Sean Ndubuisi

Experience

1. Senior Clinical Research Associate

   Ppd

   Aug 2018 — Present · US

   Performs day-to-day operations of clinical trials, including site selection, site initiation, interim monitoring, site management and close-out visits (on-site and remotely) ensuring regulatory, Good Clinical Practices (GCP), protocol compliance and that data passes quality assurance audits. Performs and coordinates all aspects of clinical monitoring and site management process for assigned sites per ICH-GCP, local regulations, and PPD SOPs. Serves as primary contact for assigned research sites. Uses judgment and experience to evaluate overall performance of site and site staff and provides recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develops action plans. Ensures site IRB approval is current and all IRB documentation are in order. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements, and supports EDC user acceptance testing and training as applicable. Performs drug accountability and reconciliation, and verifies that drug storage meets protocol and SOP requirements. Routinely reviews Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF) and ensures the investigator site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan. Mentors and provides guidance to junior/entry level CRAs.

Education

• University of North Texas

  Master's degree, Clinical/Medical Laboratory Science/Research and Allied Professions

• Texas A&M University-Corpus Christi

  Bachelor of Science - BS, Nursing