Sr. Contract Specialist Clinical Research Agreement
1 month ago
General Summary
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.
- .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.
- Bachelors Degree (Life Science or closely related field)
- 2 years of relatable experience
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