| IRB Manager -- Bronx, NY |
Author: David Wallach
Date: 07-28-11 13:38
The Albert Einstein College of Medicine of Yeshiva University IRB is seeking a Manager for the IRB based at Montefiore Medical Center.
This position is responsible for new submissions to one of two IRBs.
MAJOR DUTIES AND RESPONSIBILITIES
- Pre-review new studies, and assist the IRB Analysts in ensuring appropriate IRB review;
- Pre-review all new Exempt and Expedited studies to ensure all regulatory elements are found in the submission materials.
- Attend 1 IRB meeting per month and oversee appropriate documentation of convened IRB decisions (agendas, letters, and minutes);
- Record minutes for IRB meetings.
- Processing of Deviations and Emergency Use requests.
- Work with the administrative staff of affiliate research committees (CRC, PRMC, COI) to identify deficiencies in studies;
- Assist with implementation of technologies (iMedRIS)
- Provide education to research community and IRB members.
- Work with the IRB senior management team on special projects, policy formulation and protocol specific issues (audits, regulatory compliance).
The IRB Manager reports to the IRB Director.
QUALIFICATIONS
Education: BA/BS required. Masters Degree, a plus.
3-5 years of experience and knowledge directly related to IRB issues and human subjects research protection or equivalent combination of experience and education (typical experience might include ethics, clinical trial performance -industry or sponsor-investigator, and/or experience in an academic health center or medical school IRB), knowledge of applicable federal regulations related to IRB and clinical research; demonstrated administrative skills; must be able to work independently with minimal supervision; excellent written and oral communications skills; excellent customer service skills. Certification as an IRB professional (CIP) is highly desirable or will be required within 12 months of employment.
Character Traits
- “Hands on” leadership style
- Service minded and execution driven (can get things done)
- Excellent project management skills
- Attention to detail (high integrity, analytical))
- Strong relationship builder and good communicator (responsiveness to clinical and business community)
Qualified candidates should contact david.wallach@einstein.yu.edu. To apply for this opportunity online, visit http://careers.montefiore.org/apply.php?job_num=14402 .
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| Topics |
Author |
Date |
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IRB Manager -- Bronx, NY |
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David Wallach |
07-28-11 13:38 |
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