The work location for this position is full remote, however the selected candidate must live and work from one of the New England states (ME, NH, VT, MA, RI, CT)
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Reporting to the Vice President for Research Integrity and Senior Vice President for Research, the Research Compliance Officer (RCO) will be responsible for implementing and sustaining a comprehensive research compliance program for the Institute.??The position is responsible for overseeing the investigation and resolution of research compliance issues, developing research compliance policies and procedures, providing regulatory guidance and advice on research compliance matters to faculty and staff at all levels of the Institute, overseeing training and education on research compliance, and leading the newly created Research Compliance Committee.??
The RCO will oversee a program that promotes integrity and compliance throughout all facets of the Institute???s complex research and sponsored programs.?? To this end, this role will have full free and unrestricted access to all functions, records, property, and personnel under review.??The RCO will monitor various DFCI departmental operations as they relate to research compliance risk areas.??
Supervise the Research Compliance Team within the Office of Research Integrity and Compliance to receive, investigate, document and track research compliance complaints from workforce members, patients and/or family members.??Develop and implement consistent application of responsive or disciplinary action standards to address such complaints and investigations.
Plan, assign, review work, and manage performance of the Research Compliance Team.??Assist the VPRIC in activities related to the management of the Research Compliance Team.
Coordinate with the Research Compliance Team and other stakeholders to report to state and federal authorities (including, for instance, research sponsors such as the NIH, and the FDA, the Office for Human Research Protections (OHRP) and/or the Office for Laboratory Animal Welfare (OLAW), as is required.
Assist the Research Integrity Officer and other team members with research misconduct investigations.
Develop and oversee adequate educational program and resources for research compliance issues affecting the Institute, including, for example, through conducting new employee orientation, annual online training, and department-specific training on research regulatory issues.
Work with Research Communications and other departments, as necessary, spearheading efforts to effectively communicate research compliance messaging and education.
Conduct annual research compliance risk assessment and develop work plan to address identified risks, including conducting audit and monitoring activities.
Cooperate with federal and state entities in any research compliance program audits, inquiries or investigations.
Develop, implement, maintain, and oversee research compliance policies and procedures of the Institute.
Stay current with relevant federal and state research compliance laws and regulations, and update DFCI???s research compliance program accordingly to remain compliant and consistent with industry best practices.
Continue professional development by participating in educational programs, distributing updates to stakeholders, and conducting meetings and workshops on relevant regulatory issues and updates affecting the DFCI research community.
Serve as an Institute resource on the laws, regulations and internal policies pertaining to research.
Work with a variety of Institute departments and offices (e.g., faculty activities, research administration, grants and contracts, clinical trials, human and animal subject protection, privacy, technology transfer, etc.) on achieving research compliance objectives.
Coordinate with counterparts at other Dana-Farber/Harvard Cancer Center (DF/HCC) sites, Harvard Medical School-affiliated institutions, and outside research sites.
Prepare written documentation, reports, presentations, etc. as required; maintain, distribute, analyze, and collect information for required records, reports and statistics, trends, etc.
Perform other functions as needed.
Bachelor???s degree and advanced degree required (e.g., Juris Doctor, Masters, Medical Director or PhD), or equivalent experience.??
10 years of experience in healthcare and regulatory research compliance and academic medical center experience required.??
Direct experience in research compliance required.
Certified in Healthcare Research Compliance (CHRC) or Certified in Healthcare Compliance (CHC) preferred.
Strong commitment to regulatory compliance ethics.
Extensive current knowledge of federal and state research compliance laws, regulations and guidance.
Work well on a team,
Communication with discretion, patience and consideration, and
Foster an environment of the highest ethical conduct, as garnered through open communication, candor, and uniform application of standards and sanctions, within the Institute.
Possess excellent organization, attention to detail, and analytical skills.??
Possess strong communication and presentation skills.?? Adapt writing and communications styles to fit the audience.
Initiate, develop, and maintain relationships and networks with peer research compliance officers, research compliance groups and committees (e.g., Partners HealthCare System and Alliance of Dedicated Cancer Center Research Compliance Officers and related groups).
Project management skills and ability to prioritize effectively; ensuring projects come to fruition from inception to completion.
MS Office (Word, Excel, PowerPoint) expertise.
Directly manages Associate Director and Managers.
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.??
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.?? As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.?? Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
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.