Dana-Farber Cancer Institute is seeking a Research Compliance Officer (RCO). The Research Compliance Officer will be responsible for implementing and directing a high quality, robust and visible research compliance program for the Institute. The position will include responsibility for investigation and resolution of research compliance issues, providing regulatory guidance and advice on research compliance matters, and conducting or coordinating focused training and education on research compliance. The RCO will monitor various DFCI departmental operations as they relate to research compliance risk areas.
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. #LI-CP1
Receive, investigate, document and track research compliance concerns from workforce members, patients and/or family members, the compliance hotline or other sources. Develop and implement (or oversee implementation of) corrective action plans (including ensuring consistent application of disciplinary action standards) in response to such complaints and investigations.
Based on outcomes of research compliance investigations, report to state and federal authorities, as appropriate.
Develop, implement, maintain and oversee training and education program for research compliance issues for the Institute, including, for example, new employee orientation, annual online training and department-specific training.
Work with 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 modify the research compliance program accordingly to remain compliant, as well as consistent with industry best practices.
Enhance professional growth and development by participating in educational programs, distributing and reading current literature and conducting and participating in in-service meetings and workshops.
Serve as an Institute resource on the laws, regulations and internal policies pertaining to research compliance.
Work with and synchronize 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.
Work well, and coordinate, with counterparts at other Dana-Farber/Harvard Cancer Center (DF/HCC) sites, Harvard Medical School-affiliated institutions, and outside research sites.
Advise and/or participate in DF/HCC institutional review boards, institutional and individual conflict of interest (COI) committees.
Initiate, facilitate and promote activities to foster research compliance awareness within the Institute.
Prepare written documentation, reports, presentations, etc. as required by the profession and the department; maintain, distribute, analyze, and collect information for required records, reports and statistics, trends, etc. as directed.
Perform any other functions assigned to the RCO pursuant to policies and procedures regarding research compliance or by the CCO.
The RCO will be Compliance's representative for investigations of research misconduct led by the Office of Research Integrity.
Bachelor's degree required. Advanced degree (Masters, Juris Doctor, PhD) preferred.
4+ years of experience in research, research compliance and/or compliance.
Certified in Healthcare Research Compliance (CHRC) or Certified in Healthcare Compliance (CHC) a huge plus.
Strong commitment to research compliance and possess strong ethical compass.
Knowledge of and experience in working with federal and state research compliance laws, regulations and sub regulatory guidance.
Experience successfully leading and/or participating in cross-functional teams.
MS Office (Word, Excel, Access, Powerpoint) expertise and compliance issues management database.
Flexibility during off hours required for emergency situations.
Commitment & ability to:
Work in a team-based environment
Handle patient and highly reputable researcher interactions/communication with extreme care, patience and consideration, and create an environment with open channels of communication within the Institute with workforce members, patients and others.
Possess excellent organization, attention to detail, technical and analytical skills. Can gather relevant information systematically, break down problems into simple components and can make sound decisions.
Approach problems with curiosity and open-mindedness and offer new ideas, solutions and/or options. Demonstrate discretion, diplomacy, and good judgment.
Possess strong communication and presentation skills; clearly and concisely express ideas in groups and one-to-one conversations, formal and informal documents. 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 and change management skills; ensuring projects come to fruition from inception to completion.
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.
Internal Number: 2020-19374
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.