Clinical Research Nurse Coordinator III (RN)-Neuro-Oncology/Neurofibromatosis Program at Children's Hospital Of Philadelphia

Company Name
Children's Hospital Of Philadelphia
Job Title
Clinical Research Nurse Coordinator III (RN)-Neuro-Oncology/Neurofibromatosis Program
Company Location
Philadelphia, PA
Contact Information
Required Education
Not Specified
Required Experience
Not Specified
Job Description

Req ID: 15002

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

The Neuro-Oncology/Neurofibromatosis Research Nurse will collaborate with the Neuro-Oncology / Neurofibromatosis (NF) study team in the coordination and conduct of clinical trials according to regulatory, divisional and institutional guidelines and requirements.

  • Responsible for the coordination of clinical research trials as assigned within the Neuro-Oncology section in the Division of Oncology and the Neurofibromatosis Program.
  • Participate in research team meetings, division-wide coordinator meetings and continued education and training within the CHOP Research Institute related to this role.

Expected to attend trainings on good clinical practices (GCP) and research related regulations and responsibilities within the institution and will be held accountable for adherence to all policies and procedures surrounding this process and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.

Function independently in a clinical research setting, responsible for the complete coordination of assigned clinical research activities. May have supervisory responsibilities.

Job Responsibilities

The Research Nurse role will have diverse responsibilities including, but not limited to:  

  • Administratively support the Neuro-Oncology / NF physicians and study team related to research documentation.
  • Work with clinical team and other research staff to order research procedures including research specimens.
  • Ensuring Investigational Agents and study related requirements are ordered according to the protocol.
  • Coordinate PK/PD studies.
  • Provide nursing care, participate in clinical/protocol rounds, and schedule study related tests in the context of research participation.
  • Review study drug medication compliance for subjects enrolled on clinical trials.
  • Administer patient reported outcome forms as required by study protocols.
  • Assist the study PI in the identification and screening of subjects, and in explaining studies to subjects
  • Ensure only eligible subjects are enrolled, confirm source documentation for all eligibility and pre-treatment requirements prior to enrollment.
  • Liaison to patients and families for protocol related questions.
  • Serve as liaison to institutional investigators, nurses and pharmacists for information exchange regarding clinical trials as assigned within the Neuro-oncology/NF programs.
  • Initiate and maintain communication with the principal investigator(s) on the status of active projects, regulatory and protocol performance
  • Participate in the development and implementation of Neuro-Oncology / NF clinical research initiatives
  • Review inpatient and outpatient progress notes and assessments for protocol compliance and grade toxicities.
  • Assist CRA in chart abstraction, completion of case report forms, data clarification, and ensuring appropriate source documentation is maintained according to sponsor and PI requirements.
  • Communicate study noncompliance with principal investigator(s)
  • Ensure accurate reporting of toxicity, SAEs, Unanticipated Problems and Protocol Deviations to the IRB, CRQA and Sponsor.
  • Assist CRA in preparation for and facilitate monitor visits and audits; ensure documentation is adequate for study validation and monitoring / audits.
  • Act as research information resource for Neuro-Oncology / NF protocols
  • Mentor medical staff and contribute to the education of other CRAs/Study Coordinators related to Neuro-Oncology / NF protocols and processes

Demonstrate commitment to patient safety by speaking up about safety issues.  Shares errors or potential errors through system reporting mechanisms.

Perform all CRNC Core and additional responsibilities as detailed for CRNC I and II. Applies in depth knowledge of clinical research and coordinates conduct of complex studies.

  • Manage study finances including sponsor invoicing & resolving study subject billing issues
  • Develop advertisement materials, informed consent document, Case Report Forms
  • Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
  • Document investigational product (drug/device) accountability
  • Self-monitor and self-audit responsibilities
  • Maintain Clinical
  • Act as mentor to others for their professional development
  • Supervise and train new staff
  • Understand  good clinical practice (GCP) and regulatory compliance Comply with Institutional, federal, state, and sponsor policies, standard operating procedures (SOPs) and guidelines
  • Performs a leadership role in developing, implementing, and evaluating the conduct of clinical research

Active in clinical research committees/activities within assigned division or institution.

Required Licenses, Certifications, Registrations

RN - Registered Nurse

CPR - Certified Pulmonary Recuscitation

Required Education and Experience

Required Education: BSN

Required Experience: 5+ years nursing experience

Preferred Education, Experience & Cert/Lic

Preferred Licenses/certificates/registrations: ACRP or SOCRA

•2-3 years of clinical research experience preferred

•Working knowledge of Oncology preferred

Additional Technical Requirements

Specific knowledge and skills:

  • Excellent written and verbal communication skills
  • Strong organizational and time management skills
  • Effective problem solving/critical thinking skills
  • Ability to balance multiple priorities and work independently
  • Attention to detail
  • Requires a high degree of flexibility of hours
  • Flexibility/Adaptability in working in team environment
  • Proficiency in the use of personal computers and software, Microsoft Office Suite, Adobe Professional including web-based database software
  • CHOP mandatories and competencies for nurses and maintenance of a current nursing license
  • Value for research integrity and collaborative research; ability to handle confidential matters and materials

Knowledge of FDA research regulations and Good Clinical Practice (GCP) preferred

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.? Please contact our hiring official with any referrals or questions.? ? CHOP Careers Contact? : Talent Acquisition Address: 2716 S. Street

Philadelphia, PA 19146? ?Phone: 866-820-9288? Email:? ?[Click Here to Email Your Resumé]

Job Requirements