Administrative Core

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ABSTRACT The Administrative Core will provide managerial support for an enterprise capable of conducting syphilis research on the scale required to produce a vaccine with global efficacy. Such an enterprise requires 1) a broad base of epidemiologic, public health, clinical, translational, and basic research expertise among its investigators; 2) a combination of world-class research infrastructures; 3) clinical sites representing diverse STI populations, each with experienced, committed administrative/support personnel, deep local ties to patient populations, on-site capacity to process specimens, and experience securely transmitting specimens and data to collaborating institutions; and 4) a wealth of administrative experience to connect clinical sites with research institutions in the United States. The proposed Administrative Core builds upon collaborative research and administrative networks that are already well-established. All three principal participating institutions have deep academic and administrative ties to one or more of the foreign institutions or international consortia that directly administer or serve as partners in the management of our clinical sites. These institutions also provide the leadership and scientific and administrative skills that make the project possible. Both project leaders are internationally recognized research scientists with extensive experience with international collaboration and interdisciplinary research. The Project Directors bring deep knowledge of a rich variety of scientific fields. A team of seasoned administrators from the principal institutions will pool diverse backgrounds, providing needed administrative skills and experience. Building on this foundation, the proposed Administrative Core will implement five core managerial functions as its Specific Aims: (i) Management and Oversight. The Steering Committee will outline milestones and timelines and track progress. The Core managerial team will provide Project and Core Leaders with all needed administrative assistance, coordinate and promote communication within the CRC, provide financial management, and ensure compliance with all university and government regulations. (ii) Data Management. The Core data management team will establish a central REDCap Syphilis Database that will allow seamless, secure, HIPAA-compliant sharing of human- related data. (iii) Statistical Support. Experienced biostatisticians will provide statistical support for experimental design and data analysis. (iv) Training, career development, and mentorship. The CRC's Development and Research Program will foster scientific creativity, laboratory competence, and intellectual independence, and create mentorship opportunities. (v) Syphilis community outreach. Drawing on their extensive experience with local community organizations, each site will conduct syphilis community outreach activities that will enhance patient enrollment and establish strong community relationships, laying the foundation for a subsequent multi-site syphilis vaccine trial.