Clinical Trials Agreements Associate

Facilitates interactions with CTOs, research management (RM) and innovation groups regarding issues and agreements that overlap with CTO expertise. If all of the above criteria are met, the university may grant the proponent a number of rights to inventions made during the direct implementation of the clinical trial protocol. The terms in the model clinical trial agreement are used for Phase III or IV studies that meet the above criteria and involve little or no involvement of the investigator in the design or development of the protocol. However, the university verifies the terms of the patent on a case-by-case basis, preferring to do so with a thorough understanding of the work being considered. In addition, all agreements entered into by the university are subject to disclosure under the California State Public Registration Act. As a government-subsidized institution, the UCI must recover all research costs from external sponsors, including all overhead operating costs. In other words, for-profit research would be subsidized by public funds. Overheads are facilities and administrative costs (R-D) to support the university`s research infrastructure. The university aggregates its overheads for simple accounting, as it is difficult to attribute these costs to a specific project or program with a relative degree of accuracy. The Federal Office of Management and Budget sets the standards for calculating the indirect rate of costs and the UCI regularly negotiates its rates with the audit agency of the U.S. Department of Health and Human Services. The university deducts its overhead rate for clinical trials from the applicable components of the federally approved rate. Prepares agreements for submission to sponsors using the standard CTO format for clinical research agreements.

negotiates with the promoter, if necessary, in accordance with established guidelines, including provisions relating to publication rights, confidentiality, intellectual property rights, HIPAA, compensation and infringement of the object. Although each document is reviewed on a case-by-case basis, there are a number of key issues that are common to most clinical trial agreements. These points are negotiated by SP with the sponsor: determines whether the CTOs and the sponsoring companies have negotiated a standard clinical trial agreement and whether it applies to the proposed clinical trial. First, he is responsible for negotiating and implementing clinical research agreements for MGH and BWH. Negotiate sponsored clinical research agreements, confidentiality agreements, service agreements and equipment transfer agreements. Responsible for negotiating research and education partners programs (PREP) clinical research agreements, as requested by the Community Partner Organization. The Clinical Research Agreement Associate I works under the close control of the Director, Corporate Sponsored Clinical Research Contracting and under the General Direction of the Corporate Director of the Office of Clinical Trials (CTO) within the PHS Office of the Chief Academic Officer.