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Exemple d'expériences d'Ehouman,
freelance DETERMINE habitant l'Ain (01)

• Oversee CRAs activities,

  Jan 2012 - Jan 2013

  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.

• Lead Senior Clinical Research Associate

  Jan 2011 - Jan 2012

  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.

• 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.
  Jan 2010 - Jan 2011

  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.

• 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.
  Jan 2007 - Jan 2010

  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.

• 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.
  Jan 2006 - Jan 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.
  Jan 2006 - Jan 2006

• 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.
  2006 - 2007

• Lecturer

  at Dawnview High School in Primrose (South Africa).
  Jan 2004 - Jan 2004

• Medical scientist

  at AMPATH laboratories - Microbiology Pomona branch (South Africa).
  2004 - 2006

• Tutoring students in French, Biology, Mathematics and Chemistry.

  2000 - 2005