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CV Profile No.44057

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Profile details

Job category searched
» Health and social professions
» Management
» R&D, project management
Professional experience
More than 10 years
» Education, training
» Health, pharmacy, hospitals, medical equipment
» Quality, methods
» Research and development
» Social, public and human services
Professional Experience: 
Since 05.2013
Technical Advisor, Regulatory Affairs and Personnel Training
CMR KEMRI; SEARCH Study
I have advised on, coordinated and documented all Regulatory processes and procedures including tracking protocols and SOPs, internal quality audits and inspections, ethical approvals and permit applications and renewals and PPB applications. We successfully implemented the test- and-treat model of HIV care and treatment. My functions included: 1. Support with development and oversight of Clinical Development Plans 2. GCP expert/consultant -- provide expertise, support, and/or respond to questions from personnel 3. In-house CRA -- Planning and conducting internal research monitoring & evaluation 4. Established and maintained a system for identifying potential problems, recommending and/or implementing corrective and preventive actions (CAPAs) 5. Communication -- Responding to Sponsor requests through the UCSF and monitors 6. Analyzing research protocols and interpreting them for the study team prior to submission or scientific and ethical approval, including annual renewals 7. Consultation and Advice to other individuals and departments -- Providing guidance and expert advice to the study management 8. Developing and Building Teams -- Encouraging and building mutual trust, respect, and cooperation among research team members through meetings and caucuses
07.2008 - 06.2013
Quality Assurance/Quality Control Coordinator
CMR KEMRI; Partners PrEP Trial
1. Worked successfully with visiting FDA Auditors in May 2012; the study got a positive FDA Audit report for the leading to approval of Truvada for PrEP 2. Maintaining liaisons with the PI and Study Managers to ensure proper and timely scientific/ethical submissions to applicable IRBs including review and preparation of appropriate responses for re-submission as applicable 3. Oversight of regulatory compliance and quality assurance/quality control (QA/QC) 4. Reporting and report writing – monthly/quarterly and annual reports to approving agencies and coordinating centre at the University of Washington 5. In-house CRA for the Partners PrEP Trial, Kisumu site 6. Working with external monitors during site monitoring visits to review clinical data for accuracy, completeness and discrepancy resolution 7. Timely response and appropriate follow-up on monitoring visit reports/issues 8. Assured study site adherence to the protocol, GCP, Operational Procedure Manuals; suggested necessary action to spur continuous and continual quality improvement 9. Development and review of Standard Operating Procedures (SOPs) 10. Part of the site initiations team together with other study teams. Also actively involved in monitoring, close-out and archival activities in adherence with applicable regulatory and KEMRI/SERU SOPs and Sponsor requirements.
Skills
Excellent analytical abilities -- I utilize my Bioethical, Regulatory and Human Rights knowledge to ensure compliance with the protocol, applicable SOPs and regulatory requirements, An effective attention to the finer detail in order to successfully oversee regulatory initiatives, Critical Thinking -- I use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to research and site problems, Problem/Risk Sensitivity -- Able to recognize when something is wrong or is likely to go wrong, Deductive Reasoning -- Able to apply general rules to specific problems to produce answers that make sense, Inductive Reasoning -- Able to combine pieces of information to form general rules and to find a relationship among seemingly unrelated events, Strong and Effective Communication -- both in written and verbally; an active listener, Systems Analysis and Evaluation -- Able to determine how a system should work and how changes in conditions, operations, and the environment can affect outcomes. Also able to identify measures or indicators of system performance and the actions needed to improve or correct performance, relative to the set goals
Education
Master
11.2008 - 09.2010
Project Planning and Management
University of Nairobi
Pursued Courses leading to effective designing, planning and implementation of projects and programs, including: Project M&E Management Information Systems Research Methods/Project Gender Issues in Development Social change and Community Development Civil Society Organizations, etc
Since 04.2019
Masters Degree in Global Bioethics (MDGB)
Universidad Anahuac, Mexico
In this Training, the focus is on ensuring a unified approach towards Bioethics across the globe
10.1997 - 11.2001
BSc. Nursing
University of Nairobi
Nursing care and management
Languages
englishfluent
More information
in 1 month
Nairobi - Nyanza - Rift Valley - Western - International
Place of residence : Kisumu
Permanent contract - Fixed-term contract - Freelance
18.09.2020
18

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