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At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we’re committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included. The Clinical Research Agreements team manages the contract negotiation of industry-sponsored clinical trial agreements, industry funded investigator-initiated clinical trial agreements, any other type of industry funded clinical research agreements, and data use agreements, regardless of the source of funding. The Clinical Research Agreements team also works closely with the Office of the General Counsel, Compliance and other groups within Boston Children’s to make sure that clinical research agreements are compliant with BCH policies. Requires 1-2 times onsite a quarter. Must be permanently located or willing to relocate to New England to be considered.
Job Responsibility:
Drafts and negotiates written clinical research related agreements with corporate sponsors and other outside entities
Conducts negotiation of complex clinical research agreements and attends to relevant terms
Assures timely completion of negotiation proceedings
Acquires and maintains knowledge of Hospital’s policies and procedures applicable to clinical sponsored research and, applicable Harvard faculty policies and, other academic and professional standards for the conduct and administration of clinical sponsored research
Acquires understanding of corporate sponsor interests and of the regulatory environment and requirements for the research and development of products for market approval
Develops functional understanding of the business needs of the hospital administrative and research staff for the effective conduct and administration of clinical corporate sponsored research arrangements
Evaluates and makes recommendations for systems, policies and procedures to promote effective interaction between the hospital and industry for mutual benefit
Identifies, prioritizes and implements policy, programmatic and administrative procedural changes to enhance operational efficiency and effectiveness
Advises faculty on BCH and sponsor requirements for clinical corporate sponsored research agreements
Reviews all agreements and payment terms within budgets to ensure conformance with Hospital policies
Streamlines and standardizes all aspects of establishing and administering clinical corporate sponsored research agreements
Responsible for overseeing pre award administration of clinical research agreements to protect broad hospital interests, while serving faculty and corporate sponsor needs
Drafts and maintains templates for clinical research related agreements
Monitors arrangements to completion negotiating amendments and modifications as necessary, and coordinating closeout requirements
Supports strategies for marketing the hospital’s research capabilities and clinical trial resources to industry
Identifies and evaluates potential industry sponsors, and provides professional expertise to assist faculty members and research groups in obtaining commercial support
Advises on quality improvement efforts by providing appropriate feedback to “front end” e.g., principal investigators and study coordinators and other departments relative to issues that impact clinical research patient care
Conducts ancillary review of all protocols submitted to the IRB
Represents and promotes hospital’s interests in development of collaborative technology and programs with other non profit organizations
Participates in professional organizations and related forums to acquire and share current information, trends and practices.
Requirements:
Bachelor’s degree
2+ years of relevant experience
Identifies and resolves highly complex ethical, and/or operating problems
Ability to effectively negotiate with peer level department heads and/or with external agencies/facilities on issues and programs that impact department as well as several other large departments/divisions.
What we offer:
flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement