Job Details

Research Compliance Manager

Company name

Brigham and Women's Hospital

Organization Type

Public Interest

Job Type

Attorney

Valid Through

Nov 27,2019

Posted on

Aug 14,2019

Years of Experience

Min 5 yrs required

Location

Boston, MA, United States

Employment Type

Full-time

Industry

Legal
Practice Area
Health Care >> Health Care
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Research Compliance Manager
The candidate will review, draft, and negotiate agreements related to research and academic activities within the Hospital including international agreements, data sharing and data use agreements, academic and research collaborations. Provide ongoing support for sponsored projects throughout their life cycle. Will work with other Hospital and Partners Healthcare groups to triage complex agreements and collaborations, provide assistance with regard to institutional policies and procedures as needed. Serve as a resource to firm's Departments and Divisions engaging in Sponsored Programs activities with respect to risk management, regulatory compliance, and administrative efficiency. Support a wide range of Research Compliance activities including, export and import controls, Investigator transfers, research staff matters, data use and sharing, privacy and confidentiality of research material, and research and data integrity. Provide comprehensive regulatory guidance to the firm's research community regarding the responsible conduct of research. Conduct targeted risk assessments and develop comprehensive corrective action plans or remedial measures to address identified areas of concern. Create monitoring and auditing programs to address areas identified by the risk assessments related to research compliance areas. Develop, implement, review and/or revise firm's-specific research policies and procedures as necessary to ensure that all regulatory requirements and institutional or Partners policies or practices are appropriately supported and upheld. Design and deliver focused training and education plans based on findings from firm's risk assessments and audits, regulatory changes and enforcement activities, and new policies and procedures. With the Director of Sponsored Programs and Compliance develop tools and systems for managing Sponsored Program activities. Assist in the development and posting of new content for internal and external firm's websites. In conjunction with the Director of firm's Sponsored Programs and Compliance, coordinate reports to regulatory oversight agencies and facilitate investigations and responses to requests for information from various government entities. Investigate reports related to noncompliance at firm's. Identify and develop corrective action plans to address instances of noncompliance, as appropriate. Coordinate data collection, review and reporting as needed to support ongoing compliance investigations. Research periodicals, internet sites, and government publications to keep abreast of federal, state, and local developments and compliance efforts related to research. Develop communication tools to share this information effectively across the firm's research community. Perform other related duties and responsibilities as required.

Qualification and Experience

The candidate should have J.D. or graduate degree in a healthcare field; related healthcare or legal experience considered in substitution. Must have 5 years of related experience required, preferably in compliance role. Administrative/management experience strongly preferred. Thorough familiarity with current applicable laws and regulations, including federal, state, and non- federal regulations surrounding research and research grants is required. Must be proficient in using computer software applications such as Microsoft Excel, Word, PowerPoint, Visio and Adobe.

Additional info

ref 3100990

Company info

Hiring Coordinator
Brigham and Women's Hospital
75 Francis St.
Boston, MA 02115

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