Rutgers, the State University of New Jersey is seeking a motivated Clinical Trials Office Resource Specialist for the Clinical Trials Office (CTO) within the Rutgers Institute of Translational Medicine and Science. The Clinical Trials Resource Specialist under the direct supervision of the Director, Clinical Trials, will serve as the point person who will work with investigators and Clinical Trials Navigators to evaluate and monitor participant recruitment in studies being managed through TARO. These activities include, but may not be limited to recruitment feasibility assessment, preparation of individual recruitment plan for each study, maintaining TARO recruitment metrics and developing interventions to improve metrics. The Resource Specialist will assist the Manager in developing and maintaining Standard Operating Procedures (SOPs) to ensure the development of comprehensive recruitment assessments plans for each study and ongoing recruitment monitoring of each study until the study close out. The Recruitment specialists will also interact and liaise with the NCATS Recruitment Innovation center (RIC).
Among the key duties of this position are the following:
Develops a written tailored recruitment plan for each study through multiple methods including but not limited ICD code based EMR searches, AI based technology solutions such as DEEP6, web based and social media resources, Clinical Research Data Warehouse, Research Match, New Jersey HIEs and collaboration with community based organizations and special populations.
Works with the investigators to make sure that any study conducted at Rutgers has the greatest chances of success by ensuring resources, clinical and hospital facility access, sound scientific rationale, are included to, improve the start-up time and success of studies.
Reviews research proposals/protocols under which human subjects may be involved for conformity to University policy and Institutional Review Board requirements and federal regulations.
Interacts with data specialist in NJ ACTS Informatics Core (Core B) to conduct the IT-based preparatory research searches to determine availability of sufficient patient population meeting the inclusion and exclusion criterion of the particular study.
Connects investigators to recruitment related resources including referral to NJ ACTS Community Engagement Core (Core C1) and NJ ACTS Integrating Special Populations Core (Core F1).
Maintains continuous study recruitment rate metrics from the start to the end of study.
Conducts regular meetings with investigators and CRU or other clinical research staff to discuss recruitment metrics and any identified barriers.
Develops interventions to improve study recruitment metrics as needed. Also responsible for the accrual reports and warning notices to PI's and study coordinators.
Provides regular reports to TARO leadership regarding progress of recruitment in studies going through TARO.
Minimum Education and Experience:
Bachelor’s degree in a relevant science or related field.
Two years experience in Clinical research related experience, strong research specific knowledge base is required.
Required Knowledge, Skills, and Abilities:
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, PowerPoint, REDCAP.
Working knowledge of Clinical Trial Management Systems.
Detail oriented, excellent organizational, communication and interpersonal skills, self-accountable to high standards of professional excellence, able to maximize resources and be resourceful, seeks and accepts personal and professional responsibility on a continued basis.
Clear understanding of Food & Drug Administration (FDA), Office of Human Research Protection (OHRP), and Health Insurance Portability & Accountability Act (HIPPA) regulations and possess a considerable understanding of Good Clinical Practice (GCP) guidelines. Must be capable of independent decision-making, and multitasking.
Master's degree preferred.
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) preferred.
Physical Demands and Work Environment:
Lifting up to 25 lbs.
Salary: Maximum authorized hiring amount - $77,454
Posting Number: 19ST4934
Location: Downtown New Brunswick
Internal Number: 106685
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.