Position Summary:

• Collaborates with the Protocol Activation office to initiate and activate all new clinical trial protocols assigned utilizing the OnCore® Study-start up task list.
• This includes but is not limited to the preparation and/or review of study tools such as study binders, medication diaries, eligibility checklists and flow sheets (as required); verification of Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans and finance/contract approvals prior to study activation.
• Reviews protocol; collects multidisciplinary logistical, educational and financial feedback to identify potential obstacles to safe, effective study conduct; actively identifies and resolves obstacles in collaboration with the Principal Investigator (PI).
• Performs one-on-one or group protocol-related nursing education to other disciplines to facilitate safe, effective care of enrolled patients.
• Translates finalized protocol treatment plan, study calendar and clinical trials billing grid into sample orders.

• Collaborates with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials.
• Reviews patient's charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed.
• Follows the required elements of the informed consent process to ensure that IRB approved informed consent has been obtained, signed, placed in the medical record, and that a copy was provided to the patient.
• Obtains informed consent for both therapeutic and non-therapeutic studies as assigned in accordance with IRB, GCP, and institutional policies and procedures.
• Provides back-up support to register 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.
• Provides completed precertification form and anticipated clinical information to Financial Counselor. Responds to queries from payers for additional clinical information. Serves as resource for Clinical Trial Billing Information related to assigned studies as per the billing grid.

• Serves as an essential link between patients and all other members of the research team.
• Actively identifies, addresses, and communicates to study team and supervisor any challenges with completion of protocol required procedures and/or adherence to protocol required timelines.
• Ensures protocol-specific orders are entered and executed accurately, including scheduling and completion of tests and appointments internal or external to the health system as dictated by the protocol and eligibility work-up requirements through the end of study transition to next site of care.
• Coordinates/oversees continuity of protocol-specified procedures and/or protocol-specified treatments for study patients between disciplines/sites of care (including inpatient needs as it relates to the study protocol)
• Coordinates patient reimbursement while on clinical trial, including Rutgers issued or study-specific ClinCards.
• Proactively manages, coordinates and delivers high-quality, compassionate hands-on competent oncology nursing care and coordinates with the assigned clinical team, investigators, and ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) as per protocol requirements and ensures adherence to the treatment plan and GCP guidelines.
• Appropriate to attain/maintain OCN certification.
• Provides nursing assessment of study patients by phone or in person – identifies and routes patient as indicated to meet additional or urgent care needs.
• Provides nursing documentation that is complete and accurate for protocol-specified visits and utilizes applicable institutional templates. Ensures reconciliation of concomitant medications for patients on active study treatment. Ensures clear communication with transition and status of patients who are off treatment and/or off study.

• Drives collaboration with all integrated, academic medical system staff to ensure that services are coordinated and delivered to patients in a timely manner. Assists in the promotion of teamwork and delegates tasks to other groups as appropriate.
• In collaboration with the physician, accurately grades adverse events using the protocol referenced version of National Cancer Institute (NCI) common toxicity criteria or protocol specific grading scales to objectively document toxicities. Provides informal teaching/coaching to clinicians on proper toxicity assessment grading.
• 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. Ensures accurate completion of SAE follow-up reports and that physician attribution has been included in all AE reports.
• In collaboration with assigned team, continually assesses overall protocol compliance and assists with Deviation reporting as per IRB guidelines, institutional policies, and protocol specific requirements.
• Provides back-up support to collaborate with assigned team and the Clinical Trial Lab (CTL) to ensure study specific bio-specimens procured are collected and processed according to protocol specific guidelines, including the submission of pathology materials, serum, blood, urine and tissues samples, and CRFs.
• Assists with monitoring visits and audits as requested. Assists to provide accurate, timely, intelligent responses to sponsor's queries. Schedule and/or participates in conference calls as part of an integrated, academic health system.
• Assists the clinical study team to complete Case Report Forms (CRFs) and/or resolve database queries as needed.
• Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for screened and enrolled patients.

Minimum Education and Experience:

• Graduate of an accredited school of nursing with a license to practice in the State of New Jersey.
• Bachelor's Degree in Nursing required.
• Two (2) years of oncology experience required, one (1) year of which should be in oncology research experience.

City: New Brunswick

State: NJ

Physical Demands and Work Environment:

• Standing, sitting, walking, talking and hearing.
• No special vision requirements.
• Lifting up to 25 lbs.

• Office environment. Moderate noise.

Posting Number: 26ST0706

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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