Clinical Research Nurse

Job Title:

Clinical Research Nurse

Job Description

The primary purpose of the Clinical Research Nurse is to ensure the successful, patient-oriented, safe, and effective conduct of clinical trials. This role involves assisting investigators in preparing and implementing new clinical trials, screening and enrolling study participants, and providing protocol-related clinical management to those participants while on study.

Responsibilities

+ Collaborate with the Protocol Activation office to initiate and activate all new clinical trial protocols using the Study-start up task list.

+ Prepare and review study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.

+ Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation.

+ Review protocols and collect multidisciplinary logistical, educational, and financial feedback to identify potential obstacles to study conduct.

+ Perform nursing education to other disciplines for safe, effective care of enrolled patients.

+ Translate finalized protocol treatment plans into sample orders.

+ Ensure timely prescreening of potential subjects and active cancer patients for clinical trials.

+ Review patient charts and medical history to confirm protocol eligibility and obtain source documents.

+ Follow informed consent processes to ensure that IRB approved consent has been obtained and documented.

+ Provide backup support to register consented research patients and input data into clinical trials database.

+ Serve as a resource for Clinical Trial Billing Information.

+ Coordinate protocol-specified procedures and treatments for study patients across disciplines/sites of care.

+ Manage patient reimbursement while on clinical trial and coordinate hands-on oncology nursing care.

+ Provide nursing assessment and documentation for study patients, ensuring accurate protocol adherence.

+ Collaborate with medical staff to ensure timely delivery of services to patients.

+ Grade adverse events and document toxicities as per protocol requirements.

+ Complete Serious/Unexpected Adverse Event (SAE) forms and ensure follow-up reports are accurate.

+ Assess overall protocol compliance and assist with deviation reporting.

+ Ensure bio-specimens are collected and processed according to protocol guidelines.

+ Assist with monitoring visits, audits, and sponsor queries.

+ Maintain research records for screened and enrolled patients.

+ Model professional responsibility and performance, and strive for professional growth.

+ Demonstrate competence in utilizing computerized systems required for clinical tasks.

+ Participate in training programs, quality assurance activities, and professional development.

+ Ensure adherence to Institutional, State, and Federal regulations and maintain mandatory educational requirements.

Essential Skills

+ Bachelor's Degree in Nursing preferred.

+ License to practice nursing in the State of New Jersey.

+ One (1) year of oncology experience required.

+ Three (3) to five (5) years of oncology research experience preferred.

+ Active Basic Life Support (BLS) certification.

+ Oncology Nursing Society (ONS) certification as an Oncology Certified Nurse (OCN) or Advanced Oncology Certified Nurse (AOCN) preferred.

+ Certification from the Association of Clinical Research Professionals as a Clinical Research Analyst (CRA) or Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional (CCRP) preferred.

+ Proficiency in computer applications such as Word, Excel, etc.

+ Excellent communication and interpersonal skills.

Additional

Skills & Qualifications

+ Detail-oriented with excellent organizational skills.

+ Experience and comfortability communicating with patients.

+ Ability to maximize resources and be resourceful.

+ Equivalent education, experience, and/or training may be substituted for the degree requirement.

Work Environment

The work environment involves being part of a statewide, national, and world leader of scientific discovery and patient care in cancer research. The role supports the conduct of innovative research and patient-centered care…