Clinical Research coordinator | Internal Monitor

• Aug 2016 - Present

Internal Monitoring: The role involves participating in the selection and evaluation of study sites, conducting monitoring visits to ensure protocol compliance and personnel qualification, reviewing regulatory documents to ensure accuracy, verifying consent for subjects before procedures, preparing and submitting monitoring reports, conducting drug accountability visits and inspecting storage areas, identifying and informing investigators of errors or omissions in Case Report Forms (CRFs) and other trial-related documents, monitoring investigator compliance for reporting Adverse Events (AE) and Serious Adverse Events (SAEs), collaborating with external monitors, reviewing monitoring reports with Principal Investigators (PIs) and study coordinators to implement follow-up or corrective actions, reviewing study documentation for completeness and adherence to protocols, and providing guidance and training to research staff on compliance with clinical research regulations and trial details. Study Coordination. The administrative responsibilities involve coordinating with various departments, managing supplies and inventory, hosting visitors, budget management, and facilitating meetings. In the designing of the research program, tasks include regulatory submissions, protocol reviews, designing study tools, assisting with research ideas, and developing work and monitoring plans. The overall conduct of research involves mentoring team members, overseeing recruitment and coordination, supervising field activities, managing regulatory submissions, organizing meetings and workshops, collecting and managing data, preparing reports and publications, ensuring compliance, and maintaining study files and cost tracking. Show less

Clinical Research Associate Trainee

• Nov 2019 - May 2021

A structured on job training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. A structured on job training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Assistant study coordinator

• Jun 2015 - Jul 2016

Enumerator and Research Assistant

• Jul 2007 - Jun 2015