I have been asked by the New England Medical Center of Boston to post this new position. Charlie Tardivo Manager KPMG Higher Education Research Consulting =========================================================================== ==== Director of the IRB Administrative Office GENERAL SUMMARY: This individual is responsible for the leadership and effective management of the Institutional Review Board (IRB) Administrative Office which is responsible for assuring compliance with all federal and state policies that regulate the use of human subjects. The Director is responsible all administrative aspects of the IRB's mandate. This individual will be responsible for strengthening the administration of the IRB review process and for operating the office efficiently in order to support the Tufts and NEMC clinical research programs and the protection of human subjects. This individual will be responsible for the day-to day management and training of the IRB administrative staff. This individual will work closely with Chairperson and Vice Chairpersons of the IRB with an administrative reporting line to the Tufts Associate Provost for Research and NEMC Vice President for Research Administration. DUTIES AND RESPONSIBILITIES: 1. Provide leadership and direction to Tufts and NEMC to ensure compliance with federal and state human subject regulations. 2. Development and maintenance of committee and investigator policies and procedures to assure compliance with all applicable federal and state regulation relative to human subject research. 3. Prepares and monitors budget for administrative office. Assumes responsibility for advising institution on resources required in order to maintain an adequate human subject protection program. 4. Oversees, directs and supervises professional and administrative personnel providing support for the IRB. Hires, trains, supervises and evaluates office support staff. 5. Communicates with other hospital departments and committees to coordinate policy and regulatory compliance, This includes interface with pharmacy, nursing, and directors of the general clinical research center (GCRC), institutional biosafety committee and other departments that conduct or support clinical research. 6. Serves as an institutional expert and resource for all issues pertaining to human subject protections. 7. Provides support to the Committee Chairpersons and institutional officials in operating a human subject program 8. Monitors and communicates Department of health and Human Services,, Food and Drug Administration and state agencies current regulations and serves as a hospital liaison to these agencies. Contact agencies for clarification and or interpretation of regulations. Represents institutions and IRB during funding agency and accreditation site visits. 9. Prepares, maintains and updates institutional assurance as often as required. 9. In conjunction with computer professionals, develops, maintains and manages appropriate information systems to support IRB review process. Develop and maintain web-based materials that support the IRB ( educational materials, policies and procedures) 11. Develop oversee and mange a program of continuing education for humans subject protections for 11RB members, IRB staff and investigators. 12. Create and maintain a high quality service oriented office with attention to budgets, personnel requirements, and space and relate issues 13. Provides ongoing consultation to investigators on issues pertaining to humans subject protections and the IRB review process. Provides advice on issues related to the development of humans subject protocols. Advises investigators about regulations and institutional policies 14. Develops and maintains ongoing monitoring processes of research activities approved by the IRB to ensure compliance with federal mandated regulations protecting the rights and welfare of research subjects 15~ Attends national conferences in order to gain insight into new issues pertaining to human subject regulations and to learn new approaches for application of federal regulations. Network with other IRB professionals as necessary to share issues and solutions to complex IRB issues. 16. Oversees development and maintenance of IRB computer database. Identifies new IRB computer needs and works with appropriate institutional staff to implement necessary modifications QUALIFICATIONS: * A solid, up-to-date understanding of all regulations, and guidelines relevant to IRBs, including knowledge and practical experience with federal regulatory offices including OHRP and FDA- 5-7 years experience in an IRB or research regulatory environment. * * Previous management experience in a research, academic medical center or health care setting highly desirable. Supervisory experience is required. * * Ability to work with policy and regulations and manage the complexity and degree of detail involved in the IRB review process. * * Demonstrated breath of experience in multiple administrative functions including information system, human resources and fiscal management. * * Applicants must be able to function independently, be motivated and have excellent diplomatic skills. Individuals must be able to work in a very fast-paced environment with closely spaced deadlines. * * They must be able to set priorities when they are multiple and conflicting responsibilities. Interpersonal and excellent communication skills are essential. * * BA/BS required. Masters degree in a health and or related discipline desirable. Health care provider background highly desirable. SEND RESUMES TO: Peggy Newell Office of the Associate Provost for Research Tufts University 136 Harrison Avenue Boston, MA 02111 ***************************************************************************** The information in this email is confidential and may be legally privileged. It is intended solely for the addressee. Access to this email by anyone else is unauthorized. If you are not the intended recipient, any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it, is prohibited and may be unlawful. When addressed to our clients any opinions or advice contained in this email are subject to the terms and conditions expressed in the governing KPMG client engagement letter. ***************************************************************************** ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
