Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Dept: Tisch Cancer Center REQ # 2451906
Job Title: Regulatory Compliance Coorindator I
The Tisch Cancer Institute is a vital component of the Mount Sinai Health System, which is one of the largest health care systems in the nation. We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer. We have recently established the Center for Computational Immunology to translate new computational approaches to understanding tumors, the immune system, their interaction and co-evolution into improving responses to cancer immunotherapies and the design of next generation therapies. The Regulatory Compliance Coordinator will work with investigators to develop, manage, and maintain public and private datasets primarily related to cancer immunology. The individual will be expected to manage the transfer of data between external parties and TCI, maintain the control of access between parties, and establish protocols around dataset organization.
Roles & Responsibilities:
The position will report into the Manager of Regulatory and will provide support in managing cancer clinical trials for the Center for Thoracic Oncology 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.
Individual should be comfortable with working in
a team environment and will be expected to work collaboratively with
investigators and administration. Datasets will be from industry-sponsored
studies, consortia, NCI projects, and investigator-initiated studies.
1. Provides regulatory support to clinical trial project teams.
2. Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines
3. Develops and/or revises regulatory policies and procedures.
4. Submits application in a timely manner; responds to comments, questions and requests for clarification by IRB review by stated guidelines
5. Participates in Study Initiation Visits and Interim Monitoring Visits
6. Ensures proper regulatory compliance in accordance with sponsoring agency requirements
7. Maintains study specific regulatory binder
8. 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. Working knowledge Good Clinical Practice guidelines and Federal research regulations. Oncology experience preferred
Strength Through Diversity
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!
Who We Are
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.