Highlights:

Skills:Clinical Research, Pharmaceuticals, Clinical Informatics, Pharmacovigilance

Goal:•Develop a strong understanding of regulatory affairs issues in clinical research and trials •Gain in-depth exposure to the pharmaceutical industry so as to understand drug discovery, global pharmaco-vigilance and pharmaco-economics

Membership:Association of clinical Research Professionals International Society of Sustainability Professionals

Certification:Global Mental Health – University of Washington, 2021 Good Clinical Practice (NIDA Clinical Trials Network) Certified, 2022 Extracorporeal Membrane Oxygenation, Certified, 2022 Basic Life Support, Certified 2022 Analyzing and Visualizing Data with Microsoft Power BI, 2023

Clinical Research Study Coordinator April 2023 - August 2023
The Karen Hospital, Nairobi, Kenya
Industry: Healthcare
•Low INR to Minimize bleeding with mechanical valves trial (LIMIT). •Randomized double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular diseases (VICTORION-2 PREVENT). •Prospective Evaluation of the safety and efficacy of cardiac pacemaker reuse in low to middle-income countries.
•Creating clinical project documents according to the protocol and monitoring Standard Operating Procedures (SOPs) •Conducting monitoring visits to confirm Good Clinical Practice (GCP) protocol compliance •Performing investigative document reconciliation, requesting updated documents and reviewing for consistency and compliance with ICH guidelines and project SOPs. •Administration of informed consent to participants •Assisting with the preparation of IRB applications •Monitoring the safety of participants and ensuring their compliance with the study protocol--