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Summary

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

    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

    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

    Overseeing Consulting works in the following activities-

    ICH-GCP Training to site Personnel; Monitoring Activities to sites conducting Clinical Trials (Initiation visit - Interim visit - Combo visit & Close Out visit); Feasibility studies/Site Qualification Visit, Laboratory & Pharmacy Assessment Visits to ensure the site capability to conduct a Clinic Trial; Monitors or Clinical Research Associates (CRAs) Training; Quality Assessment Visits.

    Project Management Assistance to Principal Investigator (PI); Ensure site Quality Management Plans are followed; Internal support to Clinical Sites for Regulatory Submissions; Development of Corrective Action/ Preventive Action (CAPAs) to assist clinical sites to ensure a timely resolution of sites issues; Preparation of the Clinic sites for Audits and Regulatory inspections.

  • Lead Senior Clinical Research Associate Johannesburg, Gauteng, South Africa
    August 2013 --- August 2014

    Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentations. Oversee sites payment based on completed monitored visits. Manage the day-to-day site requirements and trainings in line with approved Protocol procedures. Develops collaborative relationships with investigative sites and client company personnel.

  • Senior Clinical Research Associate (CRA) Cape Town, Western Cape, South Africa
    February 2013 --- August 2013

    Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentations. Oversee sites payment based on completed monitored visits. Manage the day-to day- site requirements and trainings in line with approved Protocol procedures. Develops collaborative relationships with investigative sites and client company personnel.

  • Lead Senior Clinical Research Associate/Acting Clinical Trial Manager Cape Town, Western Cape, South Africa
    March 2011 --- February 2013

    •  Lead Senior Clinical Research Associate at AERAS Global TB Vaccine Foundation. Performs and coordinates assigned aspects of the clinical monitoring processes in accordance with ICH-GCPs/Regulatory authority and IRBs/IECs rules and SOPs to assess the safety and efficacy of AERAS TB vaccines candidates currently under clinical trials globally. Provide training supports i.e. Protocols, ICF, Quality Management Plan, Source documentations, Site Trainings, etc. to selected sites. Furthermore, in countries where the monitoring activities are performed by a client company (Clinical Research Organization), supervise and coordinate the client company Clinical Research Associate activities with regards to the trial requirements.
    • Acting Clinical Trial Manager at AERAS Global TB Vaccine Foundation, oversee activities of CRAs from CROs (external CRAs), conduct sponsor Quality Assessment Visits to ensure approved Quality Management Plans are followed. Review and approve Site Monitoring reports and Assessment reports from external CRAs. Site Budget negotiation and Support to Protocol Director/Director of Clinical Operations. Lead CRA for co-sponsored TB vaccine study (Aeras and GSK) and performed pre-site assessment visits, site selections and sites budget negotiation. Member of the Aeras team to select for the winning Bidding CROs for Lab activities and Protocol monitoring contracts.

  • Senior Clinical Research Associate (CRA) Johannesburg, Gauteng, South Africa
    May 2007 --- February 2011

    • Clinical Research Associate at Pharmaceutical Product Development (PPD-SA) contracted to the National Institutes of Health - Division of Microbiology and Infectious Diseases (NIH/DMID) for the US government.

    Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentation. Develops collaborative relationships with investigative sites and client company personnel. 75% of my job is traveling to research sites funded by NIH/DMID across the whole African continent.

     

    •  Senior Clinical Research Associate at Pharmaceutical Product Development (PPD-SA) contracted to the National Institutes of Health- Division of Acquired Immunodeficiency Syndrome (NIH/DAIDS) for the US government.

    Performs and coordinates assigned aspects of the clinical monitoring process in the Therapeutics Research Program (TRP) reported under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and the Adult AIDS Clinical Trials Group (AACTG) networks, the Prevention Sciences Program (PSP) reported under the Microbicide Trials Network (MTN), the Vaccine Research Program (VRP) reported under the HIV Prevention Trials Network (HVTN) and HIV Vaccine Trials Network (HPTN) and the Basic Sciences Program (BSP) network for the Division of AIDS (DAIDS). 75% of my job is traveling to research sites funded by NIH/DAIDS across the whole African continent.

  • Laboratory Auditor Johannesburg, Gauteng, South Africa
    November 2006 --- February 2007

    Contractual Laboratory Auditor. Conducted audits for PPD on a contractual basis for a laboratory participating in the HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), the Adult Aids Clinical Trials Group (AACTG), for the National Institute of Allergy and Infectious Diseases (NIAID) for the US government.

  • Research Assistant /Lecturer Pretoria, Gauteng, South Africa
    January 2006 --- October 2006

     Research Assistant at the Hepatitis and HIV Research Laboratory and Part-time Lecturer at the University of Limpopo (Medunsa Campus) Lecturing Postgraduate students in Microbiology and Advanced Microbiology.

  • Medical scientist Johannesburg, Gauteng, South Africa
    September 2004 --- January 2006

    Medical scientist at AMPATH laboratories - Microbiology Pomona branch (South Africa).

  • Tutor Pretoria, Gauteng, South Africa
    January 2000 --- December 2005

    Tutoring students in French, Biology, Mathematics and Chemistry

  • Lecturer Johannesburg, Gauteng, South Africa
    May 2004 --- September 2004

    Lecturer at Dawnview High School in Primrose (South Africa).

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