i have 9 years of exeprience in Clinical trial management whose 6 years in Clinical monitoring activities (regulators affairs, site Qualification, siv, rmv, cov). my work experience allowed me to travel in many west africa and central africa countries. i have a strong knowledge of gcp/ich guideline and trial regulations in subsaharan africa. my experiences in Clinical monitoring are focused on Infectious diseases. i worked on many projects sponsored by Pharmaceutical and academic institutions. i can communicate both in English and French and have a good command of Electronic Data Capture system (edc rave) , electronic management of essential documents used for Clinical trials. my values are: integrity-discipline-no discrimination based on gender, race, and ethnicity-equity
Freelance Senior Clinical Research Associate (CRA)Mali, Burkina Faso
Since April 2017
a phase iiib comparative trial of seasonal vaccination with the malaria vaccine rts,s/as01, seasonal malaria chemoprevention and of the two interventions combined. sponsorized by london school of hygiene & tropical Medicine, sin : 207284 (malaria-099)
A phase IIIb comparative trial of seasonal vaccination with the Malaria vaccine RTS,S/AS01, seasonal malaria chemoprevention and of The two interventions combined. Sponsorized by London School of Hygiene & Tropical Medicine, SIN : 207284 (MALARIA-099)
Freelance Senior Unblinded Clinical Research Associate (CRA)BURKINA FASO, SENEGAL
Since October 2016
a Phase 2 randomized, multi-center double-blind, placebo-controlled study to evaluate the safety and immunogenicity of the v920 (rvsvΔg-zebov-gp) ebola Virus vaccine candidate in hiv-infected adults and adolescents. sponsored by dalhousie University, canada.
A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents. Sponsored by Dalhousie University, CANADA.
Freelance Senior Clinical Research Associate (CRA)Kambia, Northern Province, Sierra Leone
Since May 2016
A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola
Freelance Senior Clinical Research Associate (CRA)BURKINA FASO, COTE D'IVOIRE, NIGERIA
Since May 2016
A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines a Aï26.ZEBOV and/or MVA-BN-Filo
associate Clinical Project Manager Burkina Faso, GabonAugust 2010 --- April 2016
infectious disease ( malaria, pneumococcal diseases)
- 2010-2014 : home and community management of fever/malaria and pneumonia in children under – five: a cluster randomized controlled trial of an integrated approach in a rural district of burkina (sponsored by who/tdr)
- october 2013 to february 2014: impact of g6pd deficiency prevalence of malaria infection in sickle Cell patients under 15 year, living in burkina faso. (support fund for Health Research / ministry of Health, 2012 edition).
- april 2015: situational Analysis of Communication for seasonal malaria chemoprevention in burkina faso. malaria consortium
- 2011-2014: immunogenicity, safety and reactogenicity of gsk biologicals’ 10-valent pneumococcal conjugate vaccine when administered to children with sickle Cell disease between 8 weeks and 2 years of age”. it s a Phase III Clinical Trial. (trial registration: nct01175083, funded by gsk Biological)
epidemiological studies in non communicable disease ( asthma, sickle Cell disease)
- november 2014 to june 2015: prevalence and environmental risk factors of asthma in children under 15 years in urban and rural areas in burkina faso: a comparative cross-sectional study (support fund for Health Research / ministry of Health, burkina faso, edition 2013)
- 2013 – 2014: sickle Cell disease in children 0-23 months in burkina faso: prevalence and place of the ief and HPLC in the diagnosis of the disease.
since july 2015 : a randomized, controlled, double blind, single-center phase 1 Clinical Trial to evaluate safety, tolerability, immunogenicity and efficacy of caf01 and aluminum hydroxide as adjuvants for the malaria vaccine candidate gmz2 in healthy adult african.( sponsor : centre de recherche medical de lambarene (cermel) www.cermel.org , gabon)
2013 - 2015 : feasibility, acceptability and costs of a community – based Diagnostic and Treatment package for malaria for varying degrees of severity in sub-saharan africa (study id : funded by who/tdr).
- 2011 – 2012: assessment of zinc absorption from a phytic acid rich complementary Food, consumed by young children immediately after the addition of the Enzyme phytase. a randomized single blind study (promoteur : irsat/dta/eth – zurich /fp7).
AdaptabilityApproachabilityAttention to detailCommunicativeCreative thinkingEfficiencyOrganizationProactivityResponsibilitySelf-disciplineResult OrientedInterest in knowledge
R&D Scientific writing21 CFR Part 11Allergy and immunologyBudget ProcessClinical monitoringClinical Data ManagementClinical Study DesignClinical study reportsClinical SuppliesClinical researchClinical trial designClinical trial managementCRF designCROData AnalysisDeveloping Clinical Trial ProtocolsElectronic Data Capture (EDC) EpidemiologyGood Clinical Practice (GCP)Grant PreparationICH guidelinesPhases of clinical development (phase I to IV)Public HealthQuality Control (QC)RecruitingReport WritingResearchTeam ManagementTeamworkVaccinesClinical Trial Management System (CTMS)
Skills and Expertise
Create SOPs Design case record forms Monitor a clinical study Search literature on clinical trialsApprove monitoring reportsApprove consent documentsAssess site feasibilityAssist study siteCapture data on source documentsCollaborate with principal investigatorDesign case record form (CRF)Design clinical trialDesign exclusion criteriaDesign trial master file (TMF)Ethics committee applicationManage clinical trial files/documentsManage trial master file (TMF)R&DSchedule trial visitsScheduling trial visitstranslation english to frenchTranslation French to English
Master in Epidemiology and Clinical Research from School of Public Health of University OUAGA I Joseph Ky Zerbo in 2017
Post Graduate in Medicine from University of Ouagdougou in 2010
Training and Certification
INC RESEARCH TRAININGS FOR CRA in 2017 Training
11th Annual African Vaccinology Course in 2015 Training
Data survival analysis with STATA in 2014 Training
PAREXEL LEARNING MANAGEMENT SYSTEM in 2016 Certification
11th Annual African Vaccinology Course in 2015 Certification
Clinical trial design in 2015 Certification
good clinical practice in 2015 Certification
Monitoring in 2015 Certification
good clinical practice in 2013 Certification
health research in 2013 Certification
health research in 2011 Certification
good clinical practice in 2010 Certification
Expert has 3 publications (Will be avalible with full profile)