesburg, Gauteng, South Africa

    May 2007 --- February 2011
    Clinical Research Associate

  • Laboratory Auditor Johannesburg, Gauteng, South Africa

    November 2006 --- February 2007
    Clinical trials

  • Research Assistant /Lecturer Pretoria, Gauteng, South Africa

    January 2006 --- October 2006
    Research Assistant

  • Medical scientist Johannesburg, Gauteng, South Africa

    September 2004 --- January 2006
    Microbiology

  • Tutor Pretoria, Gauteng, South Africa

    January 2000 --- December 2005
    Biology

  • Lecturer Johannesburg, Gauteng, South Africa

    May 2004 --- September 2004
    Lecturer

Personality

Self Assessment :
Strategic thinkingWillingness to compromiseProactivityFlexibilityAnalytical thinkingEfficiencyInnovative thinkingOptimismProblem solving

Knowledge

Self Assessment :
Biochemistry Cell biology Diabetes Labtechnician Negotiation Phase I R&D21 CFR Part 11 Scientific writingActions and modes of action of drugs in the human speciesAdverse Events (AE)Allergy and immunologyActions and modes of action of human physiologyAuditingBiologyBiopharmaceuticalsBudget NegotiationBudget ProcessBudget ManagementCardiovascular diseasesClinical monitoringClinical researchClinical operationsClinical trial audits and inspectionsClinical study reportsClinical Trial SuppliesClinical Trial Management System (CTMS)Clinical trials

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Analytical skills Interact with physicians Interact with nursesAssess product quality issuesAssign activitiesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist study siteAssist with site trainingAttend at steering committee meetingsAttend investigator meetingAttend seminars, courses and meetings within and outside the companyBuild trial master file (TMF)Calculate timelines for conducting and completing the trialCoach staffcollaborate in research projects at universitiesCommunicate with investigatorCommunicate with sponsorComplete study proceduresConduct close-out visitsConduct literature searches.Conduct research at universitiesConduct site initiationConduct supply issue resolution activitiesContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.coordinating research projectsCreate clinical project documents according to the protocolCreate study documentsCreates a collaborative team environmentData verificationDesign case record form (CRF)

Education

  • Certificate in Monitoring, Evaluation and Surveillance from WITS University, School of Public Health in 2015
  • Certificate in Project Management from University of Cape Town (UCT), in 2012
  • Certificate in HIV/AIDS Care and Counseling from University of South Africa (UNISA) in 2005
  • Master (MSc.) in Medical Virology in Medical Virolody from Medical University of Southern Africa (MEDUNSA) in 2004
  • BSc. (Hons) in Medical Virology in Medical Virology from Medical University of the Southern Africa in 2002
  • BSc. In Microbiology and Physiology in Microbiology and Physiology from University of the South Africa (UNISA) in 2001
  • Diploma in Information Technology from Gauteng Computer College in 1998

Training and Certification

  • Human Subject Protection Training (OHRP) in 2016 Training
  • Clinical Trial mangement System in 2016 Certification
  • Refresher Training on Good Clinical Practice (GCP). in 2016 Certification
  • United Nations Department of Safety and Security - Basic Security in Field II in 2015 Certification
  • US Agency for International Development (USAID) Training on Monitoring & Evaluation (M&E) and Data Demand and Use Training. in 2015 Certification
  • Refresher Training on Ethical and Regulatory Aspects of Clinical Research with the National Institute of Health US (NIH), Department of Bioethics. in 2011 Certification

Languages

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

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Clinical Research Associate (CRA) Project Manager Clinical Operations Manager
  • Positions I am NOT interested in:
    not related to my expertise
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    any FTE% FTE
  • International:
    Yes

Area / Region

Abidjan, Lagunes, Côte d'Ivoire

Others

Driving License
  • No

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