Clinical Research Associate 2

Job Summary: Position is Project Manager for a large multi-site clinical trial. Train and oversee CRA's on the project. Clinical Site is also Coordination Center for the clinical trial. Manage all aspects of the clinical trial at the Sponsor Level including but not limited to: Procuring study drug, site selection and management, vendor selection, consent form development, study document creation, study and data monitoring oversight, SAE and protocol deviation reporting and management, communication and periodic reporting to regulatory agencies and financial sponsors, secure and track all regulatory and financial documents from all sites; critical role in maintaining separation as Site and Coordination Center Candidate must have ability and desire to schedule meetings, write documents, review documents, design CRFs, answer site questions, identify and work with vendors (drug supply, labs, central pharmacy), work with IRBs, consult with biostatisticians, develop study manuals for sites, ...