**Job Description** The Assistant Director will oversee the regulatory component of the human research protection program at Mount Sinai. Responsible for all regulatory knowledge relating to human research, including federal, state, and local laws and regulations. Implements policies to contribute to productive, efficient, responsible research conduct at Mount Sinai. **Qualifications** + Bachelors Degree in Health Care Administration, Public Administration or related field; Masters Degree preferred. + 5 years minimum experience, preferably in a health care setting + 2 years of management experience + Certified IRB Professional (CIP) required + Proficiency in MS Office **Responsibilities** + **Federal Wide Assurance Management and Compliance** + Oversee the maintenance of the terms of the FWA with the Office of Human Research Protections, including updating the Institutional Official (currently the President/CEO of Mount Sinai Medical Center) regarding modifications to the terms of the assurance. + Retain inter-institutional agreements for human research protection oversight when appropriate. + Obtain approval of the Institutional Official on all such agreements. + **Manages Reliance Program** + Oversee the management of a robust IRB Reliance program.Oversee the Institutional requirements related to reliance agreements and the reliance process, liaise between all parties. + Manage external IRB review process including contract negotiations between outside entities and the PPHS office. Act as the liaison between researchers and external IRB organizations. + Implements procedures and practices designed to promote compliance with other regulatory processes. + Manage and provide guidance to the Reliance team of IRB Analysts. + **Policy Development** + Oversee the preparation process for obtaining and maintaining the program of accreditation by a national organization using the model system from AAHRPP and institutional policies. + In coordination with senior leadership, developing current Mount Sinai policies and procedures related to human research activity, including, but not limited to the Investigator’s Manual and the MSSM SOPs/forms/worksheets/checklists. + **Program Quality Analysis and Improvement** + Perform analytical and evaluative work associated with program activities; develop procedures and systems for establishing, operating and assessing the effectiveness of internal review systems; prepare reports relative to office and IRB activities as necessary. + Collaborate with the Associate Dean to oversee the workflow processes to assure that the MSSM IRB SOPS support an efficient and high-quality human research subjects’ protection program. + Prepare and implement new forms/processes to increase the quality and efficiency of the process as appropriate. + Coordinate with the Compliance Office 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. + Serve as regulatory advisor to the IRB chairs/researchers/PPHS office + Facilitate production of informative guidance for MSSM research staff to elucidate salient issues in human research protection. + Coordinate the development of standard language templates (e.g. macros) for IRB communication. + **Manage relationships with internal and external entities** + Coordinate appropriate management of interrelated aspects of research regulation at Mount Sinai in concert with IRB leadership and heads of various MSSM departments, including the Grants and Contracts Office, The Committee on Financial Conflicts of Interest in Research, the Office for Research Administrative Compliance, the School Compliance office, the Radiation Safety Committee, the Biosafety Committee, the Privacy Officer and the Dean for Research, the Legal department, the Research Integrity Officer, and the Office of Risk Management. + Coordinate Mount Sinai’s research affiliate relationships including the Queens Hospital Center, Elmhurst Hospital Center, Bronx Veteran’s Affair Center, including facilitation of expeditious transmission of IRB reviews and approvals, standardization of policies and procedures across sites where possible to prevent cross-committee contradiction or omission of significant review elements, negotiation of inter-institutional agreements in order to prevent duplication of effort. + Correspond with representatives of the Office for Human Subjects Protection (OHRP), the Food and Drug Administration (FDA), the Office for Research Compliance, representatives of AAHRPP and any external governmental or private agency as necessary, and maintain correspondence documentation. + Coordinate site visits/inspections as necessary + Liaison with the Legal Department on human research regulatory issues + **Other responsibilities:** + ESCRO Program/Committee oversight and management + Genomic Data Sharing Program oversight and management + Certificate of Confidentiality document management + Maintain the IRB website as a primary information source for members of the MSSM research community. + Handle special projects/investigations as requested. **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** **Compensation Statement** Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $78884 - $143500 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.