Manage and oversee activity at network performance sites located throughout the United States during study start-up (assure proper supplies and regulatory submissions) and study conduct. Serve as the liaison between the clinical site(s) and the SIREN CCC to resolve any issues that may arise throughout the course of the study. Review, track and maintain regulatory documents and master trial files. Create program materials and provide study-specific staff at SIREN performance sites. Develop and revise study SOP’s, procedure manuals and study related items such as newlsetters as needed. Collaborate with SIREN study teams on the development of case report forms, data collection tools and data bases. Organize and conduct coordinator/investigator conference calls and participate in Network st