Rutgers, The State University of New Jersey is seeking a Clinical Research Coordinator III (CRCIII) for the Department of Medicine-Infectious Diseases within the New Jersey Medical School. The Clinical Research Coordinator III will serve as a member of the Clinical Research team. This position is responsible for coordinating and supporting the regulatory affairs activities encountered in clinical research trials conducted by the Clinical Research Center. This includes preparation of Institutional Review Board (IRB) applications, responses to funding agencies, regulatory bodies and pharmaceutical partners, & preparing investigator documentation. The CRCIII will assist the Clinical Research Team by ensuring adherence to protocols, appropriate regulations, and present and future deadlines.
Among the key duties of this position are the following:
Assist with all regulatory activities for the Clinical Research Center and support the team by establishing priorities for workflow within the Department. The CRCIII provides support and oversight to others in the conduct of regulatory activities.
Review research proposals/protocols under which human subjects may be involved for conformity to University policy and Institutional Review Board requirements and federal regulations.
Coordinate the protocol approval process with Committees.
Compose and submit Investigational new Drug Applications to the FDA for drugs needing FDA approval.
Ensures necessary documentation, i.e., licenses, CVs, 1572, Lab values, CLIA, CAP, and IRB rosters, as well as other required regulatory documents required are on file prior to initiation of any protocol.
Minimum Education and Experience:
Bachelor's Degree in a related field.
Equivalent education, experience, and/or training may be substituted for the degree requirements.
CRCIII will be trained on Regulatory Requirements, & Good Clinical Practices (GCP).
Able to function independently and work flexible hours including weekends and evenings.
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.