Regulatory Compliance Coordinator - Tisch Cancer Institute

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 

Dept-015 Tisch Cancer Institute       REQ #2451328

 

Job Title: Regulatory Compliance Coordinator


Description:

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 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.

 

The Center for Thoracic Oncology has the goal of ensuring best quality care of patients with Lung Cancer and enhance research in the field of Lung Cancer and other thoracic malignancies.  

 

The Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in 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.  

 
Roles & 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 

 

Requirements:

  • 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



Strength Through Diversity

The Mount Sinai Health System believes that diversity and inclusion 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 healthcare delivery together.
 
We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have 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 hospitals, including Mount Sinai Beth Israel, Mount Sinai 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. 

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