Rutgers, The State University of New Jersey, is seeking a Clinical Trials Specialist, Rapid Activation for the Office of Human Research Services at the Cancer Institute of New Jersey. The primary purpose of the Clinical Trials Specialist, Rapid Activation is to manage the start-up activities of highly priority clinical trials proposed to and/or entering into the OHRS clinical research program portfolio. In addition, this position is responsible for maintaining relationships and facilitating progress across multiple disease specific groups (DSGs). Among the key duties of this position are the following:
Serves as the primary responsible party and point of contact during clinical research trial feasibility, planning, and implementation up until the point of site activation.
Collaborates with Disease Specific Group Leaders and Principal Investigators on assessment and implementation of highly complex trials for OHRS as assigned, including but not limited to, identifying accrual targets, study activation timelines and metrics and resolving potential discrepancies and/or barriers to timely study activation.
Collaborates with investigators, research staff, finance, hospital departments, and study sponsors with developing, implementing and evaluating clinical research protocols while utilizing knowledge of clinical research principles and regulations.
Ensures clinical research processes are patient centered and actively contributes to create a friendly, welcoming and safe environment for CINJ customers.
Communicates with Investigators in a professional manner and provides updates to Investigators the status of study activation timelines.
Acts as a liaison with Study Sponsors visiting the Cancer Center to evaluate feasibility.
Provides orientation of new staff to the study activation process within the department.
Ensures that research protocols are approved by the Institutional Review Board and all regulatory documentation is completed prior to the initiation of protocol in OHRS.
Maintains departmental files per record retention policy.
Tracks all study activation metrics and provides monthly reports to management.
Minimum Education and Experience:
Bachelor's Degree in a social science or related field.
Required Knowledge, Skills, and Abilities:
The ideal candidate will be detail oriented, have excellent organizational skills, be proficient in computer applications and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and Oncore™, possess excellent communication and interpersonal skills, be able to maximize resources and be resourceful.
Minimum of one (1) to three (3) years of oncology experience.
Previous experience as a clinical research coordinator/research nurse.
Bilingual skills (English/Spanish).
Physical Demands and Work Environment:
Physical Demands: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25 lbs.
Work Environment: Office environment. Moderate noise.
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.