| IRB Coordinator -- Boston, MA |
Author: Jon Merz
Date: 02-25-10 18:13
Tufts Medical Center, Boston, MA has the following position open:
IRB Coordinator
The Institutional Review Board (IRB) Coordinator, which is part of an integrated team that supports the functions and activities of the IRB, serves as a regulatory resource for investigators and co-workers; as a result, an extensive understanding of human subject research regulations and federal guidance documents is critical. Work is completed in accordance with the processes and procedures that ensure compliance with federal and state regulations and institutional policies relative to human subjects in research at Tufts University/Tufts Medical Center.
The IRB Coordinator is responsible for pre-viewing new research applications for consistency, completeness, and compliance with federal and state regulations and institutional guidelines prior to convened IRB review. Prepares IRB meeting agenda, attends IRB meetings, records and writes IRB meeting minutes and follow-up correspondence to investigators. The IRB Coordinator also conducts similar processes for in-office expedited approval of amendments for previously approved research.
Responsibilities include:
The efficient and timely processing of all new greater than minimal risk research applications and in-office expedited amendment approvals.
Serves as a resource to the research community; works with researchers to answer questions regarding the preparation and submission of new studies and application of institutional policies and procedures to research.
Reviews Informed Consent Forms (ICFs) for protocol and amendment-specific content and to ensure presence of federally mandated elements of informed consent.
Communicates to Principal Investigators items that require clarification, or documents required for submission, to complete a research application for IRB review.
Coordinates a team approach to produce the monthly IRB agenda.
Working with other members of the team attends IRB meetings, records deliberations, and writes meeting minutes.
Writes correspondence to Principal Investigators to communicate the decisions of the IRB.
Coordinates similar functions for the institutional Scientific Review Committee (SRC) and provides administrative support for that committee (i.e., attends SRC meetings and drafts communications conveying the SRC review decisions).
Provides direct guidance and serves as a resource to co-workers in the IRB office.
Assists in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
Maintains positive relationship with IRB customers and co-workers.
Studies for and completes IRB certification.
Attends seminars, workshops and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of increasingly sophisticated technology.
Maintains collaborative team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment.
May participate in or present research-related education sessions.
Performs other job related duties as required or directed.
Works with the Director of IRB Operations on special projects.
Requirements include: BA/BS degree; 1-3 years experience within a research setting with strong preference for prior human subject research experience; excellent organizational and interpersonal skills; strong problem solving skills; able to understand and analyze complex human subject research issues; ability to work independently and interdependently; proficiency with Microsoft Office; excellent oral and written communication skills; ability to work under deadline pressure. Must have mature judgment, as confidential information is routinely encountered.
Please do apply directly to the website:
http://www.tuftsmedicalcenter.org/careers
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