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Naomi Kamau Clinical Trial Coordinator

New york, Ontario
able to work in a multi-cultural environmentpunctual and high integrity

Professional Profile
I am currently working as a study Coordinator in the Yellow Fever study where I have developed skills in co-ordinating a clinical trial by taking up roles such as Regulatory roles, Quality Check and Quality Assurance, Study impress and participant reimbursement, developing SOPs for our upcoming study as well as Representing the team in the monthly Clinical Trials Facility monthly meetings.

I have also had an opportunity to work as Study Nurse in other studies such as FLACSAM, TACT II, COAST and NEOFOSFO studies in the KEMRI High Dependency Unit. This has greatly broadened my capacity to work with clinical trials.

 

 

 

CONTINUOUS PROFESSIONAL DEVELOPMENT
IT Security and Data Protection training

29th August 2019.

Venue: Kemri-Wellcome Trust Kilifi.

 

Enrolled in an online course in Project Management-University of Washington

July 2019-September 2019

Venue, Kemri-wellcome trust Kilifi

 

Clinical Management of HIV/AIDS- University of Washington (Online course)

From March 2019 – June 2019.

Venue; Kemri-Wellcome trust, Mtwapa boardroom

 

Basic Life support (BLS) by the Red Cross Society of Kenya

From 5th -6th February 2019

Venue: KEMRI- Wellcome trust

 

Good Clinical Practice – the Global Health Network online course

15th December 2017

Venue: KEMRI –Wellcome trust

 

Research Ethics Course- The Global Health Network online course

20th December 2019

Venue: Kemri-wellcome trust

 

MSM and MARPS sensitization Training

30th September 2018,

Venue:  Kemri-wellcome trust boardroom Kilifi

 

Advanced Cardiac Life Support (ACLS)Trained by the Red Cross Society of Kenya

From 3RD -8TH May 2016

Venue:  resource centre Aga Khan hospital- Mombasa.

 

Education

September 2017- to Date Bachelors of science in Nursing at Kenya Methodist University

In progress, to Graduate in November

29th September 2009 to March 2013 Diploma in Community Health Nursing at Kenya Medical Training College

Completed successfully with a Distinction.

February 2004- November 2008 Kenya Certificate of Secondary Education at St. Johns secondary school-Bahati

Completed with a mean grade of C+ of 51 points

Experience

January 2019 to date Trial Coordinator Yellow fever trials at Kenya Medical Research Institute

General co-ordination Responsibilities:
1.Regulatory role:
• Ensure that the Investigator’s ISF contains essential applicable items and all the required regulatory documents as outlined in the policies.
• File all essential documents in sponsor-supplied Investigator Study File (ISF), and compile any outstanding documents
• Provide original and updated curriculum vitae, GCP and Ethics certificates of all study personnel/Investigators involved, as per the sponsor requirements.
• Ensure that all relevant study site personnel fill out the Site Personnel/Signature Log and Training Log
• Ensure that all study personnel or staff involved in the study activities fill in the delegation logs and understand their roles in the study
• Assisted in the preparation of some of the documents required by the Regulations Authorities, such as application for shipment of biological sample letter to SERU.
2. Quality Control and Quality assurance
• Ensure All study activities are accomplished according to the protocol and applicable regulatory regulations
• Ensure that Subjects sign the correct version of the consent form before any study-related procedures are carried out.
• Data collected in the Case Report Form (CRF) are supported by source documents and that all the CRFs are well completed.
• Ensure Adverse events are reflected in the source documents and captured in the CRF.
• Biological samples are being obtained, handled, stored, and shipped appropriately
3. Impress
• Ensure availability and proper use of the study impress to facilitate smooth running of study
activities.
• Reimburse participants for travel required to attend screening and to attend for vaccinations and follow up.

December 2017 to December 2018 Research Nurse Yellow fever trial at Kenya Medical Research Institute

KEMRI-WELLCOME TRUST
TRAIL COORDINATOR-YELLOW FEVER TRIAL
From January 2019 to date.
Achievements:
I have been able to officially take up general co-ordination activities in the Yellow fever study which has greatly increased my capability to co-ordinate and facilitate the smooth running of a clinical trial.
General co-ordination Responsibilities:
1.Regulatory role:
• Ensure that the Investigator’s ISF contains essential applicable items and all the required regulatory documents as outlined in the policies.
• File all essential documents in sponsor-supplied Investigator Study File (ISF), and compile any outstanding documents
• Provide original and updated curriculum vitae, GCP and Ethics certificates of all study personnel/Investigators involved, as per the sponsor requirements.
• Ensure that all relevant study site personnel fill out the Site Personnel/Signature Log and Training Log
• Ensure that all study personnel or staff involved in the study activities fill in the delegation logs and understand their roles in the study
• Assisted in the preparation of some of the documents required by the Regulations Authorities, such as application for shipment of biological sample letter to SERU.
2. Quality Control and Quality assurance
• Ensure All study activities are accomplished according to the protocol and applicable regulatory regulations
• Ensure that Subjects sign the correct version of the consent form before any study-related procedures are carried out.
• Data collected in the Case Report Form (CRF) are supported by source documents and that all the CRFs are well completed.
• Ensure Adverse events are reflected in the source documents and captured in the CRF.
• Biological samples are being obtained, handled, stored, and shipped appropriately
3. Impress
• Ensure availability and proper use of the study impress to facilitate smooth running of study
activities.
• Reimburse participants for travel required to attend screening and to attend for vaccinations and follow up.

KEMRI – WELLCOME TRUST
STUDY NURSE-YELLOW FEVER STUDY
December 2017 to 30th December 2019
Nursing Responsibilities in the Yellow fever study:
• Identify and Recruit eligible participants from those who volunteer to participate in the programme.
• Getting informed consent from the participants willing to participate in the Programme.
• Collect blood samples and ensure proper labelling and storage as well as transporting them to the Microbiology laboratory within the recommended duration.
• Carry out pregnancy tests to all female participants which is part of the inclusion criteria as stipulated in the Protocol.
• Post vaccination monitoring of Participants.
• Providing professional response to participant’s questions and concerns in relation to the vaccine and the Yellow fever vaccine trial.
• Informally undertaking coordination roles in the trial.

THE AGA KHAN HOSPITAL, MOMBASA.
REGISTERED COMMUNITY HEALTH NURSE,
From May 2014 to November 2017.
Achievements:
December 2016: I Was Trained as a Diabetic Educator and with the support of the Management, Being the Team Leader Formed a Diabetic Support Group in the Hospital, which has been recognized and embraced throughout the region.
In February 2017: I was promoted to work as the acting manager in the Aga Khan hospital Changamwe outreach centre which strengthened my management, communication and team work spirit.
Responsibilities:
• Collaborate with Top Management, interdisciplinary teams and other stakeholders in order to develop, implement and evaluate programs and services within the facility
• Timely submission of monthly data to Hospital Management as well as Ministry of Health. The data includes accidents, incidents and near misses, number of patients, lab and pharmacy performance
• Ordering and overseeing inventory of unit supplies within the facility
• Provide leadership and guidance to a team of seven members of staff, fostering teamwork and collaboration.
• Address any personnel issues to promote a productive and supportive work environment
• Consistently promote the betterment of staff and patient well-being and satisfaction.
• Managing facility’s petty cash by ensuring accountability
• Maintain patient’s medical records ensuring confidentiality
• Timely and appropriate response to requests and concerns.
• Apply evidence-based healthcare practices and nursing standards.
• Providing and monitoring quality nursing care to patients.

• Identify and Recruit eligible participants from those who volunteer to participate in the programme.
• Getting informed consent from the participants willing to participate in the Programme.
• Collect blood samples and ensure proper labelling and storage as well as transporting them to the Microbiology laboratory within the recommended duration.
• Carry out pregnancy tests to all female participants which is part of the inclusion criteria as stipulated in the Protocol.
• Post vaccination monitoring of Participants.
• Providing professional response to participant’s questions and concerns in relation to the vaccine and the Yellow fever vaccine trial.
• Informally undertaking coordination roles in the trial.

march 2014- November 2017 Clinical Nurse at Aga Khan Hospital-Mombasa

• Collaborate with Top Management, interdisciplinary teams and other stakeholders in order to develop, implement and evaluate programs and services within the facility
• Timely submission of monthly data to Hospital Management as well as Ministry of Health. The data includes accidents, incidents and near misses, number of patients, lab and pharmacy performance
• Ordering and overseeing inventory of unit supplies within the facility
• Provide leadership and guidance to a team of seven members of staff, fostering teamwork and collaboration.
• Address any personnel issues to promote a productive and supportive work environment
• Consistently promote the betterment of staff and patient well-being and satisfaction.
• Managing facility’s petty cash by ensuring accountability
• Maintain patient’s medical records ensuring confidentiality
• Timely and appropriate response to requests and concerns.
• Apply evidence-based healthcare practices and nursing standards.
• Providing and monitoring quality nursing care to patients.