FRANCIS OTIENO GUMBA

Positive, organized, and detail-focused professional with solid foundation in clinical research protocols and regulatory compliance. Possesses strong skills in data management and patient interaction, ensuring accurate and ethical conduct of trials. Committed to leveraging skills to support groundbreaking research and contribute to advancements in healthcare field.

Succesfully monitored,Protocol: An evaluation of the cluster-randomized pilot implementation of the RTS, S/AS01 malaria vaccine through routine health system in Western Kenya (MVIPE) -the protocol was WHO sponsored and was being implemented in 8 Counties (Migori, Homabay, Kisumu, Siaya, Vihiga, Kakamega, Bungoma &Busia)

Successfully coordinated Protocol: Strengthening the evidence on the RTS, S/AS01 malaria vaccine,assessment of safety and effectiveness using case-control studies in Western Kenya. (MVIP-CC Study) an EDCTP sponsored study

• Center for Innovative Drug Development and Therapeutic Trials for Africa-CDTAfrica, 11/01/23, Advanced Certificate in Clinical Trials Operations
• Good Clinical Laboratory Practice
• Good Clinical Practice Inspection /Audits
• Clinical Trials Inspection Course-World Health Organization
• Data Protection & Privacy Rights
• Introduction to Monitoring UKCRC Registered Clinical Trial Unit
• VIARES Clinical Research Talent Programme, 04/01/20 - 07/31/20

• Therapeutic /Surveillance Malaria, Sickle Cell, TB, HIV/AIDS
• A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.'s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9- 11 Months of Age-sponsored by Shanghai
• Strengthening the evidence on the RTS, S/AS01 malaria vaccine: assessment of safety and effectiveness using case-control studies. (MVIP-CC Study)
• An evaluation of the cluster-randomized pilot implementation of the RTS, S/AS01 malaria vaccine through routine health system in Western Kenya (MVIPE) -WHO sponsored study
• Phase IIb randomized, open-label, controlled, multi-center study of the efficacy, safety and immunogenicity of GSK Biologicals' candidate malaria vaccine RTS, S/AS01E evaluating schedules with or without fractional doses, early Dose 4 and yearly doses, in children 5-17 months of age living in sub-Saharan Africa (Mal 094)-GSK sponsored study
• Safety, Tolerability and efficacy of PfSPZ vaccine administered by Direct Venous Inoculation (DVI) to healthy children and infants 5 months through 9 years of age living in an area of high malaria transmission in Western Kenya: Age De-escalation and Dose escalation and a double blind, randomized placebo-controlled Trial for safety and efficacy-Sanaria sponsored study
• A Randomized, Double -Blind Controlled study to Determine the Efficacy of Zinc Supplementation on Diarrhea incidence in an Adult population in Western Kenya..Diarrhea Supplement for Adults -Greater than minimal risk Study.
• A phase 3, Randomized, open-label, Comparative trial of Azithromycin plus Chloroquine versus Mefloquine for the Treatment of Uncomplicated Plasmodium Falciparum malaria in Africa.
• An open Label, 4 escalating dose, Randomized multicentre study evaluating the safety and activity of ferroquine (SSR97193) associated with Artesunate versus a positive calibrator (amodiaquine associated with Artesunate) in African adult patients with uncomplicated Malaria.Malaria Drug Study for Adults -Greater than minimal risk study.
• A Phase I Randomized Placebo-controlled Double-blind Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QuantiFERON-TB Gold (+) and QuantiFERON-TB Gold (-) Adults without Evidence of Tuberculosis TB Vaccine for Adults - Greater Minimal Risk Study

• Jaramogi Oginga Odinga University of Science & Technology, Bachelor of Science Public Health, 2012-2015
• Great Lakes University Kisumu, Diploma Community Health & Development, 2011-2012
• The Eldoret Polytechnic, Certificate in Pharmaceutical Technology, 1999-2000