Directs the Cooperative Research and Reliance division of the Office of Human Research Affairs, including reliance and single IRB, research relationships with both affiliated and non-affiliated sites, and acts as aliaison with other internal administrative departments overseeing human subjects research.
Directly supervises multiple positions.
Oversees the reliance process for multisite studies at Einstein and Montefiore Medical Center. Advise and provide consultative services to researchers and research staff to facilitate use of Master Agreements, IRB Authorization Agreements, and Individual Investigator Agreements.
Responsible for oversight of research compliance software and process solution requirements for, at a minimum, the Institutional Review Board (iRIS) and COI (Osprey). This includes development and support of electronic systems to track and monitor regulatory submissions. This may involve multiple systems within and outside of Einstein.
Responsible for partnering with the Office of Grant Support, Department Administrators, the Office of Legal Affairs, and the Office of Research Finance to ensure compliance with regulations governing the conduct of human subjects research.
Works closely with OHRA and Einstein Montefiore leadership to develop policies and processes and stay abreast of changing regulations.
Responsible for providing expertise on educational topics overseen by the Cooperative Research division within Einstein Montefiore for faculty, staff, and students.
Participates in research leadership activities. Oversees programs and direct reports and collaborates with others in the organization.
Recruits and recommends appointments and promotions for supervised staff, defines and reviews responsibilities, and serves as a mentor to junior staff. Responsible for annual staff evaluations.
Recommend/implement changes to operating procedures and institutional policies and technology to maintain compliance with federal and state regulations and national standards.
Responsible for oversight and creation of tracking systems to coordinate institutional administrative reviews for agreements related to human subjects research, including data use agreements and material transfer agreements.
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.
Albert Einstein College of Medicine offers flexible work schedules and a hybrid remote work arrangements for our professional and administrative staff with supervisory approval. The incumbent for this position is eligible for consideration and applicants should inquire.
Bachelor's degree required.
Graduate degree in a relevant field a plus.
5+ 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 required.
Experience with central/single IRB and reliance agreements required.
Previous experience managing short-term, long-term, and time sensitive projects required.
Experience working with various electronic systems related to the management of human subjects research.
CIP certification required upon becoming eligible to sit for the exam.
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, e...mploying 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.