The clinical research nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by regulations. The clinical research nurse will provide patient care, perform ongoing assessments, and document in accordance with standards and regulatory guidelines pertaining to specified research patients enrolled onto clinical trials, when needed by the research team.
ESSENTIAL JOB FUNCTIONS
Responsible for following all study and non-study regulations including but not limited to: HIPAA, OSHA, and GCP/GDP; as well as proper safety and emergency policies and procedures as set forth by WCCT
Complete study procedures, including but not limited to vital signs, electrocardiogram, blood collection, meal distribution, pulmonary function tests, check in/out of volunteers, urine/stool sample collection, CSF collection, IV insertions and med administration (including IM, SW, rectal, oral, and IV fluid administration)
Perform all forms of dose administration, as allowed per licensure, included but not limited to: IV, IM, SQ and oral, etc.
Perform nursing assessments and monitor subjects' progress during clinical studies and notify PI/CRC/CN of any adverse events and serious adverse events, including evidence of unexpected side effects. Perform interviews, as needed, during each subject visit and follows procedures as specified per protocol.
Enter subject information into subject source/facility database, and QC entries, as needed.
May cross-train to cover Charge Nurse in case coverage is needed; must be able to do the following when covering:
Consistently monitor and manage the conduct all protocols, staff, and subject population within the Clinical Support Department
Ensure safety and compliance of floor
Develop and serve as a resource to ensure staff’s skills are maintained and enhanced
Be able to provide medical care, both emergent and non-emergent, to all subjects and floor staff if needed
Assist Clinical Research Coordinators with study responsibilities and necessities
Duties on the floor: Atomic Clock synchronization, Maintain work area cleanliness of unit, Assist in head count of subjects in-house, Assist in the Quality Control of: tubes, source/PK logs, procedures, Assist with preparation of ALL study set-ups, Assist with the maintenance of supplies and equipment for all study relate procedures, Prepare for and assist with admission procedures, Assist with room assignments for studies
EDUCATION, EXPERIENCE, CERTIFICATES, LICENSES AND TRAINING
High school diploma or General Education Degree (GED), 3-6 months related experience and/or training, or the equivalent combination of education and experience is required.
Associate’s degree or higher in Nursing
Study-related training prior to performing study-related procedures
Module 1, 2, 3, 6, 7 training required
Ability to read and interpret documents such as Standard Operating Procedures (SOP), safety rules, study-related forms and documents. Ability to write routine reports and accurately record information on forms and/or documents. Ability to effectively communicate with subjects, employees, supervisors, and others on study-related matters in English is necessary
Certificates & Licenses
Current BLS/ACLS certification is required
Current PALS certification is preferred
Registered Nurse (RN) license is required
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
The description of the physical demands and the work environment characteristics here represent those that must be met by an employee to successfully perform and those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job:
Ability to talk or hear.
Required to sit 90% of the workday.
Occasionally required to stand; walk.
Must be able to use hands to finger, handle, or feel; reach with hands and arms.
Minimal lifting is required, 10 pounds, with assistance and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus when viewing a computer monitor.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals and risk of electrical shock.
The noise level in the work environment is usually low.