Summary
Overview
Work History
Education
Skills
Continuous Professional Development
Continuous Professional Education And Short Courses
Publications And Papers
Personal Information
References
Timeline
Generic
Janet Musembi

Janet Musembi

Kilifi

Summary

I have 16 years of clinical research experience including coordination of Phase 1, 11, 111 clinical trials and observational studies and 2 years monitoring for Clinical Trials within the Kenya Medical Research Institute- Centre for Geographic Medicine Research Coast (KEMRI-CGMRC) in Kilifi, Kenya.

I am currently a Senior Clinician working with the KEMRI-Wellcome Trust, Kilifi since 01st September 2007. As a lead Clinician I double as a Coordinator and I’m involved in developing and training of new employees on Standard and study specific operating procedures.

I have been involved in Phase 1B, II, III studies in the following studies

1. Malaria challenge studies Namely; CHMI Transmod, CHMI VAC074, CHMI SIKA

2. Malaria Vaccine trials Namely R21/MM VAC 073, R21/MM VAC 078, RTSS Mal 049, RTSS Mal 059

3. Malaria surveillance studies Namely 1000 GENOMEs, Malaria Monitoring, Immunology /SIMS Study, ONA study.

Was also involved in a patient satisfactory survey at the Kenyatta National hospital

I am a Knowledgeable Clinician successful at establishing treatment plans, assessing progress and continuously learning about conditions by completing training, evaluating studies and assessing new medication options. Offering 17 years of related experience.

Overview

19
19
years of professional experience

Work History

Study Clinician

KEMRI/WELLCOME TRUST REASEARCH –KILIFI
Kilifi
09.2007 - Current
  • Study Clinician/Coordinator CHMI SIKA Protocol title. Controlled Human Malaria Infection in Semi-Immune Kenyan Adults. (CHMI-SIKA) CHMI TRANSMOD STUDY-Phase I Trial Protocol Title: Safety and feasibility of a malaria transmission model in semi- immune Kenyan adults using Plasmodium falciparum sporozoites.
  • R21/MM STUDY-Phase I Trial (First in Human Trial) Protocol Title: A Phase 1b, open-label, age de-escalation, dose-escalation study to evaluate the safety and immunogenicity of different doses of a candidate malaria vaccine; adjuvanted R21(R21/MM) in adults, young children and infants in Kilifi, Kenya.
  • VAC 078 STUDY- Phase III Trial Protocol Title: A Phase III randomized controlled multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria.
  • VAC074 STUDY-Phase II Trial Protocol Title: Safety, immunogenicity, and efficacy of R21/Matrix-M and ChAd63/MVA-ME-TRAP in the context of controlled human malaria infection: A Phase IIb Trial in Kenyan Adults.
  • Shigella Challenge Study-Phase I Trial Attending Protocol Development Meetings
  • RTSS/ AS01- Safety and Efficacy of RTSS Malaria Vaccine Phase 2 and phase 2B Among other malaria surveillance studies,
  • In depth, understanding of the study goal’s in order to conduct the study.
  • Development and reviewing SOPS and SSPS
  • Training new employees
  • Perform screening and consenting, enrollment, randomization of participants to treatment arms, issuance of medication and follow up of participants, including medical history, physical examination and applicable data during screening, enrollment, randomization and follow up visits.
  • Clinical management of ill participants and conducting clinical procedures including venipuncture, insertion of intravenous cannulas and collection of biological samples when necessary.
  • Reporting of any Severe adverse events to the Sponsor , and relevant authorities in a timely manner
  • Ensure that all the necessary documentation pertaining to enrollment, follow up, clinical processes, other specific study procedures and operations are documented in the proper manner as provided for and in conformity with good clinical and documentation practice.
  • Clinical data query resolution Community engagement Adequately respond to questions about the study posed by participants and the community.
  • Accurately and completely filling out all study forms. Arrange laboratory tests according to study protocol. Keep records and check study forms for completeness and accuracy each day.
  • Develop an in-depth understanding of the study design and goals. Report problems encountered in the field to the Study Manager.

Clinical Officer

Mbitini Catholic Dispensary
01.2007 - 09.2007

Jan. 07th -Aug. 08, Mbitini Catholic Dispensary, Clinical Officer, Clerkship, physical examination and patient review of patients. Clinical Diagnosis. Interpretation of Laboratory results and Management of the sick patients. Prescription of medication for proper management of the sick. Referral of severe cases to higher levels for specialized management. PITC/VCT services for those in the Outpatient department. Giving health talks in the Mother and child health clinics before reviews. Offering MCH services. Updating the Hospital integrated management system with clerkship information. Attend continued medical education as organized by the hospital management. Performing minor surgeries.

Internship Clinical Medicine & Surgery

Kiambu District Hospital
01.2006 - 12.2006

6TH JAN. 2006 –Dec.06, Kiambu District Hospital, Internship Clinical Medicine & Surgery, Clerkship, physical examination and patient review of patients in different ward rotations. Clinical Diagnosis and conduction of ward rounds under senior supervision. Interpretation of Laboratory results and Management of the sick patients. Prescription of medication for proper management of the sick. Referral of severe cases to higher levels for specialized management. PITC/VCT services for those in the Outpatient department. Giving health talks in the Mother and child health clinics before reviews. Updating the Hospital integrated management system with clerkship information. Attend continued medical education as organized by the hospital management.

Practicals

Machakos General Hospital
11.2004 - 07.2005

Participant in Patient Satisfactory Survey

Kenyatta National Hospital
  • 30TH JAN 2006 –28TH FEB 2006, Kenyatta National Hospital, Participant in Patient Satisfactory Survey
  • Greeted and registered incoming patients in a timely manner.
  • Ensured patient's information was accurately entered into the system.
  • Checked with customers to determine satisfaction with services, promptly taking action to correct problems.

Education

Diploma in Clinical Medicine & Surgery - <ul><li>Medicine</li><li>Surgery</li><li>Health Service Management</li><li>Pharmacology</li><li>Paediatrics</li><li>Obstetrics & Gynaecology</li><li>Community Medicine</li></ul>

Kenya Medical Training College (Nairobi Campus)

Certificate in computer applications -

Inforidge College

Kenya Youth & Orphans Empowerment Programme

Kenya Certificate in Secondary Education -

Muthetheni Girls High School

Skills

  • Outstanding research and information management capabilities
  • Proven ability to work collaboratively with diverse groups and establish ongoing relationships
  • Capable of quickly understanding how systems are used in order to provide efficient support
  • Demonstrated outstanding participants orientation using strong communication skills
  • Strong leadership and management capabilities
  • Extremely dedicated, organized, and a team oriented
  • Excellent Clinician
  • Team player and coordinator
  • Ability to work and deliver under no or minimal supervision
  • Clinical trial monitoring skills
  • Good report writing skills
  • Good verbal communication skills and ability to take initiative
  • Planning and organization skills
  • Networking, liaison, advocacy, community mobilization and partnership building
  • Design, implementation, data analysis and dissemination of monitoring and evaluation and research studies
  • Ability to inspire a shared vision among colleagues, partners and other stakeholders

Continuous Professional Development

  • August 2009, London school of Hygiene and Tropical Medicine, Post graduate Diploma in Clinical trials, Fundamentals of Clinical trials, Clinical trials in practice, Basic Statistics in Clinical trial, Reporting and reviewing of clinical trials
  • October 2011, London school of Hygiene and Tropical Medicine, MSC Clinical Trial, Protocol Development, Trial Designs, Regulatory Affairs, good clinical practice and ethics, Overview and introduction to epidemiology, Data Monitoring and interim analysis, Project Management and research coordination, Integrating Module

Continuous Professional Education And Short Courses

  • Certificate in ICH Good clinical practice E6 23/June/2021
  • Certificate in Data Protection training 14/ June/2021
  • MRC Good research practice 15/June 2021
  • Introduction to Research ethics 17/June 2021
  • Introduction to clinical research 23/June 2021
  • Shigella CHIM Training at Johns Hopkins Research- Baltimore Unit 05/Aug/2022
  • ACLS And BLS American Heart Association 16/Aug 2023
  • Kemri Security and Data protection 13Dec2023
  • Human Subjects Protection CITI program 11Dec2023

Publications And Papers

JCI CHMI/SIKA Paper 2

Personal Information

  • Passport Number: AK0845325
  • Gender: Female
  • Nationality: Kenyan
  • Address 1218-80108, Kilifi

References

  • Melissa Kapulu, Principal Investigator, KEMRI Wellcome Trust, MKapulu@kemri-wellcome.com, 0717501319
  • Juliana Wambua, Project Manager, KEMRI Wellcome Trust, jwambua@kemri-wellcome.com, 0724235784
  • Emmaloise Gathuri, Clinical Research Associate 2, IQVIA East Africa, Emmaloise.gathuri@iqvia.com, 0720766978
  • Esther Kivaya, Senior Clinical Research Associate, IQVIA East Africa, Nairobi, West End Towers Waiyaki Way, Nairobi, P.O Box 1896-00606, 0728821026, Esthernyanje3@gmail.com

Timeline

Study Clinician

KEMRI/WELLCOME TRUST REASEARCH –KILIFI
09.2007 - Current

Clinical Officer

Mbitini Catholic Dispensary
01.2007 - 09.2007

Internship Clinical Medicine & Surgery

Kiambu District Hospital
01.2006 - 12.2006

Practicals

Machakos General Hospital
11.2004 - 07.2005

Participant in Patient Satisfactory Survey

Kenyatta National Hospital

Diploma in Clinical Medicine & Surgery - <ul><li>Medicine</li><li>Surgery</li><li>Health Service Management</li><li>Pharmacology</li><li>Paediatrics</li><li>Obstetrics & Gynaecology</li><li>Community Medicine</li></ul>

Kenya Medical Training College (Nairobi Campus)

Certificate in computer applications -

Inforidge College

Kenya Youth & Orphans Empowerment Programme

Kenya Certificate in Secondary Education -

Muthetheni Girls High School
Janet Musembi