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Beth Israel Deaconess Medical Center Senior Contracting Specialist in Boston, Massachusetts

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Senior Contracting Specialist

Department Description:Research & Academic Affairs - CTO, Contracting

Job Location:Boston, MA

Req ID:35057BR

Job Summary: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 BIDMC 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, 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.

Essential Responsibilities:

  • 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 at BIDMC 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.

Required Qualifications:

  • Bachelor's degree required .

  • 1-3 years related work experience required.

  • Good oral and written communications skills as well as grammatical skills.

  • Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.

Preferred Qualifications:

  • Experience in contract negotiation, or paralegal experience preferred.

Competencies:

  • Written Communications:Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.

  • Oral Communications:Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.

  • Knowledge:Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.

  • Team Work:Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.

  • Customer Service:Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.

Physical Nature of the Job:

Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally

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