Rutgers, The State University of New Jersey is seeking a Clinical Contracts Manager for our Clinical Trials Office. A goal of the 2014 RBHS Strategic Plan was to significantly expand clinical and translational research across RBHS. 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 RBHS 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 CRC/CRUs, specialized facilities for clinical trials, and monitoring of studies. RBHS has created a Clinical Trials Office (CTO), under the direction of the Vice Chancellor for Translational Medicine and Science, to centralize all clinical trial related administrative, managerial, financial, and regulatory (not IRB) requirements in a 'one-stop shop.' It also has centralized functions required by the Clinical and Translational Science Award (CTSA) to streamline and facilitate trial initiation, implement CTSA-wide studies, and monitor study accrual with those currently managed by Office of Research and Economic Development (ORED) for contract negotiations and Grant and Contract Accounting (GCA) for clinical trial invoicing and reconciliation. These latter responsibilities have been moved from ORED to the CTO. The CTO Clinical 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 Rutgers and its faculty. The CTO Clinical 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.
Minimum Education and Experience:
Bachelor’s of Arts or Bachelor’s of Science degree. Three to five years of clinical trial agreement management, review, and negotiation experience are required, with at least two (2) years contract management experience in i academic medical research institution environment.
Required Knowledge, Skills, and Abilities:
*Clear experience of negotiating both industry-sponsored and non-industry sponsored clinical trials *Extensive background in associated regulations governing clinical research *Strong understanding of policy and practice governing clinical research within a large institution
Strong communication skills (verbal and written)
Ability to communicate complex information in English effectively both verbally and written to all levels of staff, management and external partners
Ability to work well with all levels of staff both within an organization, across functions, and across cultures; demonstrated ability to work effectively in cultures and environments other than one's own
Ability to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner
Self-motivated, detail-oriented and capable of handling significant responsibility, as well as, shifting priorities; exercises discretion; takes initiative to resolve problems
Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required
Must have a passion for excellent customer service and commitment
Major in Paralegal Studies, Law, and/or Juris Doctor desired.
Posting Number: 19ST5072
Location: Downtown New Brunswick
Internal Number: 107615
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.