Sr. Contract Specialist Clinical Research Agreement - Boston, United States - Children's Hospital Boston

Description

75022BR

Job Posting Title:
Sr.


Contract Specialist Clinical Research AgreementDepartment:
Research- Clinical Trials OfficeAutoReqId:75022BRStatus:Full-TimeStandard Hours per Week:40

Job Posting Category:
Research

Job Posting Description:

General SummaryManages 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 experienceBoston Children's Hospital offers a competitive and inclusive benefits package

Office/Site Location:

BostonRegular, Temporary, Per Diem:
Regular Remote Eligibility :Part Remote/Hybrid