| Regulatory Affairs Operations Officer -- Boston, MA |
Author: Jon Merz
Date: 01-19-10 22:37
Duties And Responsibilities: The Harvard Clinical and Translational Science Center (CTSC), known as Harvard Catalyst, will facilitate clinical and translational research throughout the 27 Harvard schools and Academic Healthcare Centers (Massachusetts General Hospital, Children's Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana Farber Cancer Institute, and others) by lowering barriers to inter-institutional research, providing seed funding for collaborative experiments, and helping trainees and faculty gain access to resources. Harvard Catalyst's annual operating budget exceeds $38 million, funded by the NIH and the participating Harvard institutions. The complex regulatory environment of C/T research is difficult at Harvard: each institution is a distinct corporate and legal entity with exceptionally robust, comprehensive human research protection programs (HRPPs). The CTSC provides significant opportunities for regulatory collaboration, streamlining, and process improvement, which will lower the barriers to inter-institutional research collaboration. The Regulatory Affairs Operations Officer reports to the Director of Regulatory Affairs Operations. The Regulatory Affairs Operations Officer will research and implement recommendations to harmonize and simplify policies and procedures across Harvard and its affiliated institutions related to regulatory issues in clinical and translational research. These will include, but are not limited to review of policies and procedures in other areas of regulatory compliance such as: (1) the protection of human subjects, (2) protections of privacy and data sharing, (3) subject matter expertise for Regulatory HIPAA across all CTSC entities, and (4) Quality Assurance and Quality Improvement for human research monitoring and audit. The incumbent identifies, recommends and initiates program improvement through on-going assessment and evaluation; conducts literature searches and prepare overheads and PowerPoint for presentations and conference materials; acts as program spokesperson and attends meetings on behalf of the program; conducts research to support CTSC analyses and reports; catalogs, documents, organizes and updates data and maintains databases; coordinates with CTSC entities as appropriate to conduct analytical research; maintains the CTSC Regulatory committees in particular Data Protection and Security; serves as a liaison between various internal and external constituencies to promote collegial relationships; and other duties as assigned by the Harvard Catalyst leadership. This position is a grant-funded position through April 30, 2013.
Basic Qualifications: Qualified candidates will have a B.S. or B.A., three + years of project management experience or working knowledge of theories, principles and concepts typically acquired working in a clinical research setting, academic research or health care environment related to research administration.
Additional Qualifications: Understanding of research compliance, Institutional Review Boards, Human Research Protection Programs, Institutional Animal Care and Use Committees and/or privacy and data-sharing regulations preferred. Demonstrated experience working with multiple internal and external constituencies in setting agendas and implementing policies in a large decentralized institution. Proactive, time-sensitive, results-driven approach in carrying out assigned and assumed responsibilities, and possess the ability to handle multiple, often competing tasks, simultaneously with grace and good humor to obtain group goals. Must be able to build consensus among diverse constituencies and manage multiple priorities. Familiarity with Harvard processes and procedures a plus.
Apply Online at http://jobs.harvard.edu/jobs/summ_req?in_post_id=42933
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Regulatory Affairs Operations Officer -- Boston, MA new |
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Jon Merz |
01-19-10 22:37 |
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