PROFESSIONAL EXPERIENCE:
Research study:
• Research Protocol writing and implementation
• Writing of research papers and presentation at international conferences
Clinical Research Site selection and set up:
• Identification of Principal Investigators
• Site selections
• Site Assessment and/or Initiation visits
• Training of Clinic Trial sites (from Start up to study Close out)
• Research budget management
Clinical Research Associate:
• Assessment of research sites suitability to perform Clinical Trial (Studies)
• Initiation Visits to start the study
• Interim Monitoring visits with the purpose to evaluate and employ remedial actions
• Close out visits
• Writing of Reports (Assessment, Initiation, Monitoring and Audit)
Laboratory Auditor:
• Assessment of research laboratories suitability to perform Clinical Research Activities/Studies
Pharmacy And Regulatory Affairs:
• Assessment of research Pharmacy suitability to perform Clinical Research Activities/Studies.
• Oversight of Drugs accountabilities and Destructions
• Regulatory and Ethics Submissions and follow ups.
Good Clinical Practices:
• ICH-GCP training to research sites
• Training of research staffs on specifics of a research protocols such as Source Documentations and Regulatory Affairs
• Development of Quality Management Plan to support Research sites
Management:
• Member of interview panel for hiring new Clinical Operations staffs.
• Member of bid defence team for the selection of CROs/Vendors
• Planning of Monitoring Visits schedules
• Risk Identification/Escalation and Reports to Senior management
• Performance Review of site Monitors (CRAs)
• Oversight Quality Assessment Visit of contracted CROs/Vendors
• Facilitation and Coordination of the Study sites management
• Coordination/Supervision of site Monitors (CRAs)
• Supervision and training of Trainee CRAs
Others:
• Attended B.Tech in Pharmacy Course and Human Resources course at Twsane University in 2006 - 2007, Pretoria.
• Attended Epidemiology course in Infectious Diseases & Bioethics at WITS Medical School in Jan-March 2012.
• Attended Postgraduate Immunology Course (non-degree purpose) at University of Cape Town (UCT) Health Sciences, Immunology Department in Jan-July 2013.
EMPLOYMENT:
2000 - 2005: Tutoring students in French, Biology, Mathematics and Chemistry.
01 May 2004 – 20 Sep 2004: Lecturer at Dawnview High School in Primrose (South Africa).
24 Sep 2004 – 15 Jan 2006: Medical scientist at AMPATH laboratories - Microbiology Pomona branch (South Africa).
23 Jan 2006 – 30 Oct 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.
01 Nov 2006 – 28 Feb 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.
01 May 2007 - Mar 2010: 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. Research Pharmacy and Laboratory Audits. 75% of my job is traveling to research sites funded by NIH/DMID across the whole African continent.
Mar 2010 – 28 Feb 2011: 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). Research Pharmacy and Laboratory Audits. 75% of my job is traveling to research sites funded by NIH/DAIDS across the whole African continent.
01 Mar 2011 – 01 Aug 2012: 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. Research Pharmacy and Laboratory Audits. 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.
01 Aug 2012 – 15 Feb 2013: Oversee CRAs activities, in addition responsible for CROs oversights (Quality Assessment Visit) to ensure approved Quality Management Plans are followed. Review and approval of Site Monitoring reports and Quality Assessment Reports, 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.
18 Feb 2013 – 09 Aug 2013: Senior Clinical Research Associate at ClinTec International. Contracted to Novartis Vaccines and Diagnostics (NVD). 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. Research Pharmacy and Laboratory Audits. 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.
12 Aug 2013 – 15 Aug 2014: Senior Clinical Research Associate at Safrimed. Contracted to Sanofi-Aventis. 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. Research Pharmacy and Laboratory Audits. 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.
15 Aug 2014 – To date: Consultant Senior Clinical Research Associate and Project Manager. Conduct all CRAs activities such as Feasibility, Regulatory Submissions, Quality Assessment Visits, Initiation Visits, Interim Monitoring Visits, Close Out visits and Visit Reports, Laboratory and Pharmacy Audit Visits. Provide Project Management support as well as site Personnel Training. Ensure Quality Management Plans are followed. Provide Oversight activities when external CROs are used by Reviewing and Approving Site Monitoring Reports and to support Protocol Director/Director of Clinical Operations as applicable.
CLINICAL TRIAL EXPERIENCE
Genitourinary: A phase III, controlled, randomised, multi-center, two-arm study to evaluate the effectiveness of two Antiretroviral Therapies to prevent the sexual transmission of HIV-1 in serodiscordant couples.
Digestive System: An observational, non-randomised, single centre, study to evaluate differences and similarities of H. pylori genotype isolated from children and adults.
Cardiovascular: A phase III, double-blind, controlled, randomised, multi-center, parallel group study to evaluate the efficacy and safety of a Hypercholesterolemia therapy in High Cardiovascular Risk Patients Not adequately controlled with their Statin Therapy.
Cardiovascular/Metabolic diseases: A phase III, double-blind, randomized, placebo-controlled, parallel-group, multi-centre study to evaluate cardiovascular outcomes during treatment with type 2 diabetic patients (T2DM) after an Acute Coronary Syndrome event.
Infections/ Parasitic Diseases: A phase I, double-blind, controlled, randomised, single centre, dosage-escalation study to evaluate the safety, immunogenicity, reactogenicity of Malaria vaccine in semi-immune healthy adults.
Infections/Parasitic Diseases: Open-label, longitudinal, randomised, single centre, study to evaluate multi-drug efficacy among children who present with uncomplicated falciparum malaria.
Infections/ Parasitic Diseases: A phase II, double-blind, controlled, randomised, single centre, dose-range finding, study to evaluate the safety, immunogenicity, and efficacy of Malaria vaccine in children using rabies vaccine.
Infection/ Parasitic Diseases: A longitudinal and cross-sectional, observational study to evaluate malaria mortality and morbidity in children living in a malaria stable transmission area.
Infection/ Parasitic Diseases: A prospective observational cohort study to measure the incidence of malaria and antibody titers.
Infection/ Parasitic Diseases: An observational study to evaluate the development of humoral and cellular immune responses to malaria blood stage antigens following prenatal exposure to malaria as well as the risk factors and mechanisms associated with congenital malaria or exposure of the fetus to malaria blood stage antigens.
Infection/ Parasitic Diseases: A phase I, single-blind, non placebo-controlled, randomised, single centre, study to compare three different combination regimens for treatment of uncomplicated malaria.
Infection/ Parasitic Diseases: A phase II, open-label, non placebo-controlled, randomised, single centre, longitudinal study to compare two combination anti-malarial regimens of uncomplicated malaria.
Infections/Parasitic Diseases: A phase I, open-label, controlled, randomised, single centre, study to evaluate the effect of pre-clearance of latent MTB before BCG revaccination vs. BCG revaccination alone in tuberculin skin test (TST) positive adults.
Infections/Parasitic Diseases: A phase I, double-blind, placebo-controlled, randomised, single centre, leukapheresis study to evaluate cellular immune responses in unvaccinated BCG and HIV negative adults.
Infections/ Parasitic Diseases: A phase II, proof concept, placebo-double-blind, controlled, randomised, multi- centre study to evaluate the safety, immunogenicity and efficacy of Tuberculosis vaccine in HIV positive healthy adults.
Infections/ Parasitic Diseases: A phase II, open-label, controlled, randomized, multi-centre parallel study, to compare the responses of the initiation of NNRTI-based versus PI-based Antiretroviral Therapy in HIV-Infected infants who have and have not previously received single dose Nevirapine for prevention of Mother-to-Child HIV transmission.
Infections/Parasitic Diseases: A phase IV, open-label, active controlled, non-randomised, single centre, study to assess the agreement between the Tuberculin Skin Test (TST) and Interferon Gamma Release Assays (IGRAs) in children and evaluate the influence of Mycobacterium tuberculosis (M. tb) exposure, HIV status, cellular immunity, nutritional status, and age.
Infections/Parasitic Diseases: A phase I, double-blind, placebo-controlled, randomised, single centre, study to evaluate the safety and acceptability of a male microbicide applied to the penis each morning and after every sexual exposure.
Respiratory: A double-blind, placebo-controlled, randomised, single centre, study to evaluate the clinical course of the effect daily oral zinc supplementation plus standard antibiotics in children with acute Pneumonia.
Respiratory: A cross-sectional, single centre, observational study to determine the etiology of respiratory cryptosporidiosis in children with diarrhoea.
Respiratory: A phase 1/2A, double-blind, controlled, randomised, multi-centre, dose-range finding, study to evaluate the safety, tolerability and immunogenicity of attenuated intranasal vaccine against Respiratory Syncytial Virus (RSV) and Para-influenza virus in healthy children and infants.
Respiratory: A phase IV, open-label, controlled, randomised, multi-centre study to determine the optimal time to start antiretroviral therapy (ART) to maximize survival in HIV-infected and ART naïve persons with cryptococcal meningitis (CM).
Respiratory: A phase IV, observer blinded, controlled, randomised, multi-centre study to evaluate the immunogenicity, safety and tolerability of a Trivalent subunit Influenza vaccine in Healthy subjects aged 50 years and above.
Respiratory: A phase IIb, double-blind, randomised, placebo-controlled, multi center dose-ranging study to evaluate an anti-asthmatic drug in patients with moderate to severe, uncontrolled asthma.
Respiratory: A phase IIb/III, open-label, randomised, multi-center study to evaluate the long-term safety and tolerability of an anti-asthmatic drug in patients with moderate to severe, uncontrolled asthma.
PRESENTATIONS:
PRESENTATIONS:
Medical University of Southern Africa, Pretoria, South Africa, Department of Virology: Lecturer (2004-2006). Lecture topics: Prions diseases and Gastro-enteric viruses (Rotaviruses, Calici-viruses, Adenoviruses and Astroviruses).
Ehouman MA, Dewar J, and Steele AD (2002). Efficacy of various primer pairs in RT-PCR analysis to detect Caliciviruses in diarrhoeal stool. Poster presented at the MEDUNSA annual Academic day in Pretoria.
Ehouman MA, Dewar J, and Steele AD (2002). Efficacy of various primer pairs in RT-PCR analysis to detect Caliciviruses in diarrhoeal stool. Presented at the 3rd South African Virology conference in Mpumalanga.
Ehouman MA, Dewar J, Esona M, and Steele AD (2003). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002. Poster presented at the Medunsa annual Academic Day in Pretoria.
Ehouman MA, Dewar J, Esona M, and Steele AD (2004). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002. Presented at the Medunsa annual Academic Day in Pretoria.
Ehouman MA, Dewar J, Esona M, and Steele AD (2004). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002. Presented at the 26th African Health Sciences Congress in Kenya.
Ehouman MA, Dewar J, Esona M, and Steele AD (2005). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002. Presented at the 4th South African Virology conference in Cape Town.
Ehouman MA, Dewar J, Esona M, and Steele AD (2006). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002 – Vaccine implication. Presented at the 26th African Health Sciences Congress in Egypt.
Ehouman MA, Dewar J, Esona M, and Steele AD (2006). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002 – Vaccine implication. Poster presented at the 8th Commonwealth Congress on Diarrhoea and Malnutrition at Dhaka (Bangladesh).
Ehouman MA, Dewar J, Esona M, and Steele AD (2006). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002 – Vaccine implication. Presented at the 14th Biennial Congress of the South African Society for Microbiology in Pretoria.
Ehouman MA, Dewar J, Esona M, and Steele AD (2006). Sequence analysis of VP4 and VP7 genes of G1 rotavirus circulating in South Africa and Africa between 1995-2002 – Vaccine implication. Presented at the 1st International Congress of Central Asia Infectious Diseases in Bishkek (Kyrgyzstan).
EDUCATION:
Last School Attended : High School of ABOISSO (Côte d`Ivoire)
Highest Std. Passed : Senior Certificate in 1990
Subjects : Mathematics; Physical Science; Biology; Philosophy, English
French; History & Geography
ACHIEVEMENTS:
• Received an Honour Board in third year (1986), in fourth year (1987), and six year (1988) at high school because of a good average.
• Received an Honour Board in Mathematics and Statistics (achieved 100% in both subjects) at the Medical School of ABIDJAN (1990-1991).
• Graduate in 2002 with distinction in Molecular Biology for BSc (Hons.) Degree.
• Selected by the MEDUNSA research committee for exchange program in Germany in 2003.
• Won the 1st place Award at Medunsa academic day for the best postgraduate research paper, 2004.
• Won the 1st place Award at South African Society for Microbiology best oral research paper presentation, 2006.
• HIV/AIDS Care and Counseling Certificate obtained with distinction, 2005.
• Selected among the 7 African best Junior Scientists and awarded a Travel Bursary by UNCTAD`s Network of Centres of Scientific Excellence (UK) to present a paper at the “First African Conference on Structural Biology” in George and to attend the “3 Dimensional Electron Microscopy” workshop in Cape Town (24 Oct -1 Nov 2006).
• Awarded Aeras “Silver Cup” in September 2011 for Good Performance.
• Awarded “High Performance achievement and a once-off cheque” by Aeras management for Dedication, Commitment and Hard work in 2012.
• Project Management Certificate Obtained at UCT with Distinction in 2012.
TERTIARY EDUCATION:
PhD in Immunology (Part-time)
University of Cape Town (UCT), South Africa
Project Management Certificate, 2012
University of Cape Town (UCT), South Africa
HIV/AIDS Care and Counseling Certificate, 2005
University of South Africa, South Africa
MSc. (Masters) MED Virology, 2004
Medical University of the Southern Africa, South Africa
BSc. (Hons) (MED) Virology, 2002
Medical University of the Southern Africa, South Africa
BSc. Microbiology and Physiology, 2001
University of South Africa, South Africa
Information Technology Diploma, 1998
Gauteng Computer College
MBCHB Degree (stopped in 6th year), 1990 - 1996
Medical Faculty of Abidjan (Côte d`Ivoire).
CERTIFICATES / DIPLOMAS / DEGREES
CERTIFICATES
1982-1983 : C.E.P.E (Primary School Certificate)
1986-1987 : B.E.P.C (Equivalent to the “Ordinary level” School certificate
1989-1990 : Senior Certificate
2004-2005 : Certificate in HIV/AIDS care and Counseling
2012 : Certificate in Project Management
DEGREES
2000-2001 : BSc. In Microbiology and Physiology
2001-2002 : BSc. (Hons) in Medical Virology
2004-2005 : Master (MSc.) in Medical Virology
COMPUTER DIPLOMAS
1996-1997 : Microsoft Publisher, windows 3.1, Windows 95, 98, 2000 and XP; Lotus 1, 2, 3,
Bookkeeping, Excel, Access, Database V, WordPerfect 6.0
1997-1998 : Computer Technology (Repair, Upgrade, and Microsoft office package
Assemble a computer); Microsoft office package (Access, Excel, Windows 98,
PowerPoint, Word).
INTERNAL IT TRAINING
2007- 2013 : MS Presentation, Internet applications, Electronic Data Capture, Clinical Team
Management Service and Electronic Patient Diaries (PHT),
Electronic Data Capture (CASCADE, Timeaus, EMMES, LiveLink, INFORM V5.0, MySite, IMPACT Polaris and Clubnet), Rave modules and EDC (Medidata).
TRAINING:
1993 - 1996: Trained in Gastro-enterology, Paediatrics, Gynaecology and Obstetrics, Neuro – surgery, General Surgery, Pneumology, Ophthalmology, Haematololy and Genetics at the Medical University of Abidjan (Côte d`Ivoire).
2001 - 2004: Trained as a Medical Researcher (Virology) at the Medical Research Council of South Africa (MRC/Medunsa Diarrhoeal Pathogens Research Unit) (South Africa).
2002 - 2003: Exchange Research Program at University of Ulm (Germany).
2005 – Oct 2006: Trained as Lab Manager and Medical Researcher Assistant (Virology) at the Hepatitis and HIV/AIDS Research Unit (HHRU/Medunsa) (South Africa).
Nov 2006 - Feb 2007: Trained as Laboratory Auditor by Pharmaceutical Product Development (PPD)-SA.
23 Jul-02 Aug 2007: Trained as a Clinical Research Associate in Cambridge (United Kingdom)- Participated in an internal training programmme comprising 10 comprehensive modules focusing on theory, practice, techniques, system use and soft skills. The modules concentrate on the many tasks a Clinical Research Associate has to perform in the conduct of various phases of a clinical trial. The training programme comes to fruition when the trainee CRA attends and passes PPD`s Clinical Foundation Programme; a requirement for all CRAs who join PPD regardless of experience. On successful completion of the Clinical Foundation Programme, the individual attends a number of observational and co-monitoring visits to site to allow a better understanding of the role of the Clinical Research Associate.
Sep 2011 - Nov 2011: Refresher Training on Ethical and Regulatory Aspects of Clinical Research with the National Institute of Health US (NIH), Department of Bioethics.
24 - 26 Jan 2012: Refresher Training on Good Clinical Laboratory Practice (GCLP).
15 Jun 2012: Refresher Training on Good Clinical Practice (GCP).
REFERENCES:
1- Dr. Zinhle Makhatini
Medical Virology Department (Hepatitis and HIV/AIDS Research Unit - HHRU/Medunsa)
University of Limpopo (Medunsa Campus)
Tel: (012) 521 3037 Cell: ******** Fax: (012) 521 5794
E-mail: ********
2- Prof. John Dewar
University of South Africa
Tel: (011) 4713112 Cell: ********
E-mail: ********
3- Mr. Tiri Towindo
Principal Clinical Team Manager
Pharmaceutical Product Development (PPD-SA)
Tel: (011) 8829420 Cell: ********
E-mail: ********
4- Mrs Robin Clark-Jones (has left the company)
Global Clinical Trial Mananger at AERAS
Tel: (1) 301 547 2937
E-mail: ********
5- Prof Clive Gray
HOD, Department of Immunology
University of Cape Town (UCT)
Tel: (021) 650 6616
E-mail: ********
6- Gustav Schellack (has left the company)
Clinical Trial Manager at Norvatis
Tel: (27) 714621277
E-mail: ********
7- Nthabiseng Kobedi
Clinical Project Leader at Sanofi-Aventis
Tel: (27) 716001012 or (27) 792355613
E-mail: ********