Rutgers, The State University of New Jersey is seeking a Research Study Assistant in Office of Human Research Services at Rutgers Cancer Institute of New Jersey.
The primary purpose of the Research Study Assistant position is to assist the Cancer Institute of New Jersey's multidisciplinary Oncology Clinical Research Team with collecting data from clinical trials created for pharmaceuticals, biologics, or devices. This position is responsible for ensuring the accuracy of information transcribed from patient medical records onto study specific case report forms or into electronic data capture systems. Ensures protocol compliance per Food and Drug Administration (FDA), National Institutes of Health (NIH), Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, Office for Human Research Protection (OHRP), Health Insurance Portability and Accountability Act (HIPAA), institutional guidelines and standard operating procedures (SOPs) set forth by Rutgers Cancer Institute of New Jersey and Rutgers Biomedical and Health Sciences(RBHS).
Among the key duties of this position are the following:
Works with complex computerized records systems and maintains security and integrity.
In collaboration with the Oncology Clinical Research Coordinator II/III, Research Nurse Clinician (RNC) and/or physician, obtains source documents (i.e. medical record documentation) as needed. Submits x-rays, pathology reports and any other specialized reports as needed.
Maintains research record (e.g. patient consent, eligibility, Case Report Forms(CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in the Cancer Institute of New Jersey clinical trials. This includes, but is not limited to, Cancer Institute of New Jersey Network centers (Cancer Institute of New Jersey investigator-initiated trials), community physicians' offices and hospitals.
Under guidance of his/her directsupervisor or assigned Oncology Research Coordinator II/III, performs abstraction of data from source recordsin human subject charts(i.e., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, Aria, etc.); abstraction of data from publications, or data collection from outside physician offices. According to protocol guidelines records all patient data as required onto study specific Case Report Forms or into designed electronic data capture system.
Uses research databases efficiently to complete assigned tasks. As needed, attends training classes for understanding program.
Enters data into the relevant data collection forms as per established protocol or project timelines. For protocols, this time should not exceed 10 days after each human subject visit.
Completes queries re:to data inconsistencies and revises case report forms in compliance with standard operating procedures.
Using OncoreĀ®, provides regular reports to the Disease Study Group (DSG) members and Principal Investigator on all studies to which he/she is assigned.
Minimum Education and Experience:
Associate's Degree in a relevant science or a related field (e.g. Public Health, Healthcare Administration, etc.).
Applicants may substitute additional related experience such as laboratory, clinical or medical experience for the education requirements on a year-for-year basis.
City: New Brunswick
State: NJ
Physical Demands and Work Environment:
PHYSICALDEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.
WORKENVIRONMENT: Exposure to blood, urine, sputum, excrement, anti-neoplastic agents and possible exposure to infectious and communicable diseases that requires use of personal protective equipment.
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.