The Administrative Core will be responsible for the overall management of this IPCAVD program according to PAR-06-286. The Administrative Core will be responsible for interacting with the DAIDS Program Officer and Staff as required by the U19 funding mechanism as a multi-project cooperative agreement between our team and NIH. The Administrative Core will also perform its duty to coordinate all aspects of routine program management on administrative, financial, regulatory, and clinical issues. The Administrative Core will organize and interact with external advisors, and host annual external reviews.
Aim 1 : To coordinate the interactions a) among scientists from different institutions included in the current program, and b) between our team and NIH personnel regarding efficient implementation of proposed plans and projects.
Aim 2 : To oversee all budgetary matters, including review and approval of subcontract agreements negotiated through the Project Management Group (PMG) of Project 3, and the monitoring of monthly expenses and preparation of various reports.
Aim 3 : To maintain records of pre-IND and IND application documents with the US FDA and coordinate efforts in IND filing and clinical protocol reviews required by different agencies, institutions, and committees.
Aim 4 : To work with HVTN to improve, implement, and execute the Clinical Development Plan including the timely start of clinical testing at HVTN of our modified multi-gene, polyvalent HIV vaccine formulation to be developed by this application.
Aim 5 : Information management: to provide bioinformatics and statistical support, to develop an Intellectual Property plan, and plans to promote data standardization, data and resource sharing.
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