Rutgers, The State University of New Jersey, is seeking a motivated Clinical Research Coordinator, for the Rutgers Institute for Translational Medicine and Science (RITMS) within the Clinical Trails Office (CTO).
The CTO Clinical Research Coordinator will serve as the entry point person for investigators when they access CTO through portals, e-mails, or call requests for support for investigator initiated, cooperative group, network or industry sponsored studies.
Among the key duties of this position are the following:
Serves as the entry point person for investigators when they access CTO.
Performs comprehensive written feasibility assessment for each study in collaboration with the investigator, program manager and recruitment specialists and the CRUs.
Works with the Clinical Trials Specialist (Regulatory Specialist) with protocol submissions to the SRB in collaboration with the investigators.
Provides support to the SRB (setting up agendas, scheduling meetings, communication with investigators, taking and circulating meeting minutes).
Works with Clinical Trials Specialist (Regulatory Specialist) in providing guidance to investigators regarding IRB submission process and regulatory submissions for INDs and HUDs.
Determines the presence of competing trials on the same campus and the adequacy of PI's proposed algorithm to handle the competing trials.
Determines the PI's capacity to conduct the trial (i.e. staff bandwidth and experience).
Determines if there are equipment or other resource needs which cannot be accommodated by the school or partner hospital.
Assists with tracking study launch metrics and developing interventions to improve metrics as needed.
Tracks study progress through IRB approval, budgeting and contracting process completion and until study activation.
Minimum Education and Experience:
Bachelor’s degree in a relevant science or related field.
Required Knowledge, Skills, and Abilities:
Strong research specific knowledge base.
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, PowerPoint and REDCAP.
Working knowledge of Clinical Trial Management Systems.
The candidate should have a clear understanding of Food & Drug Administration (FDA), Office of Human Research Protection (OHRP), and Health Insurance Portability & Accountability Act (HIPPA) regulations and possess a considerable understanding of Good Clinical Practice (GCP) guidelines.
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP).
Experience in Clinical research.
Physical Demands and Work Environment:
Lifting up to 25 lbs.
Posting Number: 20ST0901
Location: Downtown New Brunswick
Internal Number: 114829
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.