| IRB Analyst -- New York, NY |
Author: David Berkovitz
Date: 07-25-11 20:35
The New York University School of Medicine and Langone Medical Center Institutional Review Board (IRB) is seeking an IRB Analyst.
Reporting to the Scientific Research Manager I of the IRB, the Analyst pre-reviews expedited continuations, continuation under category 8 and amendment submission action items. The Analyst evaluates the action items to determine consistency with IRB requirements for approval and will work with researchers to correct deficiencies prior to final review by the SRM - I. The Analyst works closely with the SRM-I to ensure that post approval expedited items are processed within the expected turn around time.
Responsibilities:
- Conduct pre- reviews of all expedited continuation, amendment and response (CR and AMD) submission items.
- Verify the completeness and accuracy of each submission item and the required documentation in accordance with IRB policies and procedures and federal regulations
- Conduct regular follow-up with PIs on all outstanding issues resulting from pre-review for all continuations, amendments and responses.
- Recommend full board review to SRM of any submission not eligible for expedited review. Relay this decision to PI both verbally and through official IRB correspondence in electronic mail format.
- Provide guidance and assistance to the research staff to educate and assist them in their activities.
- Ensure all decisions are relayed to PI through official IRB correspondence in electronic mail format.
- Ensure that all review communications are relayed to PI and research team.
- Ensure that all submissions are addressed and responses made to researchers in timely manner in accordance with IRB turn around requirements.
- Develop power point presentations and participate in education and training sessions for research community. This will require working with Senior Scientific Community Manager.
- Obtain CIP certification within 1 year of employment or within one year of completing eligibility.
- Assist the SRM with special projects, policy and process formulation and protocol specific issues.
Qualifications:
The position requires the following:
BA/BS required or 2 years working experience within an IRB Administrative Office performing similar responsibilities.
Prior experience overseeing work flow processes is preferred, Excellent interpersonal skills,
Demonstrably skills in professional oral and written communication, Able to deal efficiently and effectively with high volumes, rigid deadlines, and frequent changes. Working knowledge of regulations governing humans subjects research. Ability to interpret regulations, apply regulations to written protocols, and convey information verbally and in writing to faculty and staff. Ability to set priorities and manage time effectively. Ability to perform multiple tasks at any given time with a high level of accuracy and attention to detail. Diplomacy and strong customer service skills and knowledge.
Independent initiative.
Ability to work with all levels of employees in a respectful and supportive manner.
Highly proficient with MS Outlook, Word and Excel, with a working knowledge of MS Access.
A commitment to help maintain a positive, productive and healthy office environment.
Certifications:
Certified IRB Professional or must be able to obtain certification as an IRB Professional within 24 months of hire.
ABOUT NYU School of Medicine:
Founded in 1841 NYU SOM is one of the nation's leading centers of advanced biomedical learning, spans a history of excellence of more than 160 years in the education and training of physicians, in patient care, and in scientific research.
NYU SoM/LMC IRB/ HRPP has received full AAHRPP Accreditation March of 2008.
CONTACT
to learn more, contact: David Berkovitz, M.D. Research Manager and Team leader for Board C- via email:
david.berkovitz@nyumc.org
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| Topics |
Author |
Date |
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IRB Analyst -- New York, NY |
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David Berkovitz |
07-25-11 20:35 |
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