At Houston Methodist, the Clinical Research Nurse (CRN) position is a licensed clinician who is responsible for, with minimal supervision, supporting, facilitating, and coordinating the daily clinical trial activities and plays a critical role in the conduct of the study. This position functions at the Competent level according to the Benner's model of clinical practice. The CRN provides direct patient care effectively and efficiently to research patients under the supervision of the Clinical Trials Manager and Principal Investigator. This position implements clinical research patient care via the research protocol. The CRN position works with the Performance Improvement department, sponsor, and institution to support and provide guidance on the administration of GCP compliance, financial and other related aspects of the research study. This position serves as a liaison between physicians, patients, staff, and sponsors. The CRN position delivers exceptional patient care and adheres to standards and guidelines established by regulatory agencies and Houston Methodist to ensure optimal patient safety and customer service.
PEOPLE ESSENTIAL FUNCTIONS
- Uses therapeutic communication, which includes active listening and teaching, to provide research interventions care to clinical research patients and coordinates with the interprofessional team as written in the research protocol. Contributes to teamwork by consistently responding positively to requests for assistance.
- Provides patient education regarding disease processes and involves patients and families in decision-making processes. Consistently evaluates the patient's comprehension and adapts teaching methods accordingly. Advocates on patient/family's behalf to identify and resolve clinical and ethical concerns, utilizing appropriate resources.
- Facilitates onboarding and orientation process for new staff in conjunction with Clinical Trials Manager. Precepts new clinical research staff in the clinical setting. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.
SERVICE ESSENTIAL FUNCTIONS
- Demonstrates ability to manage multiple projects at different stages of the clinical research process (Phase 1-Phase 4).
- Coordinates pre-site and site initiation visits; trains hospital and clinic nurses/physicians on scientific aspects and protocol requirements of research studies. Attends off-site investigator meetings.
- Provides comprehensive nursing assessments to develop, coordinate, implement, and evaluate activities associated with all phases of clinical research projects. Monitors safety of all research subjects and reports adverse events. Practices in a manner that is congruent with cultural diversity and inclusion principles.
- Helps drive improvement of department score for patient satisfaction through peer-to-peer accountability to service standards.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
- Follows the clinical research protocol and nursing process and modifies care based on continuous evaluation of the research patient's condition. Performs nursing functions independently and in collaboration with the Principal Investigator as approved by Hospital administration for the conduct of clinical research.
- Collects, processes, and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification as well as performs study closeout procedures including post-study documentation, return of study materials to the sponsor, and data archiving.
- Collaborates and prepares with Principal Investigator, Institutional Review Board (IRB), and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate and required by the research protocol. Follows International Council for Harmonisation/Good Clinical Practice guidelines.
FINANCE ESSENTIAL FUNCTIONS
- Assists financial analysts in the development of calendar and Medicare Cost Analysis, standard of care procedures vs. research, and approving study calendars for Clinical Trials Management System.
- Identifies, recruits, and consents clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies as necessary.
- Enters study-related data into Clinical Trials Management System (CTMS) in accordance with Houston Methodist Research Institute policy.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
- Identifies and presents areas for innovation, efficiency, and improvement in patient care operations using evidence-based practice literature. Offers innovative solutions through evidence-based practice/performance improvement projects and activities.
- Maintains accountability for ongoing professional growth and development. Participates in unit activities. Completes and updates the individual development plan (IDP) on an ongoing basis.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
EDUCATION
- Bachelor's degree in Nursing or higher from an accredited school of nursing
WORK EXPERIENCE
- One year of acute care or clinical research experience
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