| IRB Auditor -- New York, NY |
Author: Jon Merz
Date: 10-05-11 23:04
The Columbia University (CU) and Columbia University Medical Center (CUMC) are committed to excellence in education, research, and patient care. The Columbia Institutional Review Board (IRB) office currently administers five IRBs, a compliance oversight program, and education training initiatives with a staff of 26 individuals. The IRB office manages the review of about 1,400 new protocols a year. CU/CUMC has been committed to a state of the art comprehensive human subjects protection program.
The CU IRB is now recruiting an IRB Auditor to serve on its Compliance Oversight Team (COT). The IRB Auditor reports to the Compliance Oversight Team Manager, Columbia University (CU) IRB.
• This staff member will join a team of other professionals who are responsible for compliance activities including conducting for-cause and not-for-cause audits, reviewing external monitoring reports, managing subject complaints, drafting reports of investigations, and drafting reports of noncompliance activities for appropriate regulatory agencies.
Other responsibilities include:
• provide professional support in conducting pre-review of submissions to all CUMC IRBs; in this capacity the staff member will report to the Associate or Executive Director, IRB.
• Serve on one or more Office Committees (e.g., Education Training; Policy, RASCAL, etc.). In this capacity the staff member will report to the Associate or Executive Director, IRB.
• Must maintain up to date knowledge of state and federal regulations and institutional policies, as well as guidelines and ethical codes related to the protection of human subjects in research.
• May also conduct quality control functions for the IRB office in all areas of the operation including reviewing minutes of the meetings for accuracy and consistency. This staff member will also work with other IRB officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations
• Other work as assigned.
Minimum qualifications:
Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience.
Additional Position-Specific Minimum qualifications:
Either prior experience with auditing/monitoring biomedical or behavioral human research or 2) prior experience in managing clinical trials is essential. Strong interpersonal, communications, writing skills, and experience with computerized databases and word processing required.
Preferred Qualifications:
Prefer prior auditing or clinical research experience. Familiarity with state and federal regulations related to human subjects protection is preferred. Certification as an IRB professional is a plus.
How to apply:
You may apply for any of these positions at our Human Resources website at: http://www.columbia.edu/cu/jobs/ (click "Jobs at Columbia" under "Job Links", then select "Search Open Positions" on the left menu, Enter "037 Institutional Review Board" under "Department".
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| Topics |
Author |
Date |
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IRB Auditor -- New York, NY |
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Jon Merz |
10-05-11 23:04 |
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