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.
Reporting to the Director, Clinical Research Agreements Office (CRAO), the Clinical Research Contracts Associate works with investigators, clinical trials coordinators, senior administrators and representatives of Dana-Farber Cancer Institute and Dana-Farber/Partners Cancer Care (DFPCC) affiliated hospitals Brigham and Women's Hospital and Massachusetts General Hospital, Dana Farber/Harvard Cancer Center (DF/HCC) institutions, other hospitals, academic institutions, and other not-for-profit corporations, as well as industrial sponsors and contract research organizations. Oversees the negotiation of clinical research related legal documents, such as clinical trial agreements, inter-institutional agreements, and IRB reliance agreements. In consultation with Director, CRAO and Office of General Counsel (OGC) provides expert advice and legal support to the DFCI and DF/HCC clinical research Investigators, program coordinators, as well as clinical trial infrastructure departments across DF/HCC on clinical trial agreement issues.
- Working with clinical investigators, hospital and DF/HCC administration, and institutional and departmental business managers, has responsibility for negotiating clinical trial agreements and associated research agreements for DFCI, DF/PCC, and DF/HCC in timely manner and in conformance with DFCI and Partners standards.
- Develops positive working relationships with pharmaceutical companies. Helps to build positive image of DF/HCC, DF/PCC and DFCI with representatives by helping to identify issues and barriers to relationship and work 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.
- Following progression of protocol reviews to assure contracts are executed in a timely fashion.
- Identifies and resolves inter-institutional delays and barriers
- Maintains positive and collegial relationship with Clinical Trials Budget Office. Assures coordination of contracting and budgeting activities, and reviews informed consent forms to assure that these documents are consistent.
- Develops and maintains positive working relationship with the clinical trials contractors at DF/HCC institutions. Meets regularly with these individuals to maintain excellent communications and minimize problems in contracting. Keeps Director, CRAO informed of issues, as they arise.
- Participates in meetings with representatives of the DF/HCC and of Partners Clinical Trials Office to discuss uniform procedures and standards to apply agreements that apply to all the relevant affiliated institutions.
- Builds positive trusting working relationship with Agreement Associates at BIDMC, CHB and Partners.
- Work directly with SVP-R at DFCI, MGH and BWH on contract issues that require SVP-R approval.
- Ensures compliance with policies and procedures related to Partners clinical trials agreements.
- Monitors issues and present summaries of any potential or actual problems or conflicts to Director, CRAO and SVP-R DFCI, MGH and BWH with the goal of resolving issues in a timely manner and permitting clinical trials to be performed at DF/HCC institutions.
- Keeps abreast of clinical research legal issues and regulatory matters. Works closely with Director, CRAO to ensure DFHCC compliance with changing guidelines.
- Assures timely contracting of clinical trials agreements by department. Track the status of each ongoing clinical trial negotiation using the InfoEd database. Keeps Director, CRAO updated on changes in average timeframe and issues and concerns on specific contracts.
- Maintains files of executed clinical trial agreements for the DF/PCC.
- Works closely with the Director CRAO and DFCI Office of General Counsel to resolve research contract legal issues across DF/HCC institutions.
- Participates in the Clinical Trials Business Office Clinical Trial Allocation Committee meetings to discuss DF/PCC allocations and other issues that may arise in the preparation and allocations of DF/PCC studies.