Manages business aspects of clinical corporate-sponsored research, under the direction of the Clinical Research Agreement group within the Clinical Research Operations leadership. Advises Hospital officials on trends and policies affecting clinical corporate-sponsored research. Negotiates clinical research-related agreements and is responsible for maintaining the internal contract database.

Responsibilities

• 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.
• Consults with other Hospital staff in Legal Office and Compliance.
• Acquires and maintains knowledge of Hospital's policies and procedures applicable to clinical sponsored research 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.
• 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.
• Develops goals and objectives in accordance with hospital and departmental goals, mission, and values. Plans and develops implementation strategies.
• Monitors and maintains program compliance with legal and regulatory requirements.
• 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.
• Identifies and resolves highly complex ethical, and/or operating problems, which require innovative solutions, based cross functional knowledge of the healthcare industry.

Skills

• .Ability to effectively negotiate with peer level department heads and/or with external agencies/facilities on issues and programs that impact assigned department as well as several other large departments/divisions.
• Ability to communicate effectively both verbally and in writing.

Requirements:

• Bachelors Degree (Life Science or closely related field)
• 2 years of relatable experience

Boston Children's Hospital offers a competitive and inclusive benefits package.