| IRB Regulatory Specialist II/III -- Silver Spring, MD |
Author: Jon Merz
Date: 07-15-08 11:57
Position Vacancy
Children’s National Medical Center, Washington, D.C.
Office for the Protection of Human Subjects
IRB Regulatory Specialist II/III
CNMC is recruiting a qualified subject matter expert in the Office for the Protection of Human Subjects office located in Silver Spring, Maryland.
This position is responsible for providing professional support to the Children’s National Medical Center Institutional Review Board (IRB). Conducts protocol pre-reviews. Applies knowledge of human subject protection regulations and institutional policies to manage IRB meetings and provide consultation/education to investigators and research staff. Communicates IRB decisions and rationale to investigators.
Key Responsibilities: IRB Regulatory Specialist-II/III
• Provide professional service to the IRB Chair, IRB Committee, and clinical investigators.
• Pre-review all types of research protocol submissions to ensure that individual research protocols involving human subjects are in compliance with federal regulations and guidelines, state laws, and CNMC policies and procedures for conducting research.
• Generates regulatory compliance pre-review o full board and expedited protocol submissions and communicates with investigator to revise submission sufficient for IRB review.
• Develops meeting agenda and supplemental materials; meeting packets, minutes and correspondence for the fully convened IRB.
• Attend meeting to capture IRB discussion and determinations. Serves as a subject matter expert to the IRB by providing ethical, regulatory and institutional guidance as needed.
• Compose meeting minutes that accurately document the determinations of the IRB to include complex and controverted and regulatory based issues.
• Following the IRB meeting, generate correspondence to investigators that conveys IRB deliberations in a thorough and accurate manner. Correspondence should require minimal input or revision by supervisor.
•
Education and Training Required
Minimum Bachelor’s Degree; Master’s Degree preferred. CIP (Certified IRB Professional) Certification preferred -- If not currently certified, must be obtained prior to the end of a 12-month employment term.
Experience Required
Minimum 3 years experience in IRB/research administration. Requires three years of IRB office related experience, preferably as an IRB or IACUC administrator using critical thinking, reasoning, problem solving and communication skills.
The Office for the Protection of Human Subjects is located in Silver Spring, MD.
For more information, Birdena Samuel, CIP at bsamuel@cnmc.org or 301-565-8488
Children’s National Medical Center Website: http://www.childrensnational.org/
|
|
|
