Rutgers, The State University of New Jersey, is seeking a Quality Specialist for the Operations department for Rutgers Cancer Institute of New Jersey. The primary purpose of the Quality Specialist position is to conduct quality assurance audits of all phase I research protocols and research operations to ensure compliance with FDA, GCP, ICH guidelines and Rutgers Cancer Institute of New Jersey standard operating procedures (SOPS) and guidelines.
Among the key duties of this position are the following:
Assists the Manager, Quality Assurance and Data Monitoring, in the organization and development of a quality assurance infrastructure to include assisting in the implementation of research specific quality assurance activities in collaboration with other staff and leadership of the Office of Human Research Services as necessary.
Reviews and analyzes documents, monitors research and administrative activities, and provides education to Investigators and research staff.
Assists in the preparation of reports on audit findings and make recommendations for corrective actions to ensure resolution of and deviations from SOPs, protocols, and GCP and ICH guidelines.
Facilitates initial and ongoing research educational seminars, workshops, etc. for Cancer Institute of New Jersey research personnel, Investigators, faculty, staff and students.
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 RCINJ’s overall quality research objectives.
Supports the implementation of priorities within appropriate time lines for the conduct of quality assurance audits that meetthe standards and requirements described in the Rutgers Cancer Institute of New Jersey Data and Safety Monitoring Plans(s).
Minimum Education and Experience:
Bachelor’s Degree in related field.
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.
Equivalent education, experience and/or training may be substituted for the degree requirement.
Required Knowledge, Skills, and Abilities:
Experience 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.
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access and PowerPoint.
Demonstrated ability to be focused on customer service and results, to be flexible, self-motivated and to set priorities.
Outstanding human relations skills and the ability to function in a team environment.
Physical Demands and Work Environment:
PHYSICALDEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.
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.