Sr Clinical Research Contracts Associate
- Location: Boston, MA
- Posted: Nov 13, 2019
Reporting directly to the Director, Clinical Research Agreements Office (CRAO) with dotted line responsibilities to the Belfer Office of Dana-Farber Innovations (BODFI), this unique position works closely with research investigators, BODFI Case Managers, department administrators and research teams of Dana-Farber Cancer Institute (DFCI) and other, academic institutions, not-for-profit corporations and industry pharmaceutical an d biotech companies to negotiate and execute research contracts for to support clinical research proposals at DFCI. Responsibilities are the negotiation of clinical/human subject research correlative and clinical trial agreements for a variety of clinical proposals involving human subjects in various stages of translational research. In consultation with Director, CRAO, Office of General Counsel (OGC) and BODFI liaison provides expert advice and legal support to the DFCI clinical research Investigators, program coordinators, as well as clinical trial infrastructure departments on various translational and correlative research agreement issues. Works closely with BODFI liaison and department Grants Managers on these in-between agreements that demand a high level of expertise to negotiate and a high degree of skill to work with the other departments to collaborate on. Works closely with research scientists and investigators to develop agreements based on correlative science and non-interventional protocols.
Working closely with clinical investigators, hospital and DFCI administration, and institutional and departmental business managers, has responsibility for negotiating various types of clinical research and clincial trial agreements for DFCI in timely manner and in conformance with DFCI contracting guidelines and standards. Specifically:Identifying DFCI studies that are to be externally sponsored.
Proactively contacting the PI and identifying self as the negotiator for the study.
Proactively contacting the third party supporting company or entity and arranging for draft contracts.
Arranging for concurrent budgeting of the clinical study with the appropriate financial individual(s) at DFCI and across DFHCC.
This process requires a complete understanding of:DFCI acceptable provisions for clincial research agreements
Relevant federal policy, regulations and guidelines surrounding translational research
Bayh-Dole Act (intellectual property provisions)
Conflict of interest regulations
Intellectual property and data rights of DFCI and third party and industry supporters
Develops positive working relationships with pharmaceutical and biotech companies. With Director, CRAO, attends meetings with industry and DFCI leadership to establish new research relationships. Helps build positive image of DFCI with industry representatives by helping to identify issues and barriers to relationship and works with Director CRAO on strategies for improvement.
Works proactively with the investigators to facilitate approaches to industry and make the negotiation process user friendly by:
Developing and conducting educational seminars for the clinical research community.
Monitoring timelines and identifying barriers to ensure contracts are executed in a timely fashion.
Identifying and resolving inter-institutional delays and barriers
Maintains positive and collegial relationship with Clinical Trials Budget Office, BODFI Finance personnel and Department Grants Managers. Assures coordination of contracting and budgeting activities for staff, and reviews OHRS submission documents and informed consent forms to ensure that these documents are in place that permit the research activity.
Develops and maintains positive working relationship with the BODFI Case Managers and Clinical Trials Agreements Associates.
Keeps abreast of clinical research legal issues and regulatory matters. Works closely with Director, CRAO to ensure DFCI compliance with changing guidelines.
Tracks the status of ongoing research agreement negotiation using the InfoEd database. Keeps Director, CRAO updated on changes in average timeframe and issues and concerns on specific contracts across the departments.
Coordinates the maintenance of files of executed research agreements.
Works closely with the Director CRAO, BODFI liaison and DFCI Office of General Counsel to resolve research contract legal issues.
This position has access to professional confidential information regarding intellectual property of the institution and industry sponsors as well as institutional financial information. All of the foregoing requires the utmost confidential treatment.
J.D. degree strongly preferred, bachelor's required, and five years or more of experience in research contract negotiation in a healthcare setting
Demonstrated ability to work independently with minimal supervision
Outstanding negotiation and conflict management skills
Strong collaboration skills
Strong organization and time management skills with ability to multi-task in a highly time sensitive environment
Strong leadership skills geared towards training and mentoring junior level professionals
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Prior legal research contract negotiation experience.
Strong leadership skills
Strong negotiation skills.
Advanced level experience with MS Word, Excel, PowerPoint
Excellent written and verbal communication skills, particularly email communication.
Strong organizational skills, including typing, editing and proofreading skills.
Ability to prioritize and complete tasks independently and in a timely manner.
Ability to make sound administrative judgments and assume responsibility for decisions.
Must be able to anticipate the needs of the individuals assigned to support.
Must be able to maintain information that is sensitive and frequently of a confidential nature.
Strong problem solving skills and the ability to work both independently and as a member of a team.
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 underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
- full time