Senior Contract Specialist, Clinical Research Operations

Key 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, as necessary for evaluation, input, and guidance.
• 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. 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.

Minimum Qualifications
Education:

• Bachelor's degree

Experience:

• 2+ years of relevant experience.
• Identifies and resolves highly complex ethical, and/or operating problems, which require innovative solutions.
• 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.
• Ability to communicate effectively both verbally and in writing.