Details
Posted: 12-Jan-24
Location: New Brunswick, New Jersey
Salary: Open
Categories:
Other Staff/Administrative
Staff/Administrative
Internal Number: 215405
Position Summary:
Rutgers, The State University of New Jersey is seeking a Oncology Clinical Research Coordinator III within the Rutgers Cancer Institute of New Jersey. The primary purpose of the Oncology Clinical Research Coordinator III position is to assist Cancer Institute of New Jersey's multidisciplinary Disease Specific Group (DSG) Clinical Research Teams with conducting clinical trials. Responsible for assisting the clinical research team in overall study coordination, including but not limited to, preparing for study initiation and activation, acquisition of source documents, record maintenance, preparing study documents, patient registration, coordinating and data entry. Serves as a study liaison with study sponsors and provides assistance with overall study coordination that is in compliance with the 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 Cancer Institute of New Jersey and RBHS. Understands and meets/exceeds the needs of all customers (patients, families, study sponsors, monitors, auditors, multidisciplinary team, etc.).
Among the key duties for this position are the following:
- In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews patient's charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed. Under the direction of the RNC and/or physician, ensures that IRB approved informed consent has been obtained, signed, placed in the medical record, and that a copy was provided to the patient.
- Registers consented research patients with study sponsor (e.g., industry, NCI Cooperative group, etc.) and inputs into the OnCore® clinical trials database maintained by the Cancer Institute of New Jersey.
- Coordinates the clinical assessments and patient care of study participants, including but not limited to, screening and evaluation of study participants with ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) within the Cancer Institute as per protocol requirements.
- Maintains research record (e.g., patient consent, eligibility, registration confirmation, corresponding source documents, etc.) for all patients enrolled in Cancer Institute of New Jersey clinical trials across the health system.
- In collaboration with the RNC and physician, assists with grading adverse events using the most recent version of National Cancer Institute (NCI) common toxicity criteria or protocol specific grading scales. Completes Serious/Unexpected Adverse Event (SAE) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements and institutional guidelines.
Minimum Education and Experience:
- Bachelor's Degree in a relevant science or a related field (e.g. public health, healthcare administration).
- 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:
PHYSICAL DEMANDS: Walking, sitting, standing, pushing, pulling, bending and lifting. No special vision requirements. Lifting up to 25 lbs. Possible travel for Investigator meetings. Possible travel to retrieve data from other clinics.
WORK ENVIROMENT: Moderate noise (examples: business office with computers and printers, light traffic). Exposure to blood, urine, sputum, excrement, anti-neoplastic agents and possible exposure to infectious and communicable diseases that requires use of personal protective equipment.
Posting Number: 23ST3049
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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.
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