Clinical Research Coordinator
CurrentCoordinator for multiple studies concerning rare genetic diseases. Responsibilities include but are not limited to conducting the informed consent process, screening subjects using protocol-specific inclusion/exclusion criteria, dispensing IDP and maintaining study drug use accountability, processing and shipping lab specimens, ensuring all data is collected as per protocol and transferred to EDCs, coordinating with home care nursing companies, submitting regulatory and ethical information to IRBs, maintaining regulatory study files, serving as point of contact for CRAs, participating in SIVs, COVs, and all interim monitoring visits, preparing and submitting quarterly invoices, scheduling subject visits and assessments both on- and off-site, monitoring and documenting patients’ adverse events, coordinating travel/hotel arrangements as well as stipend and reimbursement payments for subjects, creating source documents, writing and editing manuscripts for publication.