Massachusetts Jobs

Description:

• Under the general direction of the Associate Director of Contracting in the Clinical Trials Office (CTO), the Senior Contracting Specialist works with investigators, clinical trial coordinators, foundation and Industry sponsors and contract research organizations to negotiate clinical research agreements in accordance with BIDMC' institutional policies. The Senior Contracting Specialist provides orientation, training and mentoring to CTO clinical research agreement associates, conducts and coordinates peer-review and quality assurance activities within CTO and facilitates interactions with CTO and the Technology Ventures Office (TVO) and the Office of Sponsored Programs (OSP) regarding issues and agreements that overlap with CTO expertise. Represents BIDMC to foundation and industry sponsors and is primarily responsible for reviewing and negotiating Clinical Trial Agreements, Foundation Grants for clinical research, Clinical Research Support Agreements, Confidential Disclosure Agreements, Amendments, Subcontracts, Master Agreements and other Non-Funded Industry Agreements related to human subject research studies. Assesses each agreement for compliance with institutional 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 the Associate Director of the Clinical Trials Office, BIDMC 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.

Additional Skills & Qualifications:

Primarily responsible for drafting, revising and negotiating Industry-Sponsored Clinical Research Agreements, Foundation Grants for clinical research, Amendments, Subcontracts, Confidentiality Agreements, Service Agreements, and Master Agreements on behalf of BIDMC for human subject research. (essential)

Determines whether CTO and sponsoring entity have negotiated a standard clinical trial agreement and whether it is applicable to the proposed clinical trial (essential)

Prepares agreements for submission to sponsor using standard CTO format for clinical research

agreements. Negotiates with sponsor as necessary following established guidelines with particular regard to provisions regarding publication rights, confidentiality, intellectual property rights, HIPAA, AAHRPP, indemnification and subject injury (essential)

Determines the appropriate intellectual property provisions to include in agreements, in light of existing institutional commitments and likelihood that an invention will be made in the proposed work. (essential)

MUST Live in NH, RI, CT, VT, ME or MA.

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Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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