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Research Compliance QA/QI Specialist - Harvard Pilgrim Health Care Institute, Boston, Massachusetts
Exciting opportunity to work in a research environment dedicated to improving health care delivery and population health through innovative research and teaching.
Summary of Position
Under the direction of the Research Integrity & Compliance Officer, the Research Compliance Quality Assurance/Quality Improvement (QA/QI) Specialist is responsible for contributing to the success of the regulatory research compliance program by assisting with the development, oversight, and monitoring of the regulatory research compliance function at Harvard Pilgrim Health Care Institute which includes, but is not limited to: protection of human subjects; conflicts of interest management, export controls, the accreditation process, responsible conduct of research, training and education, responding to allegations of research noncompliance and remediation training.
The Research Integrity & Compliance Office within the Office of Sponsored Programs oversees the regulatory research compliance program. This includes the services of the institutional review board (IRB), as well as conflicts of interest management, research integrity and research auditing/monitoring, including accreditation.
Duties and Responsibilities:
Under the direction of the Research Integrity & Compliance Officer, the QA/QI Specialist:
Monitors developments and changes regarding the regulatory environment and assists with the interpretation of emerging federal, state and local laws and regulations, as relates to review and oversight of research compliance.
Conducts risk assessments, internal investigations, and operational audits of research related issues to: monitor compliance with federal, state and local laws and regulations and HPHC/I policies and procedures.
Identifies potential research compliance vulnerabilities and makes recommendations to the Research Integrity & Compliance Officer to improve internal controls.
Maintains basic knowledge of applicable standards and regulations to ensure ongoing compliance with accreditation and regulatory standards (AAHRPP, OHRP, FDA, ORI, etc.).
Serves as anchor member of the accreditation team.
Assists with the development, implementation, and maintenance of databases to monitor compliance in assigned areas).Drafts, edits and prepares correspondence, reports, study management tools, dashboards and other material using word processing, spreadsheets and/or dashboards.
Assists with development of and implementation of the annual Research Compliance Work Plan and identification of performance indicators to measure the effectiveness of the regulatory research compliance program at HPHC/I.
Develops, creates and delivers educational training programs, training tools and materials (training aids, newsletter articles, handouts, etc.) on various QA/QI related topics to achieve individual and group learning goals.
Attends training and conferences, as needed, and reviews publications on relevant research compliance program information.
Performs other duties and projects as assigned.
Bachelor’s degree required. Minimum of 3 years’ experience in research QA/QI. Experience auditing IRB/investigator regulatory documentation and/or preparing and/or reviewing IRB submissions. Solid working knowledge of federal and state regulations governing human research and Good Clinical Practice Guidelines. Must be detail-oriented with strong organizational and time management skills. Self-managing with ability to work independently. Must be able to effectively collaborate in a matrix organization and demonstrate ability to work as a team player.
Master’s Degree in related field highly desired. Certified IRB Professional preferred. Strong analytical written and oral communication skills and ability to multi-task in a busy office environment while maintaining superior customer service. Advanced skills with Microsoft applications including Outlook, Word, Excel, Access, PowerPoint and other web-based applications as well as social media platforms including Facebook, Twitter, Instagram, Google, and LiveWire. Ability to produce complex documents, including dashboards, perform analysis and maintain database. Ability to comprehend and communicate complex verbal information in English to HPHC/I employees. Ability to maintain strict standard of confidentiality.
Harvard Pilgrim Health Care Institute located in Boston, Massachusetts is a unique collaboration between Harvard Pilgrim Health Care, Inc. and Harvard Medical School. The Institute's staff includes leading physicians, researchers, clinicians and public health professionals. The Institute's work is dedicated to improving health care delivery and population health through innovative research and teaching.