Chinweuju Obi

About Chinweuju Obi

Senior Clinical Research Associate with over 7 years ofexperience managing and coordinating Phase I–IV clinical trials acrossoncology, ophthalmology, dermatology, cardiovascular,endocrine/metabolic, CNS, surgical, and medical device studies.Recognized for ensuring strict protocol adherence, contributing to a 30%reduction in protocol deviations, and aligning with FDA, ICH-GCP, ISO,and Investigational Device Exemption (IDE) regulatory standards whileconsistently delivering studies on time and within budget.Proven experience acting as a sponsor representative forpharmaceutical, diagnostic, and medical device companies conductingindependent sponsor oversight visits, implementing pharmaceuticaltrials, and performing comprehensive clinical monitoring to ensure dataintegrity and patient safety. Demonstrated expertise in outcome researchstudy design, statistical analysis, and the Design of Experiments(DOE) for evaluating clinical outcomes.Skilled at building strong, collaborative relationships with sponsors,investigators, and multidisciplinary teams while overseeing participantenrollment, informed consent, and safety monitoring. Experienced in alltypes of monitoring visits, leveraging expertise in EDC systems, sitemanagement, and regulatory compliance to ensure audit readiness.Committed to advancing medical research with precision, integrity, and apatient-focused mindset.Key Achievements Improved site readiness by 25% through proactive monitoring. Ensured zero audit findings across multiple clinical studies. Supported successful database locks across multiple trials. Delivered 100% of monitoring visits on schedule with high quality documentation.

Experience

1. Senior Clinical Research Associate

   Ppd

   Aug 2022 — Present

Education

• National Open University of Nigeria (NOUN)

  Master's degree, Information Technology

• Enugu State University of Science and Technology

  Bachelor of Engineering - BE, Computer Engineering