Job Description
Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Roles & Responsibilities:
The Regulatory Coordinator helps manage the regulatory activities and functions of the Clinical Trials Division of the Addiction Institute of Mount Sinai (AIMS) to ensure that goals and objectives specified for the program are accomplished in accordance with established regulatory policies and procedures. The Regulatory Coordinator will provide a broad range of regulatory services for new and ongoing projects including:
Responsibilities
•Assists with the development of new IRB submissions with research staff and oversees IRB amendments and renewals.
•Helps to maintain regulatory documentation and compliances with polices of NIH, DEA, FDA regulations.
•Prepares and responds to monitoring visits by internal and external monitors.
•Works with research associates in the resolution of all regulatory related issues and assists in resolving complex processing problems.
•Maintains awareness of study regulatory status and works with research staff to ensure regulatory documents are up to date and on file.
•Monitors any potential outward effects or issues regarding patient/research participant safety and reports to the Principal Investigators.
•Responds to requests for Program project regulatory information, summaries, and data based on information compiled from various sources.
•Prepares and review regulatory documents independently and generates status/progress reports for ongoing and pending program related projects.
•Plans, outlines and drafts regulatory agendas, and reports.
•Onboards, trains, and manages regulatory workflow of junior research support staff (e.g., Research Coordinators, Research Assistants/Volunteers).
Qualifications

• Bachelor degree preferred, or equivalent combination of education and applicable experience (preferred: research or regulatory)
• 3 years of experience in clinical research or a related field
• Experience working with sponsors, FDA and consortiums preferred.

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.

We work hard to acquire and retain the best people and to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to professional advance. We share the belief that all employees, regardless of job title or expertise contribute to the patient experience and quality of patient care.

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