Charlene Nwajei

Clinical Research Coordinator Ivf Coordinator @Care Fertility

Bedford, TX, US

Study Management: Oversee the day-to-day activities of clinical trials, including recruitment, screening, and enrollment of study participants.Regulatory Compliance: Ensure adherence to GCP (Good Clinical Practice), ICH (International Council for Harmonisation), and FDA regulations, as well as institutional and sponsor-specific protocols.Data Collection & Documentation: Manage accurate and timely data collection, documentation, and reporting in compliance with regulatory requirements in EMR systems such as Digital MD (DOC), FERT, Athena Health, IRT, and Calyx.Participant Interaction: Act as a liaison between study participants, clinical staff, and sponsors. Provide informed consent to participants and answer questions regarding the study.Coordination with Investigators: Work closely with principal investigator and other research team members to ensure smooth study operations. Schedule and attend study meetings, tracking the progress of the clinical trials.Monitor Study Compliance: Assist with scheduling site visits as needed, provide any necessary documentation to study monitors, and quickly resolve any queries initiated by monitor during site visit.Inventory Management: Track and manage clinical trial supplies, ensuring that study medications, equipment, and resources are available as required.