Rutgers, The State University of New Jersey, is seeking an Oncology Clinical Research Coordinator II, for the Office of Human Research Services (OHRS) Department at the Rutgers Cancer Institute of New Jersey.
The primary purpose of the Oncology Clinical Research Coordinator II (OCRC II) position is to serve as a core member of the Cancer Institute of New Jersey's (CINJs) multidisciplinary oncology clinical research team. Responsible for the extrapolation, collection, compilation and submission of study data, including, but not limited to, patient registration, treatment plans, adverse event documentation and reporting, clinical response, and long-term follow-up. Provides overall study coordination and ensures protocol compliance per Food and Drug Administration (FDA), National Institutes of Health (NIH), Code of Federal Regulations (CFR), Good Clinical Practice (CGP) 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.). Demonstrates competency in recognizing the unique needs of patients of all ages, neonate (birth–28 days), infant (29 days– less than 1 year), pediatrics (ages 1-12 years), adolescent (13–17 years), adults (ages 1864 years), and geriatrics (age 65+).
Among the key duties of this position are the following:
Works with the Protocol Activation Office to coordinates the initiation and activation of all new clinical trial protocols assigned. This includes, but is not limited to, verifying Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans and finance/contract approvals prior to study activation. Coordinates the preparation of study tools including but not limited to study binders, medication diaries, eligibility checklists and flow sheets (as required).
Using OnCore®/Excel®/Word®, develops study tools, including but not limited to eligibility checklists, medication diaries, calendars, and flow sheets (as required).
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 OnCoe® 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, Case Report Forms (CRF), 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).
Three to five (5) years of research related experience or two (2) years of research related experience with CCRC/CCRP certification, strong research specific knowledge base.
Equivalent experience, and/or training may be substituted for the education requirements.
Required Knowledge, Skills, and Abilities:
Solid knowledge of computer software programs such as Excel®, Word®, and/or Access®.
The ideal candidate will be detail orientated, have excellent organizational, communication and interpersonal skills, hold self accountable to high standards of professional excellence, be able to maximize resources and be resourceful, seeks and accepts personal and professional responsibility on a continued basis.
Able to function independently and adjust hours to meet job demands.
Understanding of the software program Oncology Collaborative Research Environment (Oncore®).
Association of Clinical Research Professional (ACRP) certification as a Clinical Research Coordinator (CRCC) or Clinical Research Associate (CRA) or Society of Clinical Research Associates (SoCRA) certification as a Clinical Research Professional (CCRP).
Posting Number: 20ST0414
Location: Newark (RBHS)
Internal Number: 111273
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.