Rutgers, The State University of New Jersey is seeking a Clinical Research Contract Manager for the Office of Human Research Services at Rutgers Cancer Institute of New Jersey.
The Rutgers Cancer Institute of New Jersey must continue to drive clinical and translational research in oncology. While the continuum of research in clinical and translational science is broad, a critical and highly regulated sector of that research are clinical trials.
Clinical trials, funded by pharmaceutical/device/biologics companies and the federal government, are regulated by the FDA, OHRP, ICH, etc. A key element in the success of a trial is the successful recruitment and retention of patients as participants in the studies. This requires well phenotyped patients with the condition being studied, efficient processes for ensuring that CINJ undertake only those studies for which there are sufficient potential participants, timely negotiation of budgets and contracts, coordination across the clinical enterprise and with the OHRS, specialized facilities for clinical trials, and monitoring of studies.
The CINJ Office of Human Research Services is the office in which the cancer center centralizes all human trial related administrative, managerial, financial, and regulatory (not IRB) requirements in a 'one-stop shop.' It also has centralized functions required by the NCI Cancer Center Support Grant to streamline and facilitate trial initiation, implement system-wide studies, and monitor study accrual.
The Clinical Research Contracts Manager's purpose is to foster mutually beneficial strategic alliances between Rutgers University and clinical research industry sponsors, to benefit of the sponsors, New Jersey, and the general public through professional and responsive review, negotiation, and management of clinical trials and associated clinical research agreements, on behalf of CINJ and its faculty. The Clinical Research Contracts Manager will be responsible for independently reviewing, interpreting and negotiating clinical trials, nondisclosure agreements, and associated agreements from a legal, business, and technical perspective.
Among the key duties of this position are the following:
Expertly reviews and approves clinical trial and related agreements in accordance with applicable regulations and academic requirements. Displays leadership by providing timely and effective guidance on negotiation strategies and industry
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.