Position Summary:

• Provides support for the development of center initiatives in quality assurance and data monitoring to foster current and future clinical research services that facilitate the mission and contribute to achieving the RCI's overall quality research objectives.
• Assists with coordination of all activities of the Quality Assurance and Data Monitoring Division of the Office of Human Research Services.
• Supports the implementation of priorities within appropriate time lines for the conduct of quality assurance audits that meet the standards and requirements described in the Rutgers Cancer Institute Data and Safety Monitoring Plans(s).
• Assists with implementing the quality assurance and data monitoring activities for clinical research conducted by RCI to meet defined objectives.
• Assists the Manager, Quality Assurance and Data Monitoring, with implementing a system for the Quality Assurance and Data Monitoring Division to provide continuous administrative support to the Human Research Oversight Committee (HROC). This includes gathering data for the Chair of HROC, development/dissemination of meeting minutes, creation/distribution of HROC action memos, generating FDA IND annual reports as applicable and quarterly summary reporting to the External Data Safety Monitoring Committee.

Minimum Education and Experience:

• Bachelor's Degree in related field (Master's Degree preferred), plus a minimum of three (3) years experience in oncology clinical trials research in an academic, pharmaceutical or governmental setting required, of which a minimum of one (1) year should have been in quality assurance and data monitoring.
• Experience should include: conducting audits at clinical trial sites, relevant education and qualification in Science, Medical or Pharmacology disciplines.
• Hands-on experience in auditing activities in a government and/or pharmaceutical industry setting.
• Working knowledge of United States Federal regulations and Medical Device regulations is required.
• Equivalent education, experience and/or training may be substituted for the degree requirement.

City: New Brunswick

State: NJ

Physical Demands and Work Environment:

• Standing, sitting, walking, talking and hearing. 
• No special vision requirements. 
• Lifting up to 25 lbs. 

• Office environment. Moderate noise.

Posting Number: 26ST0860

About Rutgers University

Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.

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