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 Program Development Analyst, under the direct supervision of the Program Director, will manage the regulatory activities of the Office of Human Research Services (OHRS). Among the key duties of this position are the following:
Prepares documents for submission to the Network Institutional Review Board (IRB) offices, and follows up with correspondence to the IRB with the goal to obtain IRB approval, and manages and maintains regulatory documents for trials conducted in CINJ Oncology Group. (CINJOG)
Manages receipt of patient registration in ONCORE, maintains and coordinates the monthly reporting of CINJOG clinical trial availability and accrual, and submit for compensation to sites for accrual.
Communicates effectively with CINJOG Investigators, Network staff, Cancer Institute of New Jersey staff, industry sponsors, monitoring personnel from the national oncology cooperative groups, Cancer Trials Support Unit (CTSU) of the NCI, Food and Drug Administration (FDA), and others.
Educates CINJOG and Statewide Network staff at participating institution on the electronic systems to obtain IRB approval.
Coordinates the registration process for all electronic IRB systems (Rutgers, NCI, etc.), and the process by which CINJOG protocols are approved.
Manages the CINJOG protocol amendment approval process, CINJOG process regarding annual review and updates, and the study closure process of CINJOG protocols.
Collects and tracks all regulatory documentation (site IRB approvals, informed consent forms, CITI certificates, Rutgers Investigator Financial & Other Personal Interests Disclosure Form, Form FDA 1572s, Curriculum Vitae, medical licenses, lab norms, etc. from all participating investigators and from our partner and affiliate sites for all national cooperative oncology groups for which Cancer Institute of New Jersey is lead institution; and through Cancer Institute of New Jersey Oncology Group network sites that participate in CINJOG assigned studies where Cancer Institute of New Jersey is the coordinating center.
Minimum Education and Experience:
Bachelor's Degree plus (3) years experience in clinical research regulatory affairs.
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.
Equivalent experience, education and/or training may be substituted for the education requirements.
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP), certification.
Clinical research project administration experience in the pharmaceutical industry.
Physical Demands and Work Environment:
Physical Demands: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.
Work Environment: Office environment. Moderate noise.
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.