Research Compliance Associate

Weill Cornell Medicine is a comprehensive academic medical center that is committed to excellence in patient care, scientific discovery, and the education of future physicians and scientists in New York City and around the world. Our doctors and scientists - faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization - are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies.

Reporting to the Manager, Conflict of Interest (COI), the Research Compliance Associate executes Weill Cornell Medicine’s (WCM) federally compliant COI program for a substantial portfolio of academic and non-academic personnel. Contributes to the development and implementation of policies, procedures and guidance documents governing WCM, and its faculty, workforce, affiliates and external collaborators.

Job Responsibilities 

• Reviews and analyzes a high volume of conflict-of-interest (COI) survey disclosures received through WCM’s research enterprise platform. Ensures all COI Surveys within their assigned portfolio are current and active within the last 12 months.
• Addresses deficient and discrepant conflict surveys and drafts Standard and Complex Conflict Management Plans that address conflicts disclosed in conflict surveys.
• Presents draft plans to Conflicts Advisory Panel (CAP) chairs and incorporates revisions to existing management plans based on feedback.
• Monitors both the implementation of Management Plans and the adherence to terms and guidelines of those Management Plans in collaboration with the Dean's designee and/or the Conflicts Oversight Review Committee (CORC).
• Prepares documentation, preps CAP committee members and attends annual management plan review meetings for faculty on Complex Conflicts Management Plans. Ensures every plan in their portfolio is updated annually based on disclosures.
• Meets weekly with departmental leadership to present complex cases and address expired surveys.
• Prepares agendas, provides supporting documents and case details identified through communication with appropriate parties, identifying applicable guidelines and regulations, and exploring other related avenues of resolution for consideration.
• Documents and acts upon leadership directives received during meetings. Maintains comprehensive minutes in a centralized location for reference. Tracks and completes all action items associated with this process.
• Analyzes conflicts disclosures of Key Personnel against Internal Review Board protocols (e.g., initial submissions, amendments, etc.), as well as Institutional Animal Care and Use Committee, DSMB and other committee members of various boards, as required.
• Monitors and responds to general COI inquiries from WCM faculty, staff and students sent to the COI listerv. Serves as a central repository of information related to COI matters. Escalates sensitive and complex matters to COI Manager, as needed.
• Reviews and completes sponsored research project specific COI documents for the Office of Sponsored Research Administration (OSRA) and other central offices, as required.
• Reviews financial conflicts and conflicts of commitment for federal and non-federal agencies, including but not limited to, the National Institutes of Health, and submits Financial Conflict of Interest (FCOI) documents in sponsor platforms as mandated.
• Prepares all components of monthly Conflicts Advisory Panel committee meetings including slide-decks, supporting documentation, confirms adequate attendance to achieve quorum, schedules guest faculty attendance, and documents minutes for central storage.
• Uses available tools and features of the Conflicts Management System to track and manage workflow including daily review of assignments.
• Provides regulatory, policy, and procedural related advice and information to the CAP and Institutional Review Board (IRB) to inform their review and assessment of reported financial conflicts of interest.
• Assists with communication efforts governing conflicts of interest policies and procedures through the development of support strategies, educational materials, educational workshops, newsletters, memos, and other appropriate means.
• Collaborates with External Affairs to ensure that all public relations, including interviews, print/social media, press releases, promotional videos, and website maintenance comply with COI/COC policies.
• Assists in the continuing assessment of the efficacy and efficiency of COI policies and procedures. Recommends and participates in the implementation of updates in accordance with regulatory changes and university/community best practices.
• Provides support to the Research Integrity Officer (RIO). Serves as liaison between business units, including University Counsel and Cornell’s Center for Technology Licensing (CTL).
• Ensures institutional compliance with the Sunshine Act through reviews of CMS reported data and identification of potential gaps.
• Provides disclosure language for Informed Consent Forms (ICF), mixed-media releases, publications. Confirms accurate and complete representation of faculty disclosures in VIVO profiles.
• Completes additional research compliance work assignments. Readily implements new processes, workflows and policies in accordance with the changing needs of Weill Cornell Medicine, its faculty and its leadership.

Education 

• Bachelor's Degree.
• Master's Degree in related field preferred.

Experience

• Strong analytical skills. Ability to understand, apply and communicate complicated federal regulations and internal policies to individuals at all levels within the College while maintaining high level of confidentiality.
• Ability to work on matters of high sensitivity with diplomacy and discretion
• Ability to work independently and to make decisions on projects without additional oversight.
• Extensive understanding of regulations and laws related to financial interests in research, as well as corporate and industrial relationships that raise potential financial conflicts of interest and ethical considerations in conducting research.
• Demonstrated ability to achieve results in a fast paced, deadline driven environment with multiple priorities and multiple stakeholders.
• Ability to successfully collaborate with individuals and committee members to elicit needed information, discuss potentially sensitive information and develop workable solutions to meet the applicable policies and to protect the research enterprise.