Mount Sinai Careers

Clinical Trials Quality Assurance Manager, Tisch Cancer Institute

New York, New York
Research


Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 

Tisch Cancer Institute, Clinical Trials Quality Assurance Manager 2335298

 
Roles & Responsibilities:

For quality assurance review performed on all therapeutic clinical trials conducted at the Tisch Cancer Institute (IIT; Cooperative; Industry Sponsored), the Clinical Trials QA Manager is responsible for data management and system procedures, quality of data collection and protocol adherence.

 

Duties and Responsibilities:

  • Responsible for on-site clinical trials data quality review and audits of Phase I, II, and III clinical trials
  • Responsible for on-site clinical trials data quality review and audits of Phase I, II, and III clinical trials
  • Responsible for preparing Internal Audit Policy & Reports in collaboration with the MSMC’s Research Compliance/QA department
  • Responsible for induction and training/continuing education of new and existing employees. Develops training materials, presentations and applicable tests and guides for Cancer Institute staff and faculty
  • Coordinates, conducts, tracks and resolves MSMC corrective and preventative action (CAPA) investigations. Reviews and verifies corrective actions of cited observations
  • Assists Data Safety and Monitoring Board with meeting documents, minutes and reviews
  • Assists Clinical Trials leadership with FDA, NIH and Sponsor Audits
  • Other special projects as deemed necessary
 
 
Requirements:
  • BA/BS in Life Sciences or RN/BSN in Nursing
  • 2-5 years experience managing clinical trials. Hands on experience of GCP auditing or data monitoring preferred
  • In-depth understanding of GCP guidelines from ICH and NCI
  • Management/leadership experience
  • Research quality assurance experience in Phase I to Phase IV clinical trials preferred
  • Excellent organizational skills and decision making authority require
  • Demonstrated knowledge of clinical research concepts, and regulatory compliance
  • Basic electronic data capture experience
 
 
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. 

 

EOE Minorities/Women/Disabled/Veterans


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