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Invisible Hand in Clinical Research?

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Nurses are underappreciated though they play vital roles in clinical research enterprise

The Clinical Research Nurse (CRN) plays a vital tripartite role in the research enterprise, serving simultaneously as an expert nursing care giver, a member of he scientific team conducting the study, and as the research participants’ advocate who insures that the informed consent process extends throughout the study. Clinical research nurses are at the center of the clinical research enterprise. In collaboration with principal investigators, they assist with protocol development, write consent forms, recruit subjects, explain the study to and obtain consent from subjects, coordinate with relevant hospital/clinic units, collect and maintain clinical data, and serve as the main contact person for subjects during a trial. Briefly, nurses play three critical roles:
(1) Patient Advocacy

(2) Subject Advocacy

(3) Study Advocacy  

In recognition of these trends and in response to this need, Canadian Association of Clinical Research Specialists, CACRS has taken action to insure that nurses are prepared to support the evolving changes in the global clinical research enterprise. These include the dramatic increase in the number of research participants; the movement of clinical trials out of specialized research units into general hospital care areas and more recently into nonhospital, general medical facilities, and the community in the form of pragmatic trials; the increasingly rigorous standards for initial and ongoing informed consent; the increasing sophistication of the scientific questions under study; the rapid evolution of electronic data recording instruments; and the increasing complexity of achieving compliance with all of the regulations governing the performance of clinical research as codified in the Good Clinical Practice (GCP) standards embodied in the Internal Conference on Harmonization E6(R2).

Canadian Association of Clinical Research Specialists, CACRS is offering sustainable model for skills acquisition of CRN and GCP competencies, the skills and competencies of CRN can be acquired by the professional development training programs including essential soft skills and mastered by earning CERTIFIED CLINICAL RESEARCH NURSE designation, CACRS CCRN.

Clinical Research Nurses are the key to success of clinical trials and mostly are behind the scenes. CACRS is very keen to worldwide help nurses in this domain to become appreciated, recognized and differentiated by having their own credentials, CCRN.

Clinical Research Nurse Essential Functions:

  1. Develop and tracks work flow policies, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborate with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trials.
  2. Manage interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
  3. Manage patient care in compliance with the research study or clinical trial protocol requirements. Monitor subject condition while ensuring safety and maintaining confidentiality. Identify patient problems and make adjustments to care plans.
  4. Serve as a patient advocate throughout the research study or clinical trial. Develop and conduct patient and family education.
  5. Administer and implement treatment procedure or drugs, monitor and study their effects, and conduct subject medical evaluations.
  6. Monitor activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Continuously educate and train personnel on compliance and protocol. Identify protocol problems, informs investigators, and assists in problem resolution efforts.
  7. Manage complex research study or clinical trial data. Develop methods for collection, database storage, tracking, analysis, and interpretation of data.
  8. Develop and prepare study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents.
  9. Review proposed study protocols to evaluate factors such as sample collection process, data management plans, and potential subject risks.  Conducts quality assurance audits on data and regulatory documentation.
  10. Attend research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities.
  11. Perform other duties as assigned.

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