Work Shift: DAY
Work Week: Varies
With minimal supervision, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The Clinical Research Nurse II (CRN) II provides direct patient care effectively and efficiently to research patients under the supervision of the Clinical Trials Manager and Principal Investigator. The CRN II implements clinical research patient care via the research protocol. Mentors and train new clinical research staff and nurses. The CRN II works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the GCP compliance, financial and other related aspects of the research study. Serves as a liaison between physicians, patients, staff and sponsors.
DUTIES AND RESPONSIBILITIES
¿ Provides research interventions care to clinical research patients and coordinates with interdisciplinary team as written in the research protocol.
¿ Functions in lead role for studies and provides back up to other team members for research studies.
¿ Facilitates onboarding and orientation process for new staff in conjunction with CTM.
¿ Coordinates with Principal Investigator, department to ensure clinical research and related activities are performed in accordance with Federal regulations and HMRI policies and procedures.
¿ Demonstrates ability to manage multiple projects at different stages of the clinical research process (Phase 1-Phase 4)
¿ Establishes and organizes study files, including but not limited to regulatory binders, study binders, study specific source documentation and other materials.
¿ 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.
¿ Provides patient education regarding disease process and involves patient and family in decision-making processes.
Quality and Safety
¿ Manages study quality assurance and actively participates in quality assurance program for research studies. Track and monitor study quality for studies in area of expertise.
¿ Following the clinical research protocol and nursing process, modifies care based on continuous evaluation of the research patient¿s condition, demonstrates clinical problem solving and critical thinking using an analytical approach.
¿ Plans for routine events in research and anticipates/prevents and manages/elevates emergent situations.
¿ Contributes to research department targets for quality and safety measure.
¿ Assists Principal Investigator to ensure that all persons `engaged¿ in research studies have met training requirements in accordance with Federal regulations and HMRI policies and procedures.
¿ Assists with development of study tools including sources documents and eligibility checklists and criteria cards.
¿ Performs nursing functions independently and in collaboration with Principal Investigator as approved by Hospital administration for the conduct of clinical research.
¿ Collects and enters study data on manual or electronic case report forms according study protocol and contract requirements
¿ Collects, processes and ships protocol-required lab specimens; maintains supply and equipment inventory; maintains appropriate laboratory certification.
¿ Maintains inventory and accountability of investigational products and supplies; maintains appropriate logs.
¿ Monitors source documents and case report forms for completion and accuracy; assists with quality assurance processes.
¿ Perform study closeout procedures including post-study documentation, return of study materials to the sponsor and data archiving.
¿ Assists the PI in development of materials and tools necessary to appropriately facilitate the conduct of research studies around issues related to protocol requirements, schedule of visits, execution of research plan, maintains documentation of training.
¿ Reviews and comprehends the research protocol.
¿ Collaborates and prepares with Principal Investigator Prepares IRB and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate and required by the research protocol. Follows ICH/GCP guidelines.
¿ Assists with budget development and institutional account reconciliation of protocol-driven ancillary procedures and tests.
¿ Assisting financial analyst in development of calendar and Medicare Cost Analysis. standard of care procedures vs. research and approving study calendars for CTMS
¿ 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 CTMS in accordance with HMRI policy
Growth and Innovation
¿ Maintains level of professional contributions to improve clinical research nursing.
¿ Facilitate shared governance for clinical research nursing.
¿ Precept new clinical research staff in clinical setting.
¿ Maintains accountability for ongoing professional growth and development. Participates in unit activities..
¿ Performs other duties as assigned.
Minimum of 3 years acute care/clinical research experience.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
Current Registered Nurse Licensure in the State of Texas
Certified Clinical Research Coordinator preferred
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
¿ Requires highly effective communication skills.
¿ Requires highly effective time management skills
¿ Requires ability to understand and implement protocols.
¿ Requires experience with computer database management.
¿ Requires Microsoft Office skills.
¿ Requires strong interpersonal skills.
¿ Extended periods of walking and standing may be required.
¿ Lifting, pushing or pulling required (minimum 50 lbs.)
¿ An Activity Checklist (see final page)
Patient care unit conditions
Universal precautions required
Significant potential for exposure to Latex
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law.
VEVRAA Federal Contractor – priority referral Protected Veterans requested.
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials.
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