Opeyemi Onabajo

Clinical Research Coordinator Ii @MedStar Health

Washington, DC, US

Attended all required monitoring visits for all studies as assigned including the Pre-Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits developing knowledge of the lifetime of a study. — Monitored and conducted research study adhering strictly to the protocol complying to International Conference on Harmonization (ICH), Good Clinical Practices (GCP) and regulatory requirements to ensure protection and ethical treatment of all patients in all studies. — Received and monitored the accountability of investigational products (IP), study articles from sponsor and inventory test articles working with research pharmacists storing investigational supplies according to Food and Drug Administration regulations and sponsor requirements. — Managed all monitoring, regulatory and data entry responsibilities ensuring the accuracy and completeness of all site records including EDC data entry, Query/Alert resolution, and Essential Documentation organization of physical study binder and electronic study folders. — Attended investigator meetings as appropriate and communicated relevant, updated information as presented to the research team and feedback to the respective CROs and Sponsors. — Assessed and ensured research participant safety throughout study participation and reported all safety events including adverse events and serious adverse events to respective CROs, Sponsors, Safety Teams, and IRB. — Developed effective recruitment plans, discussed study protocol, and educated research participants about study involvement to obtain informed consent, to meet with research participants for each visit and to maintain accessibility for any questions or concerns regarding the study. — Trained to simultaneously monitor 10+ clinical studies of varying therapies in the following specialties: Cardiology, Oncology, Dermatology, Endocrinology, Infectious Diseases, Urogynecology, Women’s Health, and Labor and Delivery Research.