Conflicts Specialist

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Conflicts Specialist

Duties: Fostering a culture of integrity, and supporting an environment where individuals ask questions and report real or potential compliance-related concerns. Other functions include compliance education, as well as auditing and monitoring of compliance with applicable laws, regulations, and policies. Under the direction of the Conflicts of Interest Manager performs functions related to programs, processes, and policies with a particular focus on conflicts of interest and policy development related to relationships between faculty, workforce, and outside entities. Apply policies and regulations to analyze conflicts of interest issues and ensure appropriate financial interests are managed appropriately and disclosed timely to support institutional compliance with applicable regulations and policies. Supports the Institution’s Annual and Study-specific Conflicts of Interest (CoI) and Conflicts of Commitment (CoC) disclosure process, to include conducting the initial review, analysis, and summary of disclosures received by the Conflicts Management Office (CMO) from WCM faculty, staff, students and external collaborators – as per departmental assignments. Present problematic/high-profile disclosures to the COI Manager and/or Conflicts Advisory Panel (CAP) leadership simultaneously. Collect and review of related supplemental documents describing intellectual property and/or licensing agreements, sponsored research agreements, human subjects protocols, study-specific forms, project data and approval forms, and/or consulting agreements, including coordination with research regulatory committees and researchers, as required. Regular tracking and monitoring of online Conflicts Management System (CMS), including daily review of assignments (i.e., open issues and submissions). Coordinate and support preparation for the monthly CAP meetings, including (but not limited to) preparing of the annual review calendar, meetings, minutes, materials, reports, agendas, identifying meeting location(s), the dissemination of calendar invitations to CAP members to ensure a quorum is achieved at scheduled meetings, and ordering refreshments for the meetings. Prepare formal PowerPoint presentations to introduce complex, high-profile conflicts of interest related disclosures to the CAP membership for their deliberation and review. Draft management plans and apply revisions to existing management plans based on CAP feedback. Provides regulatory, policy and procedure 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 general and research-specific conflicts of interest policies and procedures to institutional leaders, faculty, employees, physicians, researchers, and other affected individuals through the development of support strategies, educational materials, educational workshops, newsletters, memos, and other appropriate means. Assists in the continuing assessment of the efficacy and efficiency of University’s COI policies and procedures. Recommend and participate in the implementation of updates in accordance with regulatory changes and university and community best practices. Ensures institutional compliance with the Sunshine Act through reviews of CMS reported data and identification of potential gaps. 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). Reports conflicts to federal government agencies (i.e., NIH) and other extramural sponsor’s (as required) and manages the sponsor relationship for all project specific research staff and project related sub-sites who have disclosed conflicts. Performs reviews of all pre-publication media press releases and scholarly publications from faculty and associated research staff to ensure legal compliance of appropriate and accurate disclosures. Support investigation of alleged violations of institutional policies concerning business, research and clinical conflicts of interest, gifts, vendor activities, and policies for faculty outside activities.

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