Rutgers, The State University of New Jersey, is seeking a Research Study Manager, Regulatory Affairs, for the Office of Human Research Services at the Rutgers Cancer Institute of New Jersey.
The primary purpose of the Research Study Manager, Regulatory Affairs position is to plan, direct and monitor the daily work of all staff for the Regulatory Affairs Office within the Office of Human Research Services (OHRS).
Among the key duties of this position are the following:
Responsible for the supervision of day-to-day clinical research operations as they relate to the Regulatory Affairs Office.
Serves as regulatory liaison for interdepartmental and external agencies including, but not limited to Scientific Review Board (SRB), Human Research Oversight Committee (HROC), Rutgers Biomedical Health Sciences (RBHS) IRB, Office of Human Research Protection (OHRP) and Food and Drug Administration (FDA).
Provides human subjects protection knowledge and expertise to help facilitate ethical review and ensure regulatory compliance within the Center and at participating CINJOG/multi-center sites.
Performs regulatory review of study documents (i.e., protocol, informed consent forms, etc.) during protocol development.
Develops a system for the Regulatory Affairs Office to provide continuous administrative support to the SRB. This includes generation and distribution of materials prior to each SRB meeting as well as collection and collation of reviewer comments for the development of meeting minutes and dissemination of review and outcomes to Investigators.
Works closely with Management team in developing, implementing and evaluating standard operating procedures to support the regulatory affairs activities of the Center.
Manages the regulatory tracking and archive systems in Oncore®.
Minimum Education and Experience:
Bachelor's Degree in related field.
Five (5) years of relevant experience.
Three (3) years of oncology research experience in an academic, pharmaceutical or governmental setting with experience in conducting GCP audits at trial sites.
One (1) to two (2) years of supervisory experience in a clinical research environment.
Equivalent education, experience and/or training may be substituted for the degree requirements.
Required Knowledge, Skills, and Abilities:
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) certification required within (1) year of hire.
Strong knowledge of United States Federal regulations and Medical Device regulations.
Effective oral and written communication skills.
Proficiency with database and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and Oncore®.
At least one (1) year of supervisory experience in a unionized environment.
Physical Demands and Work Environment:
PHYSICALDEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25 lbs.
Posting Number: 18ST1422
Location: Downtown New Brunswick
Internal Number: 64926
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.