Clinical Trials Quality Assurance Manager - Tisch Cancer Institute

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 

Clinical Trials Quality Assurance Manager – Tisch Cancer Institute, 2421212

 

The Clinical Trials Quality Assurance Manager will ensure quality assurance review is performed on all therapeutic clinical trials conducted at the Tisch Cancer Institute (IIT; Cooperative; Industry Sponsored). Duties will include activities such as data management and system procedures, quality of data collection and protocol adherence.

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:

  • 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:
  • Education: BA/BS in Life Sciences, or RN/BSN in Nursing.
  • Experience: 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 required
  • Demonstrated knowledge of clinical research concepts, and regulatory compliance.
  • Microsoft Word/PowerPoint/Excel/Intermediate Outlook; Basic electronic data capture experience. 
 

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. 

 

EOE Minorities/Women/Disabled/Veterans


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