Senior Quality Monitoring Coordinator, Clinical Trials - Population Health Science & Policy

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

 
Roles & Responsibilities:
The Quality Monitoring Coordinator supports the departmental and field activities for the conduct of clinical research studies in compliance with applicable regulatory standards, IRB policies and procedures and internal requirements. He/she will work collaboratively with the clinical trial Coordinators, Project Managers, Quality Assurance Coordinators and others. He/she will report directly to the Clinical Trial Monitoring Manager.

Under the supervision of the Clinical Trial Monitoring Manager, will conduct monitoring tasks such as source verification of eligibility criteria, informed consent, or other specified study assessments.

  • Ensures compliance with good clinical practice and regulatory guidelines by monitoring accurate, complete and timely data submission by clinical investigators via remote and in-person visits. Implements corrective action as necessary.
  • Evaluates research data, protocol compliance and research file organization for clinical trials. Responsible for site monitoring, including review of source documentation, case report forms, electronic dates of entry and data reports for accuracy and timely submissions
  • Will request and review source documentation related to protocol defined data collection from clinical sites. Will track source received and source monitored via the Electronic Data Capture System.
  • Communicates results from contact reports and monitoring visits to appropriate staff.
  • Assures adequate reporting of adverse events, deviations from protocols and patient status.
  • Identifies areas requiring follow-up and improvement at each clinical study site. Recommends corrective action. Follows up on action items to ensure completion.
  • Under the supervision of the Clinical Trial Monitoring Manager, will draft correspondence as needed to support monitoring related communications to clinical sites, including follow up to outstanding items from previous visits.
  • Provide logistical support for monitoring visits including scheduling and document preparation as needed.
  • Ensures that all study documentation is properly maintained.
  • Participate in regular teleconferences, staff meetings, etc.
  • Other duties as assigned.

Requirements:

  • Bachelor's degree; Master's degree preferred
  • Strong interpersonal communication skills, both written and verbal. 
  • Attention to detail and strong organizational skills are required. 
  • Ability to multi-task and thrive in a dynamic fast-paced environment. 
  • Ability to work independently within the scope of a team environment. Experience working in an academic environment with a concentration in Health Policy, Public Health, and Community Research preferred. required, 
  • Proficiency in MS Office software is highly desirable. Two years of clinical research 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. 

EOE Minorities/Women/Disabled/Veterans

 

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