Feb 18, 2020

Research Nurse-Pediatric Cardiothoracic Surgery

  • The Children's Hospital of Philadelphia
  • Philadelphia, PA, USA

Job Description

Job Summary

Job Summary

Clinical Research Nurse Coordinator coordinates clinical research activities of the Neurocardiac Research Program (NCRP) within the clinical divisions of the Cardiac Center. Facilitates the conduct of clinical research by providing care to research participants as well as activities to support protocol implementation, data collection, and human subject protection. Provides specialized education concerning clinical research studies. Within the scope of clinical research protocols, participates in direct patient care. 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 and other sources.

Preferred applicant:

Bachelor of Science in Nursing

5 or more years of pediatric nursing, preferably in pediatric cardiac nursing

2-3 years clinical research experience preferred

Successful performance in a high-intensity work environment.

Excellent problem identification and problem solving skills. Flexibility.

Ability to work in teams and to work autonomously

Knowledge of computers and appropriate software packages.

Ability to handle multiple tasks.

Excellent interpersonal communication, organizational and managerial skills.

Job Responsibilities

Human Subject Protection: The clinical research nurse coordinator demonstrates leadership in ensuring adherence to ethical practices during the conduct of research studies in order to protect the rights and well being of patients and the collection of quality data.

  • Understands the relevance of the historical development of clinical research to current research and policy
  • Advocates for ethical care of clinical research study patients and the conduct of clinical research in accordance with standards of nursing practice.
  • Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, respect for persons, beneficence, and justice.
  • Ensures that members of vulnerable populations enrolled in clinical trials are identified and that their rights are addressed.
  • Contributes to the preparation of documentation and submissions for IRB (ethical) approval.
  • Manages potential ethical and financial conflicts of interest for self
  • Identifies and follows institutional procedures to report any falsification of data or scientific misconduct.

Job Responsibilities

Management of clinical research study protocols: The clinical research nurse coordinator demonstrates leadership in ensuring protocol compliance, financial compliance and effective clinical research study related communication.

  • Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of then needs of cardiac center patient population.
  • Identifies the financial variables that affect research and supports good financial stewardship in clinical research studies.
  • Utilizes multiple communication methods to facilitate the effective conduct of clinical research studies

Management of potential and enrolled clinical research study patients [subjects]: The clinical research nurse coordinator demonstrates leadership in ensuring appropriate care for patients during all steps of the research process- recruitment, informed consent and study participation.

  • Utilizes a variety of strategies to enhance recruitment while being mindful of the needs of diverse patient populations.
  • Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing clinical research study informed consent discussions.
  • Uses a variety of resources and strategies to manage the care of patients participating in clinical research studies, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms
Job Responsibilities

Data Management: The clinical research nurse coordinator provides leadership to the research team in ensuring collection of source data and completion of documentation that validate the integrity of the conduct of the clinical research study.

  • Complies with regulations, institutional policies, and sponsor requirements governing source data and documentation.
  • Documents assessment, management, and evaluation in source documents for patients in clinical research studies as appropriate to the protocol and role.
  • Educates research and clinical team members regarding appropriate and accurate source documentation for participation in clinical research studies
  • Ensures that relevant data from the source document are abstracted and recorded in the clinical research study case report forms and that every data point can be verified within the source document.
  • Follows appropriate guidelines in making corrections to data entry in clinical records and case report forms as recommended by good clinical practices, standards, or institutional procedures.
  • Ensures that all regulatory documents are processed an maintained per institution, IRB, and GCP regulations
  • Demonstrates proficiency in the use of clinical and research-related computer programs/applications.
Required Licenses, Certifications, RegistrationsRegistered Nursing License in the Commonwealth of Pennsylvania or in the State of New Jersey, depending on the assigned work location.CPR CertificationRequired Education and Experience

Required Education: Bachelor of Science in Nursing (BSN) degree

Required Experience: Three (3) years of experience in nursing or research

Preferred Education, Experience & Cert/Lic

Preferred Licenses/certificates/registrations: ACRP or SOCRA

Job Requirements

Scientific contribution: The clinical research nurse coordinator contributes to science by supporting the preparation and dissemination of research data, development of new ideas for study, mentorship of students, and own professional development.

  • Participate in the query and analysis of research data.
  • Assist in the preparation of manuscript and poster presentations
  • Generate practice questions as a result of a new study procedure or intervention.
  • Collaborate with the interdisciplinary team to develop innovations in care delivery that have a potential to improve patient outcomes and accuracy of data collection.
  • Identify new questions as a result of study team participation
  • Perform secondary data analysis to contribute to the development of new ideas.
  • Mentor junior staff and students participating as members of the research team.
  • Serve as a resource to a new investigator
  • Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing colleagues.
  • Participates in educational opportunities to increase knowledge about clinical research, regulations and guidance, and the role of the clinical research nurse coordinator.