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

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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

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