Clinical Research Nurse Coordinator

Description:

Protocol Activation:

a. Collaborates with Protocol Activation office to initiate and activation all new clinical trial protocols assigned utilizing Oncore Study-start up task list.

b. 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.

c. 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).

d. Performs one on one or group protocol related nursing education to other disciplines to facilitate safe, effective care of enrolled patients.

e. Translates finalized protocol treatment plan, study calendar and clinical trials billing grid into sample orders.

2. Study Accrual:

a. Collaborates with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials.

b. Reviews patient’s charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed.

c. 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.

d. Obtain informed consent for both therapeutic and non-therapeutic studies as assigned in accordance with IRB, GCP, and institutional policies and procedures.

e. 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

f. 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.

3. Clinical Nursing Responsibilities:

a. Serves as an essential link between patients and all other members of the research team.

b. 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.

c. 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.

d. 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)

e. Coordinates patient reimbursement while on clinical trial, including Rutgers issued or study-specific ClinCards.

f. 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.

g. Appropriate to attain/maintain OCN certification.

h. Provides nursing assessment of study patients by phone or in person – identifies and routes patient as indicated to meet additional or urgent care needs.

i. 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.

4. Study Responsibilities

a. 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.

b. 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.

c. 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.

d. 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.

e. 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.

f. 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.

g. Assists the clinical study team to complete Case Report Forms (CRFs) and/or resolve database queries as needed.

h. Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for screened and enrolled patients.

5. Maintains and role models a high level of professional responsibility and performance.

6. Strives to grow professionally through continuing education and skill building (interpersonal, computer, technical, etc.) Maintains state and certifying body-mandated continuing education requirements. Identifies professional goals and action steps to attain during each fiscal year.

7. Demonstrates competence in utilizing computerized systems as required (Sunrise Disease/Clinical Manager, Oncore™, IDX, TDS, Medical Records database, etc.). Demonstrates basic knowledge to accomplish core tasks (SAE completion, access protocol attachments via Oncore™, enter charts into Medical Records Database, format and print patient study calendars, etc.).

8. Attends Training Programs, Modules, workshop, and seminars sponsored by OHRS as applicable; Actively participates in disease specific DSG meetings; quality assurance activities such as audits and meetings with the Principal Investigator, when directed by supervisor, to keep up-to-date on departmental objectives. Participates on taskforce and/or committees as applicable and/or other process improvement initiatives as assigned.

9. Provides training, orientation and preceptorship to other faculty and staff as needed.

10. Ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures that research protocols are approved by the Institutional Review Board and followed as written.

11. Maintains up-to-date knowledge and adheres to policies, procedures, guidance, and practice standards set forth by RBHS, FDA, and all regulatory bodies. Documents and maintains mandatory RBHS employee requirements such as Blood Borne Pathogens, Right-to-Know, Tuberculosis, Hand-Washing, as defined by Environmental & Occupational Health & Safety Services (EOHSS), Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and other institutional requirements.

Additional Skills & Qualifications:

The primary purpose of the Research Nurse Clinician (RNC) is to ensure successful, patient-oriented, safe and effective conduct of clinical trials at Rutgers Cancer Institute of New Jersey. The Research Nurse Clinician assists investigators to prepare and implement new clinical trials, screens and enrolls study participants, and provides protocol-related clinical management to those participants while on study. Serves as a resource to other Cancer Institute faculty and staff on available protocols, and general research topics such as FDA, IRB and GCP regulations.

the degree requirement.

Experience Level:

Entry Level

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