The Senior Clinical Research Nurse (CRN) position is responsible for the support and facilitation of the daily clinical trial activities and plays a critical role in the conduct of the study. This position functions at the Proficient level according to Benner's model of clinical practice. The Senior CRN position provides direct clinical research patient care effectively and is considered an expert in the specialty of clinical research inclusive drug and device trials. Role modeling compassionate communication with physicians and the interprofessional health care team, this position assists in coaching and mentoring department staff in areas of clinical research and professional research nursing practice. The Senior CRN position is a subject matter expert in implementing clinical research care via the research protocol. This position functions as a resource for the Principal Investigator (PI), department, sponsor, and institution, providing guidance on the administration of Good Clinical Practice compliance, financial and other related aspects of the research study. The CRN position serves as a liaison between physicians, patients, staff and sponsors.
FLSA STATUSExempt
QUALIFICATIONSEDUCATION- Bachelor's degree or higher from an accredited school of Nursing
EXPERIENCE- Five years clinical research experience
LICENSES AND CERTIFICATIONSRequired- RN - Registered Nurse - Texas State Licensure - Texas Board of Nursing_PSV Compact Licensure - Must obtain permanent Texas license within 60 days (if establishing Texas residency) and
- BLS - Basic Life Support or Instructor (AHA) - American Heart Association and
- Must have one of the following certifications:
CCRC - Certified Clinical Research Coordinator (ACRP) or
CCRP - Certified Clinical Research Professional (SOCRA) or CRN-BC - Certified Research Nurse (CRNCC)
SKILLS AND ABILITIES- Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
- Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
- Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
- Demonstrates clinical problem solving and critical thinking using an analytical approach
- Acts as effective change agent
- Uses therapeutic communication to establish a relationship with patients, families and interprofessional team to collaborate on the plan of care
- Strong assessment, organizational and problem solving skill as evidenced by capacity to prioritize multiple tasks and role components
- Ability to function independently and exercise judgment in interactions with physicians, interprofessional care team and patients and their families
- Demonstrates proficient time management skills
- Uses critical thinking skills and clinical judgment to work autonomously as defined by the Nurse Practice Act
ESSENTIAL FUNCTIONSPEOPLE ESSENTIAL FUNCTIONS- Functions in lead role for studies and provides back up to other team members for research studies. Provides patient education regarding disease process and involves patient and family in decision-making process, providing research interventions care to clinical research patients and coordinates with interprofessional team as written in the research protocol.
- Identifies staff development opportunities for professional growth of colleagues, provides coaching to meet identified goals. Acts as a model and coaches staff in effective verbal, non-verbal and written communication, which includes active listening and teaching. Facilitates onboarding and orientation process for new staff in conjunction with Clinical Trials Manager. to include precepting new staff and serve as a resource to new staff for clinical research.
- Improves nurse satisfaction by serving as a role model and mentor, facilitating teamwork with RNs, non-licensed and interprofessional staff. Leads opportunities for improvements of department scores for turnover/retention/engagement.
SERVICE ESSENTIAL FUNCTIONS- Coordinates with Principal Investigator and department to ensure clinical research and related activities are performed in accordance with Federal regulations and Houston Methodist Research Institute policies and procedures.
- Coordinates pre-site and site initiation visits; trains hospital and clinical nurses/physicians on scientific aspects and protocol requirements of research studies. Attends off-site investigator meetings.
- Role models accurate, 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. Drives department activities to improve department score for patient satisfaction on unit-based scorecard.
QUALITY/SAFETY ESSENTIAL FUNCTIONS- Manages study quality assurance and actively participates in quality assurance program for research studies. Proactively plans for routine events in research and anticipates/prevents and manages/elevates emergent situations. Tracks and monitors study quality for studies in area of expertise.
- Assists Principal Investigator to ensure that all persons 'engaged' in research studies have met training requirements in accordance with Federal regulations and entity policies and procedures including preparing Institutional Review Board (IRB) and regulatory documents following ICH/GCP guidelines, and the development of materials and tools necessary to appropriately facilitate the conduct of research.
- Assists with development of study tools including source documents and eligibility checklists and criteria cards, as well as performing study closeout procedures to include post-study documentation, return of study materials to the sponsor and data archiving.
- Leads initiatives to improve quality and safety scores, through peer-to-peer accountability Performs nursing functions independently while following the clinical research protocol and nursing process which would include, modification of care based on continuous evaluation of the research patient's condition. Role models situational awareness, using teachable moments to improve safety.
FINANCE ESSENTIAL FUNCTIONS- Models independent time management effectively and prioritization of daily tasks. Assists with budget development and institutional account reconciliation of protocol-driven ancillary procedures and tests.
- Assists the financial analyst in development of calendar and Medicare Cost Analysis, standard of care procedures vs research and approving study calendars for Clinical Trials Management System.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS- Identifies, recruits, and consents clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies, as necessary.
- Maintains level of professional contributions to improve clinical research nursing. Leads and identifies opportunities for practice changes and performance improvement. Investigates and incorporates evidence-based practices which are presented to leadership. Supports change initiatives and adapts to unexpected changes. Completes and updates My Development plan on an on-going basis.
SUPPLEMENTAL REQUIREMENTSWORK ATTIRE- Uniform: No
- Scrubs: Yes
- Business professional: No
- Other (department approved): No
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.
TRAVEL**
**Travel specifications may vary by department**- May require travel within the Houston Metropolitan area No
- May require travel outside Houston Metropolitan area No
Work Shift:
1 - Day (United States of America)
Job Category:
Clinical
