Chindah Amadi Email & Phone Number

Houston, Texas, United States

• Collaborate with clinical research teams to design and implement study protocols.• Conduct patient screening and enrollment for clinical trials.• Obtain informed consent from study participants while adhering to ethical guidelines.• Execute data collection procedures and maintain accurate study records.• Monitor study progress and ensure compliance with regulatory requirements.• Coordinate study visits and manage participant schedules.• Conduct site visits to ensure protocol adherence and data accuracy.• Act as a liaison between study sites, sponsors, and regulatory authorities.

Berlin, Germany

• Developed and managed protocols for clinical trials, ensuring adherence to regulatory requirements including ICH-GCP, local regulations, and ethical standards.• Coordinated with investigators, sponsors, and regulatory authorities to facilitate study initiation, monitoring, and closeout activities, ensuring sites were prepared for study initiation and provided ongoing support to maintain study conduct.• Conducted patient recruitment, screening, and enrollment, maintaining accurate and complete study documentation and ensuring patient safety and confidentiality throughout the study process.• Collaborated with multidisciplinary teams to analyze study data and prepare reports for presentation and publication.Achievements• Implemented protocol amendments following regulatory requirements and study sponsor directives, ensuring study integrity. Achieved 100% compliance with protocol amendment timelines, reducing protocol deviations by 25%.• Managed study timelines and milestones, ensuring timely completion of study activities and reporting. Improved study completion rates by 20% through effective timeline management.• Supported data management activities, including data cleaning, validation, and reconciliation, ensuring data quality and integrity. Reduced data discrepancies by 30% through meticulous data management practices.

Netherlands

• Led the coordination of multiple clinical trials, including protocol development, study initiation, and monitoring, ensuring studies were conducted in compliance with regulatory requirements, scientific standards, and sponsor expectations.• Implemented quality control measures to ensure data integrity and regulatory compliance throughout the studies, and conducted regular monitoring visits to assess study conduct and compliance with study procedures.• Developed and maintained strong relationships with study sites, investigators, and sponsors to support successful trial execution, through regular communication with stakeholders to provide updates and address issues proactively.• Managed study budgets and resources effectively, optimizing operational efficiency and cost-effectiveness, identifying and mitigating potential risks to study completion.Achievements• Increased participant recruitment rates by 54% through targeted outreach and screening processes. Implemented recruitment strategies that resulted in a 54% increase in participant enrollment, exceeding recruitment goals.• Ensured proper documentation of study-related activities and maintained audit-ready files, facilitating inspections and audits. Achieved 100% compliance with documentation requirements, leading to successful inspections and audits.• Implemented resource optimization strategies, such as centralized monitoring and risk-based monitoring, to improve study efficiency and reduce costs. Reduced study costs by 15% through effective resource optimization strategies.

Ukraine

• Oversaw the planning and execution of cardiovascular clinical trials, ensuring adherence to study protocols and regulatory requirements, and coordinating with internal and external stakeholders to achieve study objectives.• Conducted training sessions for site staff on study protocols, data collection, and reporting procedures, providing ongoing support and guidance to ensure site compliance and data quality.• Contributed to the development of new research proposals and grant applications, demonstrating a proactive approach to advancing clinical research.• Implemented a streamlined process for study visit scheduling, reducing wait times by 67%.