Rutgers, the State University of New Jersey is seeking a Multicenter Clinical Trial Specialist for the Office of Human Research Services (OHRS) at Rutgers Cancer Institute of New Jersey.
The Clinical Trials Specialist, Multicenter is responsible for providing coordination of multi-center trials including study start-up, regulatory management and monitoring support. Responsibilities include extrapolation, collection, compilation, and data submission review of patient registration, treatment plans, adverse event reporting, clinical response and long term follow-up for all Rutgers Cancer Institute of New Jersey sponsor-investigator clinical research trials. Ensures protocol compliance per Food and Drug Administration (FDA), Good Clinical Practice (GCP) guidelines, Office for Human Research Protection (OHRP), institutional guidelines and standard operating procedures (SOP's) set forth by the Cancer Institute and Rutgers University.
Among the key duties of this position are the following:
Assists Principal Investigator and supervisor with assessing multisite feasibility as well as documents the site selection process.
Facilitates multicenter protocol submissions to the Cancer Institute Scientific Review Board (SRB) through the OnCore electronic Protocol Review and Monitoring System (ePRMS).
Prepares and develops in collaboration with principal investigator a variety of documents including protocols, data capture plans and case report forms (CRFs), informed consent forms, study operations and lab manuals, and other relevant documentation required for the conduct of a multisite clinical trial.
Prepare submission documents to the Institution Review Board (IRB) of record for the study.
Documents include initial application, consent, recruitment materials, pill diaries as required. In collaboration with the Principal Investigator, acts as a liaison with Cancer Institute of New Jersey and IRB to streamline the approval process through the communication and facilitation of the responses to IRB queries.
Minimum Education and Experience:
Bachelor's Degree in a social science or related field.
Previous experience as a clinical research coordinator/research nurse.
Required Knowledge, Skills, and Abilities:
Detail oriented, have excellent organizational skills.
Proficient in computer applications and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and Oncore™.
Excellent communication and interpersonal skills, be able to maximize resources and be resourceful.
Minimum of one (1) to three (3) years of oncology experience.
Posting Number: 20ST1968
Location: Downtown New Brunswick
Internal Number: 121783
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.