Index/Position No.:                             24550/594290                                     Level 6

Position Title:                                      Institutional Review Board (IRB) Coordinator

Department:                                        Research and Sponsored Programs

Expectations for All Employees

East Tennessee State University pursues its mission based upon core values.  An employee's job performance must support and exhibit the university's core values:

PEOPLE come first, are treated with dignity and respect, and are encouraged to achieve their full potential;

RELATIONSHIPS are built on honesty, integrity and trust;

DIVERSITY of people and thought is respected;

EXCELLENCE is achieved through teamwork, leadership, creativity, and a strong work ethic;

EFFICIENCY is achieved through wise use of human and financial resources; and

COMMITMENT to intellectual achievement is embraced.

Function of Position

This position is responsible to the Director of Human Subjects Research Protection Program for reviewing all submissions to the Institutional Review Board (IRB) to ensure that IRB members have all the requisite information to review human subject research; enabling the IRB board members, including the IRB Chairs, to perform their review tasks by providing the necessary documents and education; acting as intercessory between the boards, researchers and other involved institutions; and performing other related duties as assigned.

Essential Functions

-           Reviews complex scientific research protocol documents and identifies regulatory issues and communicates those issues to Institutional Review Board (IRB) Chairs, members and study staff with the goal of resolution.

-           Reviews all applications to the IRB, including informed consent, to determine completeness and consistency with federal guidelines and institutional requirements.

-           Prepares items for review by IRB Chairs, obtaining any needed information and material.

-           Determines and compiles meeting agendas to meet distribution deadline, disseminates meeting agendas and packets, coordinates and attends meetings.

-           Records the decision making process of the IRB in official minutes, capturing and documenting summarization of any controverted issues and their resolution, clearness about the actions of the IRB and exactly what the IRB approved,  clear specification of any modifications required to obtain approval, degree of risk, specific required determinations, members present at the meeting, members entering and leaving the meeting, alternate members attending and for whom they are substituting, votes on actions, names of IRB members who abstain, names of IRB members who absent themselves due to conflict of interest, attendance at the meeting for each action, basis for IRB requiring change in research, basis for disapproval of research, the rationale for significant or non-significant risk determinations, approval periods, and other regulatory requirements.

-           Provides guidance and training to investigators and research staff regarding procedural requirements for submission to the IRB.

-           Interfaces with other ETSU departments and other institutions, including problem-solving at institutional levels in addition to the individual investigator level.

-           Verifies that appropriate documentation is obtained before final IRB approval is issued, including ensuring presence of education requirements for all study staff, required documentation for all external performance sites, and required documentation for investigational drug or device numbers.

-           Assists with revisions and implementation of IRB forms, Policies and Procedures, as well as other resources for the research community.

-           Ensures that protocols undergo continuing review within current approval period and issues expiration letters for those whose approval lapses.

-           Communicates results of IRB reviews to Principle Investigator and drafts other correspondence as needed in an organized, clear, concise manner.

-           Interacts positively with research participants, and the research community, and appropriately addresses issues, including complaints.

-           Maintains and audits IRB records and files.

-           Gathers information and material in response to inquiries, and responds to requests for information regarding IRB review.

Leads special projects as assigned by Director.

-           Assists in identifying areas of focus for education topics and presents workshops for the university community and affiliates on IRB Policies and Procedures.

Maintains strict confidentiality.

Secondary Functions:

Prepares IRB annual report.

Maintains office filing system and databases.

Assists in arranging accommodations for site visitors and guest speakers.

-           Assists the Vice Provost for Research and the Director for Human Research Subjects Protection Program as needed in review of accusation of scientific misconduct and production and dissemination of material regarding federal regulations and university policy regarding scientific misconduct related to research involving human subjects.

 Participates in required human subject training.

 Assists with supervision of student workers.

-        Performs other related duties as assigned

Knowledge and Abilities

-        Ability to prioritize and organize multiple tasks in a detail-oriented environment

-        Ability to guide the research community members, communicating detailed information professionally and with brevity, both orally and in writing

-        Ability to extrapolate requirements from regulation and IRB Policies and Procedures and provide guidance for the research community.

-        Ability to plan and present educational sessions to diverse groups of students, faculty, staff and other constituencies

-        Ability to adapt to new, various software and applications

-        Ability to work effectively under deadlines, often in a high-pressure environment

-        Ability to work and make decisions independently, as appropriate

-        Ability to work effectively with all university constituents and affiliates

Supervision Given and Received

Performs under general supervision. Determines own methods of performing assigned work.

Minimum Qualifications

Bachelor’s degree; knowledge of human subjects regulatory compliance; exceptional computer skills including word processing, database and presentation skills; one to two years of administrative experience in academic research required.

May 2008