Mount Sinai Careers
Assistant Director, Regulatory Affairs, Tisch Cancer Institute
Ground breaking science. Advancing medicine. Healing made personal.
Tisch Cancer Institute, Assistant Director, Regulatory Affairs 2334450
The Assistant Director Regulatory Affairs in the CCTO is critical position reporting directly to the Executive Director of Clinical Research Administration and will provide oversight and assist in the supervision and direction of the activities of Regulatory. Responsible for the development and updating of relevant Standard Operating Procedures. Serves as an expert on specified regulatory compliance issues; prepares regulatory reports to Senior Leadership in TCI. Recruits, hires, trains and supervises Regulatory staff in the CCTO including Multi – Center Operations.
- Provide oversight to regulatory group to ensure compliance with GCP, IRB, FDA and other regulatory agencies
- Liaises with sponsors, investigators and disease team members, providing trial information and updates as required in written, oral, and meeting format, adhering to appropriate timelines
- Oversee the timely submissions of all reviews and maintenance of research protocols submitted to IRB and other review committees and regulatory agencies
- Develop and implement metrics for reporting to Senior Leadership in the TCI for productivity and quality
- Hire, supervise, coach, mentor and manage performance of Regulatory staff and Multi-Center Operations
- Provide oversight of regulatory compliance and monitoring
- Performs any other tasks that are assigned by Senior Leadership to help the organization meet its mission
- Bachelor's degree in health, science, public or business administration or a related field or equivalent education and experience; Masters (MPA, MPH, MBA or related) is preferred
- Knowledge of clinical research trials regulations and accreditation agencies (JCAHO, NYSDOH etc.)
- 4-7 years of research experience with health related, or project management experience required
- Excellent oral and written communication skills
- Demonstrate hands-on experience win cancer related clinical trials regulatory operations
- Prior Supervisory experience required
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Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.