Director, Regulatory & Administrative Affairs - International Center for Health Outcomes & Innovation Research (Remote)

International Center for Health Outcomes and Innovation Research (InCHOIR) is a clinical and data coordinating center with an interdisciplinary faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety and Monitoring Board management. In addition, faculty has expertise in data management, statistical analysis, health economics, and FDA-compliant web-based electronic data capture systems.

The trials that InCHOIR faculty have conducted over more than a decade past, beginning with the REMATCH trial that established LVADs as destination therapy for advanced heart failure patients, have shaped treatment paradigms. Our recent research in the surgical treatment of ischemic mitral valve disease and atrial fibrillation which was recently published in a series of papers in The New England Journal of Medicine, is changing recommendations for the use of these interventions. Since 2008, the Center has been awarded over $91 million in federal and industry funding.

This position is responsible for translating regulatory knowledge relating to human research, including federal, state, local and international laws and regulations into effective policies that contribute to productive, efficient, responsible research conduct within the Department of Health Policy and Science which is part of the Icahn School of Medicine at Mount Sinai. Responsible for the design, implementation and quality oversight of major regulatory programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and the Principal Investigator of InCHOIR.

• Organizes the portfolio of U.S. and International regulated clinical trials (Cardiovascular, Infectious Disease, Neurovascular, Orthopedics, etc.)
• Ongoing management and mentorship of junior regulatory staff
• Hiring and training new staff
• Development of training protocols
• Working with local and central IRBs, Ethics Committees the FDA, Health Canada, European Regulatory Authority and CMS
• Creating new IRB submissions and renewals for ongoing trials
• Organizes edits or develops policies and procedures related to human research activity to facilitate understanding and ease of use by investigators and support the research agenda.
• Performs analytical and evaluative work associated with program activities; develops procedures and systems for establishing, operating and assessing the effectiveness of internal review systems; prepares reports relative to office and departmental activities as necessary.
• Reviews all procedures that currently impact the regulation of the clinical trial research portfolio of the Department and suggests corrective action plans where necessary.
• Coordinates with the clinical trial sites to conduct for cause and random audits of records/sites of active and inactive IRB protocols to ensure compliance with federal and institutional mandates concerning the conduct of research (e.g. informed consent) and provide feedback on corrective action plans as needed.
• Facilitates production of informative guidance for research staff to elucidate salient issues in human research protection.
• Directs the development of standard language templates (e.g. macros) for communication.
• Supervises the electronic IRB submission process for all trials.
• Assists in the design of more effective and efficient means of communications with researchers (postings, approval letters).
• Manages the current database and reporting system, all upgrades and reporting, and any migration of data to future systems.
• Manages the electronic trial master file managements system.
• Manages the electronic list-serve of research staff for dissemination of information.
• Supervises the coordination of site visits/inspections as necessary.

• Bachelors Degree in Administration, or related field Masters preferred
• 7 years experience in a research related professions including 3 years of management experience 
• Previous experience in IRB
• IRB Certification

 

 

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:  

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
• Serving as a role model confronting racist, sexist, or other inappr