ELIZABETH AKINYI OUMA

Phone No. +254 705 882 055

Email; [email protected]

OBJECTIVE

To be a Research Coordinator in an organization where experience and knowledge in Clinical trials, Infectious Diseases, Data management, Monitoring and Evaluation, project management and coordination is needed.

HIGHLIGHTS OF QUALIFICATIONS

·       Health care professional with a degree in community health and development, certificate in computer studies and quality management system, Diploma in Kenya Registered Community Health Nursing(KRCHN) with experience in quality assurance, regulatory submissions, project management, study coordination and data management in the field sites spread within Siaya and Kisumu Counties under Kenya Medical Research Institute(KEMRI) / Centre for Respiratory Diseases Research(CRDR)/Centre for Disease Control (CDC).

·       Experience in monitoring and evaluation of project activities to ensure the overall goal is achieved through planning and implementation of the activities in line with the required timelines.

·       Experience in organizing trainings for staffs and non-staffs and periodic feedback meetings with different stakeholders involving the ministry of health and various NGOs.

·       Experience in quality management system with knowledge in; developing and maintaining Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs), analyzing problems and finding innovative solutions.

·       Proven ability to motivate and work effectively with people through being flexible, team player, adoptable, self-driven and perfectionist character of being detailed oriented in all that I do.

·       Experience in data management with high level of computer literacy both in MS Word, access, excel, power point, SPSS and outlook.

SKILLS AND ACCOMPLISHMENTS

·       Managed and coordinated various clinical trials studies including TB vaccines trials(both infant and adult), Malaria and Sickle cell drug trials and Tuberculosis (TB) epidemiological studies in Siaya County and ensuring regular updates to the Sponsor, Principle investigator and study staffs, training of staffs, study planning, review of budget and adequate and timely provision of the project resources.

·       Organized and conducted feedback meetings with the Stakeholders and communities participating in the project.

·       Prepared and reviewed weekly and monthly work plans and developed monthly, quarterly and yearly progress reports which were distributed/submitted to the stakeholders and staffs and the Intuitional Review Boards (IRBs).

·       Conducted quality control for all the studies within the project and ensured data completion, remote data entry, data cleaning and storage according to the unit standard operating procedures.

·       Conducted training and orientation for the new staffs and refresher training for staffs during annual conference.

PROFFESSIONAL EXPERIENCE

Mar 2019 – To Date; KEMRI-UNIVERSITY OF WASHINGTON

Position:  Project Coordinator Toto Bora (AZM) Trial

Responsibilities

·       Coordinate study activities at the study site to ensure smooth implementation of the study.

·       Training staff members on operational policies and procedures, SOPs, Protocol and filling of the CRFs.

·       Monitor study sites to assess compliance with protocol, sponsor, GCP.

·       Compile monthly report on the administration of the study.

·       Compile quarterly, Bi -annual and annual progress reports for submission to the ethics committees

·       Data management, cleaning and tracking.

·       Conduct internal monitoring and tier 2 QA/QC on the participant files.

·       Scout for new sites and spear head the talks as well as implementing study activities there.

·       Participate in teleconference / Skype calls as required to update the leadership on the study progress / status.

·       Timely reporting of AE/SAEs.

·       Communicate with the Institutional Review Boards (IRBs) regarding document submissions, review and approval.

·       Lead the study team in resolving site monitoring visits findings.

2016 – Feb 2019;  KENYA MEDICAL RESEARCH INSTITUTE/ CENTRE for RESPITRATORY DISEASES RESEARCH (KEMRI/CRDR)

Position:  Study Coordinator / QA Manager

·       Network and collaborate with governmental and non-governmental organizations (NGOs, CBOs, FBOs) involved in the projects.

·       Monitoring and evaluation of project activities, Conduct internal monitoring for the studies within the project.

·       Planning and implementation of project activities.

·        Develop and manage the project budget

·       Develop and review weekly and monthly work plans

·       Creating and maintaining Trial Master files (TMFs) for all the clinical trials within the project.

·       Communicating with the institution’s review board and regulatory authorities on behalf of the Principal Investigator to ensure necessary local ethics review board approvals and renewals are obtained for the study and managing study ethics and human subject protection (both local and international).

·       Write site specific addendums for the upcoming protocols.

·       Acting as the liaison person between the site and the study sponsor / clinical research associates to communicate study progress and activities, prepare the site for new studies / upcoming studies.

·       Overseeing the implementation of study protocols and the trial conduct throughout the study period to ensure that the site adheres to the study protocol/ ICH /GCP guidelines and the applicable regulatory rules.

·       Overseeing the development and review of Standard Operating Procedures ensuring that the documents meet the ICH-GCP, study protocol and local regulatory requirements.

·       Providing regulatory advice and guidance to the study team. Adhere and comply with the requirements for KEMRI ethics committee (SERU), Kenya Pharmacy and Poisons Board (KPPB), Food and Drug Administration (FDA) and ICH GCP guidelines throughout the study implementation.

·       Coordinating the development of the study protocol, data collection tools and training of the study staff, and monitor the progress.

·       Conduct training and orientation of the new staffs, implement capacity-building efforts to increase and expand the skills of local counterparts and field team technicians. Also do refresher training for staffs during annual conference.

·       Maintain the training records and track online GCP staff trainings to ensure timely reminders for the renewals that are due.

·       Liaise with the recruitment team for community sensitization, mobilization and dissemination study results if and when required.

·       Scout for new sites and spear head the talks as well as implementing study activities there.

·       Participate in teleconference / Skype calls as required to update the sponsors and external collaborators on the study progress / status.

·       Attend investigators meetings on behalf of the site and give feedback.

·       Develop and maintain study subject screening, enrollment, serious adverse event and protocol deviation logs.

·       Assisting and coordinating of the site monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors. • Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.

·       Create and develop materials (CRFs /Questionnaires) for each clinical trial protocol and ensuring their availability for subject enrollment.

·       Develop, implement and evaluate Clinical Quality Management Plan.

·       Perform Source Data Verification (SDV) on the electronic case report form visa vi source data / case report form for data consistency and validity.

·       Manage and supervise both the clinical and field-based (community interviewers) team to ensure adherence to SOPs for participant enrolment and monthly follow ups.

·       Prepare study monthly and quarterly reports and submission of the same to the Principal Investigator in a timely manner

·       Oversee the procurement and inventory supplies and equipment’s for the study. Ensure that necessary supplies/materials are in stock for study implementation.

·       Providing oversight of study advisory board (CAB)

·       Coordinate and participate in the data analysis and report writing activities.

·       Assist with site selection activities, including site qualification visits.

·       Assure study site adherence to the protocol, GCP, procedural documents and recommend necessary actions to bring about compliance or improve processes.

·       Anticipate/identify potential problems, implement corrective and preventive actions and escalate where appropriate sites.

·       Develop and implement Serious Adverse Event (SAE) SOP for proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) per protocol. Ensure SAEs, safety update reports and other new information or sponsor reports are provided to and received by the sites for reporting to ethics, as needed.

·       Ensure all Serious Adverse Events (SAE) reports are reviewed, signed off by the responsible physician and filed within required timelines.

·       Preparation of study research reports

·       Perform any other duties as assigned.

2010-2015: KENYA MEDICAL RESEARCH INSTITUTE / CENTRE FOR DESEASE CONTROL (KEMRI / CDC).

Position: Nurse quality control officer / Deputy QA manager

·       Lead quality control officer in randomized double blinded clinical TB vaccine trial named AERAS 402 study.

·       Provided QA oversight for TB epidemiological study in both infant and adolescent cohorts. Ensured that the site conducted the trial in accordance with the protocol/ICH GCP guidelines and ensured extreme confidentiality of patient’s information and documents.

·       Organized continuous medical education for the site staff.

·       Prepared and compiled documents for submission to the ethics committee

·       Reviewed and version controlled standard operating procedure manuals (SOPs) and case report forms (CRFs).

2005 -2010; Deputy Nurse in charge of maternity ward at The Moi Teaching and Referral Hospital.

Responsibilities:

·       Provided excellent and quality nursing care to mother and baby care in the maternity unit

·       Provided health education to the in patients

·       Administered prescribed treatment to admitted patients

·       Maintained minimum and maximum stock levels to ensure steady supply of consumer bales in the maternity wing

·       Developed and implemented nursing care plan for patients prioritizing their needs

·       Took charge of the shifts and reported to the chief nursing officer.

·       Mentored junior nursing officers and patient attendants in the maternity wing

·       Made and balance duty rosters and staff allocation for adequate coverage.

Date: January 1999 – December 2004

Organization: Marie Stopes Kenya

Job Title: Centre Manager

As the Centre manager I oversaw the operations of both clinic and outreach services in one of centers. During my tenure the Centre manager I was voted one of the best managers and my clinic had the best performance in terms of income to cost and couple’s year of protection.

My roles were as follows:

·       Planning, organizing, implementing, coordinating, monitoring and evaluating clinical services.

·       Human resource management

·       Organizing for maintenance and proper usage of Marie Stopes equipment’s under my care. Marketing of health services and Marie Stopes facilities in areas of jurisdiction in relation to its organizational objectives.

·       Write monthly and quarterly performance reports

·       Performance staff appraisals

·       Work hand in hand with the leadership to advance Marie Stopes agenda

·       Financial management of the Centre.

EDUCATION AND TRAINING

2015 to date: MPH: (On going): Master of Public Health at Jaramogi Oginga Odinga University of Science and Technology.

2012 to 2015: B.Sc. (First class Hons): Community Health and Development at Jaramogi Oginga Odinga University of Science and Technology.

1995 to 1998: Diploma: Kenya Registered Community Health Nurse at Kenya Medical Training College

Secondary School Education:  Aluor Girls’ Secondary School

Qualification: Kenya Certificate of Secondary School Education, (KCSE)

Primary School: Segere Primary School

Qualification: Kenya Certificate of Primary Education (KCPE)

SEMINARS AND TRAININGS

MAR 2019                              Certificate on Collaborative Initiative Training Institution (CITI)

JUL 2014                                Certificate on Quality Management System

JUN 2013                                Certificate on successful completion of training on Quality System, Good Clinical Practice (GCP), Good Clinical Laboratory (GCLP) Practices and Annual safety training.

REFEREES

1. Name: Hellen Awuoche

Organization: KEMRI / CGHR

Position: Data Manager

Mobile   No. +254 780445855

Email address: [email protected]

2. Name:  Patience Odwuor

Position; Study Coordinator

Organization: University of Maryland

Mobile No. +254719841674

Email: [email protected]

3. Name; Clementine Mbaatha

Position: Clinical Instructor

Organization: The Moi Teaching and Referral Hospital

P.O    BOX    3.

Eldoret.

Mobile No. +254 7227426529

Email address: [email protected]