Rutgers, the State University of New Jersey is seeing a Regulatory Affairs Manager for the Office of Human Research Services at Rutgers Cancer Institute of New Jersey (CINJ).
The primary purpose of the Manager, Regulatory Affairs serves as the communications lead for regulatory affairs to support all Scientific Review, Biosafety Review, and FDA submission activities at the Rutgers Cancer Institute of New Jersey. This individual is responsible for planning, directing and monitoring the daily work of all staff supporting the Scientific Review Board. The scope of work includes management of all Protocol Review and Monitoring System activities, monitoring compliance with Clinicaltrials.gov requirements, submission and maintenance of all Investigational New Drug (IND) applications, and submission of Institutional Biosafety Committee (IBC) application. Assures that all clinical research conducted within the Cancer Institute is according to Good Clinical Practice (GCP) guidelines as well as applicable Institutional, State and Federal regulations and guidelines. Assists the Research Study Manager, Regulatory Affairs in ensuring adherence to protocols, regulations, and deadlines.
Among the key duties of this position are the following:
Serves as regulatory liaison for interdepartmental and external agencies including, but not limited to Scientific Review Board (SRB), Human Research Oversight Committee (HROC), Institutional Biosafety Committee (IBC), Rutgers Biomedical Health Sciences (RBHS) IRB, Office of Human Research Protection (OHRP) and Food and Drug Administration (FDA).
Manages and actively supports the Investigational New Drug filings (including New INDs, amendments, exemptions, deviations, an annual and safety reports), and all related regulatory filings.
In collaboration with the Manager, Quality Assurance supports the planning, preparation and execution of all monitoring and auditing activities related to INDs and/or clinical trials under their auspice.
Cultivates and maintains effective working relationship with the Rutgers Biological Safety Community.
Tracks timelines of protocols from SRB to IRB approval and patient enrollment on study identifying and implementing quality improvement processes to minimize delays in approvals.
Performs regulatory review of study documents (i.e., protocol, informed consent forms, etc.) during protocol development.
Minimum Education and Experience:
Bachelor's Degree in related science in a 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 a leadership role in protocol review and monitoring or regulatory affairs.
Experience with growing clinical and research programs is essential as are demonstrated collaborative skills at multiple levels.
Equivalent experience, education and/or training may be substituted for educational requirements.
Required Knowledge, Skills, and Abilities:
Working knowledge of regulatory requirements.
Strong, creative, entrepreneurial management and interpersonal leadership skills.
Demonstrated knowledge is necessary of how to accomplish superior performance in a unionized environment.
Effective oral and communication skills.
Computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Posting Number: 20ST1819
Location: Downtown New Brunswick
Internal Number: 120831
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.