Senior Contracting Specialist

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Senior Contracting Specialist

Duties: Supports the organization's mission to provide patients with opportunities to participate in the most current research protocols, and faculty members the ability to properly implement studies and publish research data related to protocols. Represents to industry sponsors and is primarily responsible for reviewing and negotiating Clinical Trial Agreements, Clinical Research Support Agreements, Confidential Disclosure Agreements, Amendments, Subcontracts, and other Non-Funded Industry Agreements related to human subject research studies. Assesses each agreement for compliance with institutional and Harvard policy, and applicable Federal and State Laws, in the areas of indemnification, subject injury, HIPAA, confidentiality, publication, funding terms, intellectual property rights, insurance, termination, arbitration, and AAHRPP requirements. Works closely with Clinical Trials Office Contracts Manager, General Counsel, members of the Office of Business Conduct and others to accomplish these responsibilities. Maintains institutional database regarding contracts and contractual issues and works with clinical trials financial analysts as needed to complete the work of the CTO. Reviews, negotiates and prepares for execution the agreements with industry sponsors for studies related to human subject research. Assesses each agreement for compliance with policy and Federal/ State Laws, in areas of indemnification, subject injury, HIPAA, confidentiality, publication, funding terms, intellectual property rights, insurance, termination, arbitration, and AAHRPP requirements. Reviews, negotiates and prepares for execution sub-contract agreements related to industry supported human subject research with other institutions for studies being conducted and sub-contract agreements received from other institutions. Reviews, negotiates and prepares for execution, Confidential Disclosure Agreements with industry sponsors for human subject research studies. Assesses each agreement for compliance with institutional and policy and applicable Laws pertaining to confidentiality. Reviews, negotiates and prepares for execution all amendments for agreements with industry sponsors for studies related to human subject research. Compares and assesses the language in the requested amendment with the original contract for accuracy and whether any revisions to the agreement are necessary and applicable. Reviews, negotiates and prepares for execution any industry gifts or awards of grants-in-aid and other educational projects in support of specific human subject protocols in accordance with the medical center's mission.

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