| IRB Administrator -- Erie, PA |
Author: R F
Date: 05-26-10 18:44
IRB Administrator Position
Hamot Medical Center Institutional Review Board
Erie, PA
To apply: www.Hamot.org
PURPOSE OF POSITION
To administer the Institutional Review Board (IRB), ensuring compliance with pertinent federal regulations from the Food and Drug Administration, Health and Human Services, and the Office for Protection from Research Risks.
QUALIFICATIONS
Education/ Experience: BS or BA in health care or related field; five years of Institutional Review Board administration and/or experience; Certified IRB Professional or certification-eligible from the Applied Research Ethics National Association or comparable professional group.
Skills: Must have working knowledge of federal regulations and guidelines related to research and excellent organizational, communication, and interpersonal skills
PRINCIPAL ACCOUNTABILITIES
Essential Functions
1.Human Protections Administrator per Federalwide Assurance: maintains a high level of awareness regarding the ethical conduct of research; safeguards the rights and welfare of human subjects; educates researchers regarding research regulations, policies, and procedures; processes federal forms related to IRB; reports serious/continuing noncompliance with regulations and suspension/termination of IRB approval to institutional officials, federal government and others, as required.
2.Responsible for human research oversight. Monitors and implements research approval process. Forwards research contracts for legal review. Prepares and/or reviews all applications to IRB to ensure they meet federal standards and institutional policy; provides periodic review of all on-going protocols; informs IRB of serious adverse events and unanticipated problems reported by investigators; provides expedited and exempt reviews.
3.Maintains knowledgeability and promotes Hamot’s compliance with human subject regulations issued by FDA, OHRP, and HHS. Provides bi-annual review/update of the IRB Policy and Procedure Manual. Develops/updates administrative research policy, as needed. Provides an annual audit of active IRB files. Participates in on-site reviews of IRB procedures/records by federal inspectors.
4.Develops, implements, and monitors initial and continuing education program for investigators, coordinators, and IRB members. Orients new chairperson or members in IRB procedure.
5.Performs all IRB administrative duties including arranging meetings, preparing agendas and meeting packets, recording minutes, maintaining records, and providing required correspondence as specified in federal guidelines.
6.Applies critical analysis and technical expertise to evaluating research projects submitted to IRB.
7.Performs quality assurance audits on IND, IDE and HUD projects.
8.Participates in ongoing continuing education to keep abreast of developments in the field.
9.Demonstrates Hamot’s commitment to Service Excellence by understanding the needs of patients, their families, physicians and co-workers and doing what is required the first time, every time by being responsible, sensitive, accurate, timely, coordinated and thorough.
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Author |
Date |
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IRB Administrator -- Erie, PA |
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R F |
05-26-10 18:44 |
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