Rutgers, The State University of New Jersey, is seeking a Program Development Analyst, for the Office of Human Research Services (OHRS) at the Rutgers Cancer Institute of New Jersey.
The primary purpose of the Program Development Analyst position is to manage the National Clinical Trials Network (NCTN) regulatory activities of the Rutgers Cancer Institute of New Jersey. These activities include, but may not be limited to preparation of documents for submission to the Institutional Review Board, followup on all NCTN correspondence, and maintenance of regulatory documents at all performance sites. In addition, the Program Assistant will assist in the coordination of the Cancer Trials Support Unit (CTSU) activities for the Cancer Center.
Among the key duties of this position are the following:
Communicates effectively with Cancer Center/Statewide investigators, Statewide research staff, CTSU, and monitoring personnel from the NCTN. Responds to routine questions related to regulatory matters and refers more complex questions to others as appropriate.
Tracks amendments and annual reviews of NCI cIRB approval documents through CTSU website.
Manages the study closure process of NCTN protocols.
Collects and tracks all regulatory documentation (site NCI cIRB approvals, informed consent forms, CITI certificates, Form FDA 1572s, Curriculum Vitae, medical licenses, lab norms, etc.) from our network sites for all NCTN trials.
Minimum Education and Experience:
Bachelor’s Degree plus (3) years experience in clinical research regulatory affairs.
Equivalent experience, education and/or training may be substituted for the education requirements.
Required Knowledge, Skills, and Abilities:
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access PowerPoint and Oncore.
The ideal candidate will have a clear understanding of Food & Drug Administration (FDA), Office of Human Research Protections (OHRP), National Institutes of Health (NIH) and Health Insurance Portability & Accountability Act (HIPPA) regulations, possess a considerable understanding of Good Clinical Practice (GCP) guidelines, institutional guidelines and SOP’s set forth by CINJ and Rutgers.
Must be capable of independent decision-making, and multitasking.
Must have excellent organization, communication and interpersonal skills, hold him/herself accountable to high standards of professional excellence, be able to maximize resources, and seek and accept personal and professional responsibility.
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) certification.
Clinical research project administration experience in the pharmaceutical industry is also highly desirable.
Posting Number: 20ST0073
Location: Downtown New Brunswick
Internal Number: 108964
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.