Entry Level Clinical Research Protocol Writer Jobs

At Houston Methodist, the Clinical Research Nurse (CRN) - Neurology - Alzheimer position is 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 the 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. FLSA STATUS
Exempt
QUALIFICATIONS
EDUCATION

• Bachelor's degree in Nursing or higher from an accredited school of nursing

EXPERIENCE

• One year acute care or clinical research experience

LICENSES AND CERTIFICATIONS
Required

• 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

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
• Adapts to multiple ongoing priorities with minimal supervision including, organizing work flow and actively participating in problem-solving
• Exhibits strong interpersonal and team player skills with all levels of the healthcare team and assures delivery of excellent customer service to all patients, visitors, physicians and co-workers
• Possesses basic computer knowledge; operates multiple computer systems to include, Hospital Information Systems and Office software to maintain patient and exam documents

ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS

• Uses therapeutic communication, which includes active listening and teaching, to provide research interventions care to clinical research patients and coordinates with interprofessional team as written in the research protocol. Contributes to teamwork by consistently responding positively to requests for assistance.
• Provides patient education regarding disease process and involves patient and family 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 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.
• 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 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 perform 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

• Assisting 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.
• 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 on-going basis.

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE
• Uniform: Yes
• 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.
• On Call* No

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:

Non-clinical Houston Methodist is one of the nation's leading health systems and academic medical centers. The health system consists of eight hospitals: Houston Methodist Hospital, its flagship academic hospital in the Texas Medical Center, seven community hospitals and one long-term acute care hospital throughout the Greater Houston metropolitan area. Houston Methodist also includes a research institute; a comprehensive residency program; international patient services; freestanding comprehensive care clinics, emergency care and imaging centers; and outpatient facilities. Come lead with us!

Houston Methodist is an Equal Opportunity Employer.