JOB DESCRIPTION

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.

RESPONSIBILITIES

• 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.

QUALIFICATIONS

• 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

REQUIRED SKILLS

Microsoft Office Suite

ABOUT US

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 inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.

• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.

Explore more about this opportunity and how you can help us write a new chapter in our history!

“About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.”

EOE Minorities/Women/Disabled/Veterans

Requisition ID : 3017855