Teresia Nganga

Senior Clinical Research Associate @Seagen

Atlanta, GA, US

Contributes to the development of standard operating procedures (SOPs) for monitoring and quality control.• Conducts root cause analysis of data discrepancies, collaborating with data management teams for resolution.• Presents study progress updates and findings to sponsors and stakeholders during routine meetings.• Participates in vendor selection and management for central laboratory services and electronic data capture systems.• Collaborates with medical monitors to assess participant safety and manage adverse event reporting.• Supports the development and implementation of risk mitigation strategies, adapting to changing trial conditions.• Coordinates with investigational sites to ensure timely and accurate completion of source data and CRF entries.• Provides guidance on protocol-specific procedures and ensured adherence to ICH-GCP guidelines.• Manages study budgets and timelines for global Phase trials, optimizing site performance and patient enrollment.• Coordinates with regulatory affairs to prepare and submit documentation for ethics committee and regulatory approvals.• Mentors new CRAs in study procedures, data collection, and effective communication with investigative sites.• Identifies protocol deviations and implemented corrective actions, ensuring data integrity and participant safety.

Grand Canyon University

Bachelors, Registered Nursing/Registered Nurse

Western Governors University

Master's degree, Data Analytics

NIDA Clinical Trials Network

Good Clinical Practice, Clinical Research

Kenya Medical Training College

Associate's degree, Registered Nursing