| Quality Assurance Coordinator, IRB -- Bronx, NY |
Author: Jon Merz
Date: 03-08-10 19:01
Yeshiva University
Quality Assurance Coordinator, IRB
Bronx, New York
Company Description:
Yeshiva University, ranked in the top tier of universities nationally, offers rewarding and challenging employment opportunities to qualified candidates in a wide range of disciplines. Founded in 1886, Yeshiva University has a strong tradition of combining Jewish scholarship with academic excellence and achievement in the liberal arts, sciences, medicine, law, business, social work, Jewish studies, education and psychology. The University offers an excellent compensation package, and a broad range of employee benefit plans, including immediate participation and full vesting in the University's retirement plan. Staff members are typically eligible for four weeks paid vacation each year.
Job Description:
The Committee on Clinical Investigations (CCI) is the Institutional Review Board (IRB) for Yeshiva University, Jacobi Medical Center and North Central Bronx Hospital. The CCI reviews all proposals for human subject research and monitors the research in compliance with all applicable regulations.
The Quality Assurance Coordinator manages the Quality Assurance Program through education, review, and monitoring/auditing to ensure adherence with Federal, State, and local regulations and institutional policies in the conduct of research. The Coordinator develops and maintains collaborative relationships with scientific community to facilitate compliance.
* Participate in the selection of protocols for routine, educational, and "for cause" site visits/audits
* Perform on-site review for subject safety and protocol compliance; prepare site visit reports for review and follow-up on non-compliance issues
* Assist researchers in the development of corrective/preventative action plans for non-compliance and monitor the implementation of plans
* Perform internal monitoring/auditing activities for CCI policies and procedures
* Perform an initial review of adverse event reports, identify deficiencies, notify sites of deficiencies and follow-up; ensure that adverse events are reported, when applicable
* Oversee the correctness and timeliness of the AE process by the CCI support staff
* Perform review of new research applications for investigator initiated studies intended for Full Committee review; review informed consent development and provide recommendations for researchers; hold membership in various research review committees
* Identify educational needs of those involved in research and provide education that meets the needs of the institution and investigative sites
* Participate in CCI Continuing Education Program
Job Requirements
* RN or LPN and at least 3-5 years Clinical Research experience required
* Certified IRB Professional (CIP) preferred
* Masters Degree preferred
* Familiarity with Microsoft Office (Word, PowerPoint, and Excel). Ability to learn custom web-based software.
* Working knowledge of Federal regulations for human research (21 CFR parts 50, 56, 312, and 812; and 45 CRF 46).
* Excellent organizational, interpersonal, time management, communication and writing skills.
* Ability to develop and lead educational programs, and to train groups and individuals.
* Ability to exercise sound judgment and initiative in collection of information from a wide variety of sources.
* Ability to work independently and in a team-oriented environment, and to work effectively and diplomatically with all levels of staff in a professional manner.
EOE.
Apply online at: http://www.Click2Apply.net/pztzs8w
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