Gloria Nwachukwu

Oversees and manages clinical trial start-up activities, including site selection, regulatory document collection, IRB/EC submissions, and contract negotiations to ensure timely study initiation. Leads the planning, execution, and management of clinical trials from start-up to closeout, ensuring adherence to timelines, budgets, and regulatory requirements.

Oversaw the planning, execution, and completion of clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Coordinated and managed multiple clinical trial sites, including site selection, initiation, monitoring visits, and close-out activities.

Assisted in reviewing data quality reports for trends and escalation of monitoring issues. Conducted Oversight Visits to assess CRA and/or site performance to evaluate data integrity, compliance with the protocol, Good Clinical Practice (GCP), and any applicable local/regional regulations.

Developed and maintained strong relationships with investigators, site staff, and key stakeholders to ensure high levels of engagement and trial performance. Conducted training sessions for site personnel on protocol requirements, investigational products, and study procedures.

Responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, and the conduct of pre-study and initiation visits. Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements were adhered to according to the applicable regulatory requirements.

Assisted in site selection, initiation, routine monitoring, and close-out visits under supervision. Ensured that clinical trial sites followed the study protocol, GCP guidelines, and regulatory requirements.

Maintained accurate and up-to-date study records, including case report forms (CRFs), source documents, and regulatory files. Ensured compliance with Good Clinical Practice (GCP), FDA regulations, Institutional Review Board (IRB)/Ethics Committee (EC) guidelines, and sponsor requirements.

Currently pursuing a Doctor of Public Health degree. This advanced program focuses on public health principles and practices.

Completed a Master of Public Health program, gaining expertise in public health methodologies and applications. The curriculum covered various aspects of public health, preparing for advanced roles in the field.