Job Details

Attorney in Boston, MA

Organization Type

Public Interest

Job Type

Non-practicing Attorney

Date Last Verified

Apr 13, 2021

Posted on

Sep 07, 2020

Years of Experience

3-5 yrs required

Location

Boston, MA, United States
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Senior Manager, Conflicts of Interest
Duties: Provides leadership and guidance in all efforts regarding the Conflict of Interest Program. Manages overall development and execution of a Health System-wide strategy related to individual and institutional conflicts of interest and conflicts of commitment. Develops a Health System-wide conflict of interest compliance strategy to mitigate risk and recommends best practices regarding foreign influence in research activity Serves as subject matter expert on conflicts of interest regulations and guidance and on the policies and procedures for the Hospital and its academic affiliate, University School of Medicine. Serves as resident expert on laws, regulations, policies and other questions regarding interactions with industry, foreign collaborators, consulting agreements, gifts, vendor relationships and Foreign Corrupt Practices Act. Achieves compliance objectives by working closely and collaborating with a variety of departments, including, but not limited to, Research Operations, Clinical Trials Business Office, Technology and Innovation, Development, Institutional Review Board, Office of General Counsel, Research, Billing and Privacy Compliance. Serves as liaison with Boston University Medical School on management of conflicts and related issues. Manages and coordinates the annual and ongoing conflict of interest reporting processes, including data collection for the IRS Form 990, and follows up with disclosers, as needed. Completes initial review, analysis and summary of data and documentation for conflict of interest submissions, including collection and review of related supplemental documents describing intellectual property and licensing agreements, human subject protocols, study-specific documentation. Coordinates with various stakeholders, including the Institutional Review Board, Office of Technology Development, Grants and Contracts Office, Clinical Trials Office, University Research Compliance Office, Covered Persons, and other departments and executives to compile relevant information to manage disclosures and to make recommendations for conflict management to the Faculty Committee. Supports both the Conflict of Interest Committee and the Faculty Committee in preparing agendas for meetings and materials for cases with Research Compliance Office Conflict of Interest Unit. Attends Faculty Committee meetings, presents cases and recommendations. Manages the online conflict of interest reporting system and coordinates with IT, Research Operations and others regarding system updates and reporting, and regularly tracks the conflict of interest online system, including review and disposition of open issues. Develops, provides and coordinates training and education regarding conflict of interest issues and applicable federal and state laws such as the Public Health Service regulations and the Physician Payments Sunshine Act, and administers training programs for Public Health Service-funded investigators. Manages and coordinates responses to inquiries and activities relating to conflict of interest disclosure and management and develops and maintains conflict of interest -related policies, procedures, and guidelines, including ongoing compliance monitoring. Ensures appropriate federal reporting of conflicts of interests, tracks compliance with management plans, oversees review of and response to information compiled by CMS under the Physician Payments Sunshine Act. Maintains and updates lists of investigators, employees and medical staff subject to disclosure requirements under conflict of interest policies as necessary to facilitate disclosure processes. Supports Chief Compliance Officer, Research Compliance Officer, and Director of Hospital Compliance with performance of other duties as requested. Provides leadership in managing daily assignments and tasks as they relate to assigned Boston University Law School intern.

Qualification and Experience

Qualifications: Bachelor’s degree in health policy, research administration, business administration or related field, graduate degree in law or health or research administration preferred; preferably in an academic medical center setting. Master’s Degree preferred. 3-5 years of experience in healthcare compliance, research compliance or research administration, with regulatory compliance experience. Familiarity with Public Health Service regulations and experience in management of research conflict of interest program.

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