| Research Compliance Manager -- Boston, MA |
Author: Michelle Auerbach
Date: 08-23-09 15:56
The Research Compliance Manager (RCM) in the Office of Research and Sponsored Programs (ORSP) at UMass Boston is a full-time 12-month position appointed by and reporting to the Assistant Vice Provost for Research and Executive Director of ORSP. The RCM is responsible for the oversight and management of research compliance issues within the University to ensure University research employees are complying with federal regulations, state laws and internal policies and procedures. Acting as the principal point of contact for the research community the RCM provides information regarding regulatory compliance issues related to: welfare of subjects and the environment (e.g., human subjects, animal care and use, biological and radiation safety); scientific integrity (e.g., responsible conduct of research, conflict of interest); cost policy (e.g., time and effort reporting, cost sharing, cost principles) and other compliance requirements (e.g., import/export control). The RCM is responsible for developing a culture of regulatory compliance through training, education, strategic risk assessments, audits and other monitoring processes. The RCM is responsible for oversight of the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC) and supervises the IRB/IACUC Administrator. The RCM is responsible for developing an effective compliance training modules for new employees as well as ongoing training modules for the research community.
Examples of Duties:
Ensure compliance and quality assurance through training, education, strategic risk assessments, audits, and other monitoring processes.
Institute and maintain an effective compliance communication program, including promoting heightened awareness of Standards of Conduct and understanding of new and existing compliance issues and related policies and procedures.
Develop, maintain, and revise policies and procedures regarding research compliance and related activities to assure university compliance with rules and regulations related to the responsible conduct of research.
Provide direction and consultation to the research community regarding current issues and ethical concerns associated with the implementation and interpretation of internal and external research compliance regulations, policies and requirements.
Develop and conduct on-going educational workshops and training programs regarding research ethics, policies and procedures, federal regulations and investigator responsibilities to train research staff.
Identify potential areas of compliance vulnerability and risk; develop/implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.
Handle initial concerns, in accordance with university policy and procedure, regarding alleged violations of rules, regulations, policies, procedures, and Standards of Conduct. Assist in developing system for uniform handling of such violations.
Identify and coordinate the translation of revised and new government regulations or guidance into compliant institutional policies for responsible conduct of research and presents such information to the members of the various oversight and compliance committees (e.g., IRB, IACUC), institutional officials, and investigators.
Develop, recommend and implement policies and procedures to enhance efficiency of committee operations including policies and procedures for investigators and standard operating procedures for administrative function of the IRB and IACUC.
Assist in evaluating IRB/IACUC staff performance and participate in the hiring and training of IRB/IACUC staff.
Identify regulatory trends in compliance areas and develop strategies to enable the University to anticipate and successfully adapt to the changes.
Represent the University as a knowledgeable point of contact in audits and deliberations with federal, state, and local agencies or other organizations
Develop and maintain systems for tracking all compliance activities.
Produce all required reports, notices and other documents related to compliance activities.
Prepare periodic reports of compliance activities.
Perform other duties and special projects as assigned.
Minimum Qualifications:
Bachelor’s degree in a field relevant to research compliance and five years progressively responsible experience with regulatory compliance issues related to research, or a Master’s degree or J.D. and three years progressively responsible experience with regulatory compliance issues related to research. Experience in an academic institution is preferred
Expertise in research ethics and the responsible conduct of research.
Extensive knowledge of federal state and local regulations concerning relevant research compliance areas.
Experience in the interpretation of legislation, regulations, policies, procedures, and ethical principles in research compliance is required. The ability to translate regulations into operational policies and procedures is essential.
Knowledge of the broader research environment, including emerging regulatory trends, best practices at other institutions regarding human research protection programs, conflict of interest, responsible conduct of research, and other issues is highly desirable.
Demonstrated expertise in developing and delivering regulatory and compliance training programs.
Ability to work with diverse constituencies within an academic community.
Capacity to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities.
Must be team-oriented, results-driven and able to motivate others.
Must possess excellent communication skills to be able to clearly present complex information to a variety of audiences and communicate effectively with a diverse constituency.
Among the procedures which may be used to select personnel to fill vacant positions are review of work experience, reference checks, and interviews. All qualified applicants will receive consideration without regard to age, race, color, creed, national origin, sex, sexual orientation, disability or status as a Vietnam era or disabled veteran.
Please apply online at:
http://umb.interviewexchange.com/jobsearchfrm.jsp
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Author |
Date |
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Research Compliance Manager -- Boston, MA new |
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Michelle Auerbach |
08-23-09 15:56 |
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