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.
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 IRB Administrator will aid in ensuring that Einstein remains compliant with Institutional policy and federal, state, and local rules and regulations, and ethical principles pertaining to the Institutional Review Board (IRB) and Embryonic Stem Cell Research Oversight (ESCRO) Committee.
- Serve as a primary point of contact and source guidance for single IRB review and reliance/master agreements. Advise and provide consultative services to researchers and research staff to facilitate use of Master Agreements, IRB Authorization Agreements, and Individual Investigator Agreements.
- Receive requests from Einstein researchers to rely on an external IRB or allow reliance on the Einstein IRB. Conduct a review of all request applications that are submitted. Advise investigators to plan for appropriate infrastructure and staffing necessary for a multi-center trial.
- Responsible for analytical and administrative review and approval of studies being considered for reliance/single IRB requests. This may include tasks such as:
- making determinations about engagement of institutions or individuals in research
- reviewing HIPAA Authorization language to ensure validity and determining when HIPAA Waivers or Data Use Agreements are required
- making determinations as to the appropriate credentials of the research investigators and research team in order to work cross institutionally, if applicable
- determining whether to utilize one or multiple consents for each institution
- obtaining information from or proving information to external institutions regarding institutional polices and applicable state regulations
- Review, update, and coordinate release and receipt of local context worksheets for master agreements
- advising researchers or reliance staff about necessary additional ancillary reviews that may need to occur at the pertinent institutions
- Manage protocols involving other institutions or individuals. This includes advising investigators on developing protocols, and reviewing initial submissions, continuing reviews, amendments, and unanticipated problems.
- Work closely with the IRB Director and Associate Director of IRB Education and Compliance, as well as the Assistant Dean, Legal Counsel, and external contacts, to prepare, negotiate, coordinate and track IRB review and documentation pertinent to the use of IRB reliance/master agreements.
- Work closely with the IRB Director and Associate Director of IRB Education and Compliance to develop policies, procedures, SOPs, practices, and forms to facilitate and streamline the reliance /master agreement review process.
- Develop and implement training/educational materials for the research community (e.g. how to submit), as well as training and education for staff on how to review and process protocols covered by an authorization agreement.
- Develop and support electronic systems to support review tracking and monitoring for ongoing activities. This may involve multiple systems within and outside of Einstein.
- Participate as a key stakeholder in the ongoing development and improvement of Einstein/Montefiore research compliance program.
- Assist in the quality assurance of the department, identify deficiencies, and recommend solutions and procedural changes to improve quality and efficiency.
- Maintain IRB and compliance-related web content.
- Bachelor's degree required.
- Graduate degree in a relevant field a plus.
- 2+ years administrative experience in human subjects research related work, research compliance, quality assurance/improvement.
- Strong knowledge of applicable federal and state regulations (including 45 CFR 46, 21 CFR 50, 56, 312, 812) required.
- Strong understanding regarding engagement in research required.
- Strong knowledge of HIPAA for research regulations.
- Experience with central/single IRB and reliance agreements desirable.
- Previous experience managing short-term, long-term, and time sensitive projects.
- CIP certification strongly preferred.
Skills and Competencies:
- Demonstrated ability to work independently on detailed analyses of complex policies, regulations, statutes and guidelines, problem solve and follow through on assignments with minimal direction.
- Ability to communicate effectively both orally and in writing with diverse internal and external constituencies.
- Demonstrated administrative skills.
- Demonstrated project management 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.