Research Compliance Associate

Dana-Farber Cancer Institute•Brookline, MA

21h

About The Position

The Research Compliance Associate II supports the Institute’s robust institutional conflicts of interest in research and outside activities programs. Responsible for the review of institutional outside financial relationships and financial interests in research to ensure compliance with institutional policies and sponsor regulations for conflicts of interest. This work advances and preserves the integrity of the academic mission of the Institute by facilitating beneficial collaborations with industry that improve academic research while ensuring that these activities are conducted within the requirements of institutional policies. Frequently interacts with faculty, research scientists, and study teams to provide advice on the policies relating to institutional conflicts of interest (ICOI)_in research, identifies instances of ICOI, and performs risk analyses to determine referral to Conflict of Interest Committees. Participates in developing and disseminating policies and education to faculty and research staff. Works independently with general supervision. 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. Under guidance from the Program Manager, Institutional Conflict of Interest, participates in the identification and review of the institute financial interests that may pose conflicts of interest in research according to institutional conflict of interest policies. In concert with Program Manager, Institutional Conflict of Interest, provide information and support to the DFCI Institutional Conflict of Interest Committee, and its subcommittees. Identify cases, trends, and issues for Committee consideration. Develop and maintain project reporting, tracking, or provide benchmarking as requested. Under guidance from the Assistant Director, COI Program and/or Program Manager, Outside Activities, provide timely intake and review of financial disclosures and outside activity agreements from faculty and research scientists that may pose conflicts of interest with research under institutional policies and sponsor regulations. Provide information and support to the DFCI Faculty Conflict of Interest Committee. Identify cases, trends, and issues for Committee consideration. Answer questions from faculty, research staff, directors, administrators, other internal customers or external academic affiliates regarding conflict of interest policies and processes in formal and informal settings. Facilitate compliance with institutional policies by enabling these individuals to understand policy requirements. Under guidance from Sr. Contract Negotiator, participate in the compliance review of faculty and research staff outside activity agreements as requested. Monitor updates and changes in institutional and sponsor requirements and maintain a current and in-depth understanding of policies and regulations regarding research conflicts of interest. Participate in the design and delivery of training and website content relating to institutional conflict of interest in research and conflicts of interest and institute policies on outside activities. 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. Support other ORIC team members during peak times of activity and perform other duties as assigned. Comply with office practices that support the efficient operation and documentation of the research conflicts of interest program. Support the Office of Research Integrity and Compliance to conduct an annual research compliance risk assessment and develop work plan to address identified risks, including conducting audit and monitoring activities. Contribute to the development of policies, procedures, and guidelines in functional areas, based on cases and other priorities or initiatives as identified by supervisors.

Requirements

Exercises adaptability and flexibility in a shifting environment.
Regulatory experience and ability to spot issues
Proficient level experience with MS Word, Excel, PowerPoint
Strong written and verbal communication skills
Strong organizational skills
Strong 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
Demonstrated ability to provide professional and collegial guidance and support to customers in navigating the complexities of a regulatory environment
Ability 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
Bachelor’s degree required; preferably in a scientific or legal field.
2+ years of experience with conflicts of interest, research compliance, or comparable regulatory experience.
Demonstrated ability in utilizing independent judgment; should possess knowledge about conflict of interest regulations and practices and have the ability to identify issues and problem solve in a deadline driven environment.
Requires a working knowledge about conflict of interest regulations and practices.
Practices discretion and diplomacy.

Nice To Haves

Experience as a clinical research coordinator with knowledge of FDA regulations.
Experience in an academic, research, or hospital setting (such as clinical trial management, research administration, clinical research compliance).
Background in science or medicine is a plus.
Demonstrated ability to pay close attention to detail and maintain auditable records.
Demonstrated ability to adapt to shifting deadlines and responsibilities.

Responsibilities

Participates in the identification and review of the institute financial interests that may pose conflicts of interest in research according to institutional conflict of interest policies.
Provide information and support to the DFCI Institutional Conflict of Interest Committee, and its subcommittees. Identify cases, trends, and issues for Committee consideration.
Develop and maintain project reporting, tracking, or provide benchmarking as requested.
Provide timely intake and review of financial disclosures and outside activity agreements from faculty and research scientists that may pose conflicts of interest with research under institutional policies and sponsor regulations.
Provide information and support to the DFCI Faculty Conflict of Interest Committee. Identify cases, trends, and issues for Committee consideration.
Answer questions from faculty, research staff, directors, administrators, other internal customers or external academic affiliates regarding conflict of interest policies and processes in formal and informal settings. Facilitate compliance with institutional policies by enabling these individuals to understand policy requirements.
Participate in the compliance review of faculty and research staff outside activity agreements as requested.
Monitor updates and changes in institutional and sponsor requirements and maintain a current and in-depth understanding of policies and regulations regarding research conflicts of interest.
Participate in the design and delivery of training and website content relating to institutional conflict of interest in research and conflicts of interest and institute policies on outside activities.
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.
Support other ORIC team members during peak times of activity and perform other duties as assigned.
Comply with office practices that support the efficient operation and documentation of the research conflicts of interest program.
Support the Office of Research Integrity and Compliance to conduct an annual research compliance risk assessment and develop work plan to address identified risks, including conducting audit and monitoring activities.
Contribute to the development of policies, procedures, and guidelines in functional areas, based on cases and other priorities or initiatives as identified by supervisors.