Stella O.

About Stella O.

As a dedicated Clinical Research Professional, I am driven by a deep passion to enhance…

Experience

1. Clinical Research Trainee

   Meridian Bioscience Inc.

   Feb 2024 — Present · US

   I was trained in International and Regulatory Standards: Mastery of ICH GCP E6 R(2) guidelines, FDA regulations (21 CFR Parts 11, 50, 54, 56), and the Common Rule (45 CFR 46), ensuring compliance and ethical conduct in global clinical trials.Data Management: Skills in managing trial data with accuracy, completeness, and reliability following GDP and ALCOA-C principles, including identifying and reporting AEs and SAEs.Clinical Trial Operations: Insights into the entire clinical trial lifecycle, from feasibility to close-out, with a focus on the Informed Consent Process to protect participant rights and well-being.Quality Assurance and Monitoring: Strategies for quality assurance, trial monitoring, and effective query resolution to uphold research integrity and quality.Protocol Comprehension and Execution: The capability to accurately understand and execute clinical trial protocols, adhering to specified objectives and methodologies.Regulatory Documentation: Proficiency in maintaining regulatory binders and managing essential clinical trial documents like Form FDA 1572, Delegation of Authority logs, training records, and other ISF documents, ensuring audit readiness and compliance.