Mount Sinai Careers
REGULATORY COMPLIANCE COORDINATOR- The Department of Tisch Cancer Institute
Ground breaking science. Advancing medicine. Healing made personal.
Regulatory Compliance Coordinator - #2291388
Roles & Responsibilities:
A Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Institute. The position will report into the Manager of Regulatory and will provide support in managing cancer clinical trials for the division. The Regulatory Compliance Coordinator will is be responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure.
- Provides regulatory support to clinical trial project teams
- Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines
- Develops and/or revises regulatory policies and procedures
- Submits application in a timely manner; responds to comments, questions and requests for clarification by IRB review by stated guidelines
- Participates in Study Initiation Visits and Interim Monitoring Visits
- Ensures proper regulatory compliance in accordance with sponsoring agency requirements
- Maintains study specific regulatory binder
- Performs other duties as assigned
- Bachelor’s Degree preferably in science
- A minimum of 3 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
- Exposure to clinical research in an academic setting
- Excellent written and oral communication skills
- Analytical skills for problem solving; attention to detail and accuracy
- Ability to manage multiple tasks & priorities
- Working knowledge Good Clinical Practice guidelines and Federal research regulations
- Demonstrate strong organizational and communication skills
- Oncology experience preferred
The Mount Sinai Health System
believes that diversity is a driver for excellence. We share a common devotion
to delivering exceptional patient care. Yet we’re as diverse as the city we
call home- culturally, ethically, in outlook and lifestyle. 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 work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
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.