Mount Sinai Careers

Regulatory Compliance Coordinator, Tisch Cancer Institute

New York, New York

Job Description

The Mount Sinai Health System
Do you have what it takes to wear the badge?

The Mount Sinai Health System’s commitment to excellence extends beyond delivering world-class health care. The System’s ongoing success is dependent upon our highly motivated, nonclinical professionals working to improve business operations. Our leadership team is driven to provide exceptional service by cultivating a workforce that is dedicated to upholding Mount Sinai’s mission of delivering innovative, breakthrough medicine with compassion and integrity.


Are you ready to discover the world of limitless possibilities that comes with wearing the badge? Explore more about this opportunity and how you can help us write a new chapter in our story of unrivaled patient care!


What You’ll Do:


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.

Duties and Responsibilities:

  • 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

What You’ll Bring:

  • 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

Do you share our dedication to extraordinary service and have what it takes to wear the badge? Apply now!


Who We Are:


Over 35,000 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 committed to the tenets of diversity and workforce that are strengthened by the inclusion of and respect for our differences. We offer our employees a highly competitive compensation and benefits package, a 403(b) retirement plan, and much more.


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.

EOE Minorities/Women/Disabled/Veterans