Regional Campus: Rutgers Biomedical and Health Sciences (RBHS)
Posting Number: 17ST1387
Job Type: Full Time
Rutgers, The State University of New Jersey, is seeking a Program Development Analyst (Regulatory Affairs) for the Office of Human Research Services (OHRS) department at the Rutgers Cancer Institute of New Jersey. The Program Development Analyst will manage the regulatory activities of the Office of Human Research Services (OHRS). Among the key duties of this position are the following:
Preparation of documents for submission to the Institutional Review Board (IRB), Investigational New Drug (IND) preparation and maintenance, submissions of letters of intent and protocols to be submitted to the National Cancer Institute or pharmaceutical sponsors.
Manage and maintain regulatory documents for Cancer Institute of New Jersey investigator-initiated, national cooperative group and industry trials.
Assist in developing and maintaining Standard Operating Procedures (SOPs) that comply with all pertinent regulations to ensure the accuracy and timely of all protocols, consent forms, amendments, annual re-approvals, serious adverse events, and IND safety reports to the IRB.
Home Location Campus: Downtown New Brunswick
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) certification preferred.
Clinical research project administration experience in the pharmaceutical industry is also highly desirable.
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.
To be successful, the candidate 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.
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.