Reporting to Director, Clinical Research Agreements Office (CRAO) , works and consults with investigators, research team staff, department administrators, senior research leadership, members of Belfer Office of Dana-Farber Innovations (BODFI), CRAO, Grants and Contracts (G&C), Dana-Farber Office of General Counsel (OCG) and key representatives across Dana-Farber Cancer Institute (DFCI) Â and Dana Farber/Harvard Cancer Center (DF/HCC) institutions, as well as external academic institutions and other not-for-profit corporations beyond DF/HCC, industry sponsors, research supporters and collaborators and contractors Â to intake, manage, negotiate and process research related legal documents research support agreements and research related services at DFCI. These agreements may involve one or more than one funding source (i.e. industry support, grant support, philanthropic dollars or in-kind support), and requires coordination through a single point of contact to develop and negotiate such agreements but liaise with the appropriate central research offices and departments to ensure proper execution of the agreements.Â Â A large component of this this role also is to serve as the key point of contact and research agreement support for the Cell Manipulation Core Facility (CMCF) agreements, which are highly legally and technically complex agreements that involve clinical trials, manufacturing and industry research agreements.Â
Working with clinical investigators, DFCI and DF/HCC administration, and institutional and departmental business managers, has responsibility for negotiating research agreements and associated research support agreements for DFCI in timely manner and in conformance with DFCI standards of practice and relevant legal requirements and obligation.
Â Support DFCI Grants & Contracts Office to assist with drafting, review, and negotiation of grant funded research agreements, subcontracts, and/or grant funded clinical trial agreements from industry, non-profit or state or governmental agencies, research Consortium agreements from academic institutions, public and private foundations, and for-profit organizations ensuring compliance with institutional policy and applicable laws.
Develops positive working relationships with pharmaceutical companies. Helps to build positive image of DFCI and DF/HCC with key institution and industry representatives by helping to identify issues and barriers to relationship and works closely with Directors of CRAO, BODFI, G&C and DFCI senior administration and scientific leadership on strategies for improvement.
Works proactively with the investigators to facilitate approaches with sponsors and external industry supporting entities to make the negotiation process user friendly by:
Serving as the responsible party and point of contact to negotiate agreements while reaching out to all key offices to ensure that they are consulted on these agreement
Identifying and resolving inter-institutional delays and barriers.
Maintains positive and collegial relationship with all collaborative offices. Assures coordination of contracting and budgeting activities for each agreement and, as necessary, reviews informed consent forms to assure that these documents are consistent. Effectively works with departments and division administrators, investigators and finance to facilitate the resolution of identified budgetary problems, overseeing and assuring that resolutions are in compliance with applicable laws, DFCI guidelines and industry standards.
Participates in meetings with representatives of the DFCI research offices to discuss uniform procedures and standards to apply agreements that apply to DFCI and all relevant affiliated institutions.
Builds positive trusting working relationship with CRO Agreement Associates, BODFI staff and G&C staff.
Work directly with SVP-R at DFCI, and Chief Scientific Officers of Research and Clinical Research and Deputy Chief Scientific Officer Clinical Research on contract issues that require Sr. Leadership review and approval.
Ensures compliance with policies and procedures related to clinical research agreements.
Monitors issues and present summaries of any potential or actual problems or conflicts to Director CRAO and SVP-R DFCI with the goal of resolving issues in a timely manner and permitting clinical trials to be performed at DFCI and DFCI affiliated institutions.
Keeps abreast of clinical research legal issues, federal grants requirements and regulatory matters.
Assures timely contracting of research agreements by department. Track the status of each ongoing negotiation. Keeps Director CRAO updated on changes in average timeframe and issues and concerns on specific contracts.
Maintains electronic files of executed research agreements.
Works closely with the key DFCI research office Directors and DFCI Office of General Counsel to resolve research contract legal issues.
MINIMUM JOB QUALIFICATIONS:
J.D. degree and five years or more of experience in healthcare setting
Quick learner; demonstrated ability to learn independently
Business management and clinical background a strong plus
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
This position has access to professional staff salaries, patient information, and industry and external sources funded agreements. All of the above requires the utmost confidential treatment.
Must have demonstrated ability to work independently with minimal supervision as well as possess outstanding negotiation and conflict management skills.Â
Strong organization and time management skills with ability to multi-task in a highly time sensitive environment
Experience as an effective team leader, including strong verbal and written communication, presentation, collaboration and consensus-building skills.
Ability to tactfully and effectively respond to and handle a broad range of organizational, operational, and project management situations, challenges, and constraints.
Demonstrable problem-solving skills and ability to work independently.
Ability to effectively interact with Departments at DFCI and representatives from DF/HCC and external institutions
Must be able to integrate input and interface with multiple stakeholders within the DFCI Research Community.
Strong interpersonal and communication skills with a focus on customer service. The ability to be flexible and highly organized is essential.
Excellent analytical and problem-solving skills.
Internal Number: 2021-21665
About Dana-Farber Cancer Institute
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.