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…