Job Description

Assignment Duration: 6 months with possibility to extend

Shift Schedule: Per Diem. Working 3rd Shift 10:30PM - 7:00AM any day Monday - Sunday, on call.

This is a per diem position therefor 40 hours are not guaranteed weekly.

Staff will receive assigned shifts at least a week prior. When scheduled, the worker is expected the work the 8 hour shift. This is a per diem position and hours can vary per week.

Core Essential Skill sets candidates should have to be considered for the role:

• Must be a Registered Nurse
• Hospital experience
• Able to handle emergencies
• Has health care experience
• Draw blood
• Have IV skills

Job Summary:

The Clinical Research Nurse is a primary point of contact for study participants, the Primary Investigator (PI), the Clinical Study Manager (CSM), and Department Managers in all study conduct and/or participant-related matters on the clinical research unit floor.

Essential Functions

• Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP’s), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable
• Oversees and monitors the well-being and safety of study participants by active assessment as well as by serving as a visible point of contact at all times
• Facilitates verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensures appropriate follow-through
• Assists the PI with the review of laboratory data results for both the selection and randomization of study participants and for the monitoring of safety parameters while study conduct is ongoing
• Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs), ensures proper documentation and reporting of all AEs, including follow up of open AEs when subjects are not in-house, and provides any appropriate clinical care or instructions to subjects, as directed by the PI or as deemed medically necessary by their professional judgment
• Continuously communicates the progress of study conduct to PI, CSM, and members of the clinical study team through various methods of communication
• Immediately notifies the PI, CSM, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event (SAE) by a study participant and initiates documentation of the event
• Enforces rules and regulations with study participants and handles participant complaints efficiently and effectively, maintaining participant satisfaction
• Maintains compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study
• In the absence of the Clinical Study Manager, performs as the floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor
• Demonstrates professionalism and provides leadership to the various members of the clinical study team
• Administers study medication according to study protocol, demonstrates thorough understanding of study medications, and administers concomitant medication as directed by the PI and maintains accurate and timely documentation of the process
• Coordinates with the scheduling department to ensure coverage of clinical conduct activities
• Works with CSM and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction and feedback as needed
• Oversees the completion of all End of Study or Early Termination activities by study participants, inclusive of follow up for the close-out of any outstanding items (i.e. AEs, physical exams, lab repeats, etc.) after subjects have been discharged from the clinic
• Provides administrative and operational support to ensure successful conduct of study protocols

Qualifications:

• Education A nursing degree and in-state licensure is required.

Experience

• One to two (1-2) years of experience in a clinical research environment
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific experience listed above.

Certification/Licensure Advanced Life Support (ALS) required

Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)

• Possesses leadership skills and abilities
• Able to provide excellent customer service, with experience in public relations
• Able to communicate professionally and effectively both verbally and in writing with participants from diverse backgrounds
• Able to work independently and handle multiple competing priorities
• Able to multi-task working within tight deadlines
• Able to function independently within a team environment
• Possesses excellent organizational and time-management skills and a strong attention to detail

Physical Requirements and Working Conditions:

• Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 50 pounds.

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