Charles Ezeudu

About Charles Ezeudu

I currently have my Doctorate in Pharmacy (PharmD) from Texas Southern University, Houston Tx. I am a Resourceful Clinical Affairs Specialist with over 4+ years of expertise in clinical research, site and vendor management. Monitors clinical trials by adhering to protocol requirements, identifying problems, and providing targeted solutions. High level of proficiency in Phases I-IV clinical trial, ICH/GCP guidelines and FDA audit requirements.Skills•ICH GCP Guidelines, HIPPA and FDA Regulations•Risk Based Monitoring•AE/SAE Reporting•Detail-Oriented•Strong time management skills•Effective Problem-Solving skills•Knowledge of CTMS/ eTMF: VeevaVault, Medidata Suite•IVRS, and EDC Systems•Excel•Flexible and AdaptableCertifications. •Sterile Compounding and Aseptic Technique IV Certified•APhA Pharmacy-Based Immunized• Bloodborne Pathogens Certification •American Red Cross Basic Life Support•American Heart Association Basic Life Support Certification• Excel Graphing and Data Analysis• PYXIS, CPRS, VISTA, OMNICELL,•Texas State Board of Pharmacy Pharmacist Intern•Texas State Board of Pharmacy Registered Technician

Experience

1. Clinical Affairs Specialist

   Healgen Scientific

   Jan 2023 — Present · Houston, TX, US

   Manage the clinical trial project schedule, documentation, budget and other trial processes to ensure that the clinical development progresses in strict accordance with the plan, the quality meets regulatory requirements, and the costs are reasonable.Carry out the design of clinical trial protocols (including study background, theoretical basis and objective, study methods, etc.) based on product characteristics, regulations and technical guidelines, to meet the requirements of registration and reduce invalid design operations; prepare for other necessary information (e.g, informed consent form).Screen and select appropriate sites based on cost, trial data quality, and schedule, and drive project establishment, ethics review, contract signing, and patient recruitment.Responsible for the preparation of trial materials, training of personnel, monitoring of trial centers and archiving of documents generated from the clinical trials.Statistically analyze and medically interpret trial data to objectively demonstrate the efficacy and safety of the study products; Support other necessary medical writing.

Education

• Texas Southern University

  Doctor of Pharmacy - PharmD, Pharmacy

• Texas Southern University

  Bachelor's degree, Chemistry