• Senior IRB Analyst

    Posting Date 1 month ago(1 month ago)
    Job ID
    2018-11348
    Campus
    Einstein/Resnick - Bronx
    Employee Classification
    Exempt
    Department
    Institutional Review Board
    Position Type
    Regular Full-Time
  • ABOUT US

    Founded in 1955, the Albert Einstein College of Medicine (Einstein) is one of the nation’s premier institutions for medical education, basic research and clinical investigation. A full-time faculty of some 2,000 conducts research, teaches, and delivers health care in every major biomedical specialty. The college has some 730 medical students, 193 Ph.D. students, 106 MD/Ph.D. students and 275 postdoctoral fellows.

     

    Einstein’s major strength, in addition to training physicians and scientists, is its science. During fiscal year 2015, the faculty’s consistently high level of scientific achievement resulted in the awarding of more than $150 million in peer-reviewed grants from the National Institutes of Health (NIH).

     

    Einstein is part of Montefiore Medicine Academic Health System, an integrated academic delivery system comprising seven campuses, including 8 hospitals, a multi-county ambulatory network, a new state-of-the art “hospital without beds”, a skilled nursing facility, school of nursing, home health agency, and the state’s first freestanding emergency department. As the University Hospital for the Albert Einstein College of Medicine, Montefiore is a premier academic health system, employing Einstein’s clinical faculty and training Einstein’s medical students, over 1,300 residents, 420 allied health students, and 1,600 nursing students annually.

     

    The Albert Einstein College of Medicine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Einstein seeks candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence, and the communities we serve.

     

    This position presents an opportunity for an individual with a commitment to the ethical conduct of research and outstanding credentials to assist with the day-to-day operations of the human research protection program at Einstein. The Einstein IRB program now includes Montefiore Medical Center.

     

    The Albert Einstein College of Medicine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Einstein seeks candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence, and the communities we serve.

    POSITION RESPONSIBILITIES

    • Independently conduct the detailed administrative audit and processing of new Full Review studies and amendments (including the informed consent documents).
    • Independently audit and review Expedited submissions to ensure all regulatory elements are found in the submission materials as needed.
    • Attend monthly IRB meetings, write the minutes (ensuring that regulatory requirements are satisfied and documented), and communicate the outcome to the researchers.
    • Provide education to the IRB staff on proper IRB procedures, and regulations.
    • Respond to researcher’s questions regarding policy and procedures.
    • Coordinate appropriate reviews and approvals from other institutional departments/committees including Office for Clinical Trials, Radiation Safety Committee, Conflict of Interest Committee, Finance, and the Clinical Research Center Protocol Review Committee.
    • Participate in the development and presentation of the IRB Continuing Education Program for faculty, research staff, IRB members.
    • Provide support to the research community on the web-based systems related to Expedited/ Full Review applications and amendments. Triage questions appropriately.
    • Responsible to monitor outstanding protocol transactions to facilitate timely approval for new full review protocols.
    • Immediately inform the Director/Associate Directors of significant staff, procedural or protocol non-compliance issues.
    • Recommend changes to operating procedures to work more efficiently and effectively.
    • Oversee the monthly distribution or IRB materials, help prepare the monthly full review agenda, and assist in assigning the primary and secondary reviewers.
    • Assist in the quality assurance of the department, identify deficiencies, and recommend solution and procedural changes to improve quality and efficiency.
    • Draft changes to operating procedures to work more efficiently and effectively for review by the IRB Director/Associate Directors and Joint Executive Committee.
    • Work closely with IRB staff, Director, Associate Directors, Chair, Principal Investigators, and other research staff to ensure the smooth processing of all research transactions.

    QUALIFICATIONS

    • Bachelor’s degree preferred.
    • Graduate degree in a relevant field a plus.
    • 3+ years IRB administrative experience.
    • CIP certification preferred.
    • Strong knowledge of applicable federal and state regulations (including 45 CFR 46, 21 CFR 50, 56, 312, 812).

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