Click here to apply to work for one of the best Universities in America: Drexel University
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Posted By: Hija Chang on May 23, 2013 FEATURED Content The Executive Director, Human Research Protection (HRP) is a senior management position within the Drexel University Office of Research Administration and reports directly to the Senior Associate Vice Provost (SAVP) for Research Administration. The position requires vision, demonstrated leadership, and a thorough understanding of federal and state regulations pertaining to human research protection programs (HRPP). The position has oversight of the staff, processes, and systems related to the administration of: Institutional Review Board (IRB); the Quality Assurance/Quality Improvement Program (QA/QIP); Radiation Safety; BioSafety; and the Institutional Animal Care and Use Committee (IACUC). Furthermore, the position is responsible for the support of three (3) Institutional Review Boards (IRB) and one (1) contract IRB; IACUC; Radiation Safety Committee; BioSafety Committee; and the Responsible Conduct of Research (RCR) Program. She/he collaborates with the SAVP in developing and updating University policies and procedures related to research and other sponsored projects, and implementing changes promulgated in federal and state regulations. The Executive Director ensures program accountability for federally mandated research and sponsored project review committees, and maintains compliance with federal regulations and state laws applicable to projects involving the participation of human subjects. This position also serves as the primary contact with federal agencies such as the Department of Health and Human Services-Office for Human Research Protections (HHS-OHRP) and the Food and Drug Administration (FDA). Essential Function: Oversee the Human Research Protection Program that serves Drexel University, and provides operational support and regulatory expertise to the IRB, IACUC, Biosafety, and Radiation Safety Committees. Develop and manage an organization that provides excellent customer service that effectively and efficiently processes protocols through the regulatory review process. Oversee the preparation of materials for committee and board meetings to ensure protocol is followed including development of meeting agendas and maintenance of confidential records. Also, manages the documentation of committee actions to ensure compliance and accountability including board committee meeting minutes and deliberations. Oversee the university wide Quality Assurance/Quality Improvement (QA/QIP) Unit. Independent of the IRB, the Unit is responsible for monitoring regulatory changes and recommending institutional responses to ensure compliance, and oversees development and implementation of policies, procedures, programs and educational activities which satisfy federal, state, and institutional regulations governing the conduct of research. Responsible for reviewing and revising research and sponsored projects policies to ensure compliance with all applicable regulations and university policy. Works with the responsible university officials to draft research policy and make recommendations to the SAVP for policy approval and implementation. Ensure policies and procedures are reviewed and revised in a timely manner. Implement programs to maintain compliance with regulations and develop comprehensive human subject protection education and certification programs including Responsible Conduct of Research (RCR) Program. Also, partners with the research community (Senior Leadership, Principal Investigators, Research Coordinators, Research Personnel, IRB Coordinators, and Staff) to design programs/resources to contribute to the success of the research enterprise and promote awareness, communication and understanding of HRPP. Create goals, objectives, educational outreach and accreditation efforts related to the research enterprise. Work collaboratively with research areas regarding compliance with all pertinent local, state and federal regulations related to research. Oversee and participate, as needed, in investigations of alleged violations and respond to requests for documents from multiple sources related to HRP. Participate in special projects that will support and enhance the ability of achieving and maintaining Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation status. Bridge open relations with OHRP and Academic Regional partners and provide community awareness through educational programs. Provide leadership in establishing annual operating goals and objectives for the HRPP and metrics whereby performance outcomes will be measured. Identify and implement operational improvements and efficiencies. Work closely and advise the SAVP on the development and monitoring of annual operating budgets for the HRP function and the development of new program or initiative budgets throughout the year, as appropriate. Initiate and enhance business partner concept with other administrative, academic, and ancillary departments by meeting regularly with clients and constituents to determine issues, solve problems and plan for future needs. Act as a spokesperson for Research both internally and externally. Represent Drexel University in collaborative efforts involving research with Academic and Research Affiliates and Industry Partners. Click this link to view and apply for this job! If you enjoyed this article, Join HBCU CONNECT today for similar content and opportunities via email! |
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Hija Chang
Management, See Moss Interactive Bellarmine University class of 2021 Member Since January 2011 |
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