Rutgers, The State University of New Jersey is seeking a Quality Assurance Specialist for the Office of Human Research Services within the Rutgers Cancer Institute of New Jersey.
The primary purpose of the Quality Assurance Specialist position is to conduct quality assurance audits of 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. The specialist will review and analyze documents, monitor research and administrative activities, and provide education to Investigators and research staff.
The specialist will assist 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. The specialist will also facilitate initial and ongoing research educational seminars, workshops, etc. for Cancer Institute of New Jersey research personnel, Investigators, faculty, staff and students.
Among the key duties of this position are the following:
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.
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 of New Jersey Data and Safety Monitoring Plans(s).
Assists with implementing the quality assurance and data monitoring activities for clinical research conducted by RCINJ 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 FDAIND 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, 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.
Hands-on experience in auditing activities in a government and/or pharmaceutical industry setting.
Equivalent education, experience and/or training may be substituted for the degree requirement.
Required Knowledge, Skills, and Abilities:
Working knowledge of United States Federal regulations and Medical Device regulations.
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.
Experience should include: conducting audits at clinical trial sites, relevant education and qualification in Science, Medical or Pharmacology disciplines.
Posting Number: 21ST0980
Location: Downtown New Brunswick
Internal Number: 130466
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.