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IRB Special Projects Manager

IRB Special Projects Manager

Job ID 
2017-10636
Campus 
Einstein/Resnick - Bronx
Posting Date 
10/30/2017
Employee Classification 
Exempt
Department 
Institutional Review Board
Position Type 
Regular Full-Time

More information about this job

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.

POSITION RESPONSIBILITIES

Lead the institution’s AAHRPP multi-year accreditation project and other special projects, as needed, under the leadership of the IRB’s Associate Director of Education and Compliance.

Serve as primary contact for AAHRPP staff, IRB Director/Associate Directors, IRB staff, IRB members, Office of Clinical Trials, Grants Office, Legal, Office of the Dean, Privacy Officer, joint executive leadership, principal investigators and others to obtain and communicate policies and requirements throughout the AAHRPP accreditation process and for other special projects as needed.  

 

Recommend/implement changes to HRPP and IRB operating procedures and institutional policies in alignment with AAHRPP accreditation standards and to streamline HRPP and IRB operations while maintaining compliance with federal and state regulations.

 

Oversee and prepare all AAHRPP Step One application materials using AccreditStation software, and then oversee and prepare the response to AAHRPP’s review of Step One application.

 

Direct and coordinate all site visits or audits (and related paperwork), including the AAHRRPP site visit.

 

Work closely with IRB Director/Associate Directors, IRB staff, and other HRPP stakeholders to implement and communicate changes to policies and procedures to the Einstein, Montefiore, and Jacobi Medical Center research community.

 

As an adjunct to the institution’s compliance arm, maintain quality assurance of the department, identify deficiencies, and recommend solutions and procedural changes to improve quality and efficiency (such as to our minutes, procedures, meetings, checklists, etc.).

 

Participate in the development and presentation of the IRB Continuing Education Program for faculty, research staff, IRB members, and IRB staff.

 

Manage IRB operations, as needed. 

QUALIFICATIONS

  • Bachelor’s degree required.
  • Graduate degree in a relevant field a plus.
  • Previous research experience desirable.
  • Knowledge of applicable federal and state regulations (including 45 CFR 46, 21 CFR 50, 56, 312, 812) a plus
  • 3+ years administrative experience in human subjects research related work, research compliance, quality assurance/improvement, policy writing, or research/health care project management.
  • Previous experience working on AAHRPP accreditation applications preferred.
  • Previous experience managing short-term, long-term and time sensitive projects.
  • CIP certification a plus. 

Skills and Competencies:

  • Demonstrated administrative skills.
  • Demonstrated project management skills.
  • Must be able to work independently with minimal supervision.
  • Excellent written and oral communications skills.
  • Excellent critical thinking skills.
  • Ability to liaise effectively with various departments and committees at the Institution.
  • Previous experience with Educational/ Compliance programs a plus.
  • Strong familiarity with Microsoft Office (Word, Windows, Excel).
  • Ability to adapt to custom web-based software and databases.
  • Ability to develop and lead educational programs, and to train groups and individuals

Scope of Responsibility

This position will interact with investigators, administrators of several departments, members of the IRB and IRB staff.