Per Diem Clinical Licensed Vocational Nurse (LVN) - Elixia

• Hours are 4:30pm - 4:30am PST
• This will be a per diem role
• Must be willing to pick up 2 - 3 shifts per week
• Fluency in English and Spanish is a plus

• Obtains, processes, and ships laboratory samples (e.g., blood, urine, etc.) as per protocol. 
• Assist and support patient education on completion of diary, questionnaires and logs required in trial (if applicable)   
• Provides nursing standard of care in subjects admitted and seen in a clinical research setting, with the supervision of clinical research nurse-registered nurse (when applicable) 
• Ensures subjects’ safety and compliance with the protocol specific lifestyle guidelines.
• Obtains and maintains intravenous access on subjects admitted.
• Administers investigational product.
• Assess adverse events and drug reactions – seek medical intervention for patients when appropriate.
• Reporting all adverse events (AEs), and serious or unexpected adverse events (SAEs) to the investigator and assisting the Investigator in reporting to the Sponsor/IRB all AEs/SAEs, as the protocol and regulations require
• Perform all protocol related procedures including, but not limited to vital signs, ECGs, phlebotomy, finger sticks, mouth swabs, spirometry, urine dipsticks, drug screens, pregnancy tests, etc.
• Adequately document study procedure collection via progress notes, adverse event information observed and/or reported along with procedures performed during clinical trial.
• Obtain lab reports, procedure reports and ensure investigator reviews all lab results in form of full signature along with providing clinical significance to any out of range and/or abnormal value.
• Dispense and monitor allowed concomitant medication intake. 
• Dispense and monitor cigarette intake. 
• Inventory of Medical supply
• Conducts Quarantine and recall procedures. 
• Maintains Crash cart inventory and contents.
• Facilitates DRP and ER plans in the event of an emergency. 
• Attend Site initiation visits and/or training in-service for all protocols.
• Maintain current Safe-t-pack biohazard training certification or IATA equivalent, (ACLS) advance life support certification, OSHA, and site’s SOP (SWP) training. 
• Have in depth knowledge of company SOPs, ICH GCP guidelines and protocols assigned, specifically inpatient segment and safety criteria.
• Assists in documentation of medical and surgical history, concomitant medication use, preliminary complaints, and lifestyle practices. 
• Documentation of inpatient activities, progress notes, adverse events observed and/or reported and performed during clinical trial.
• Supports reinforcement of study restrictions, diets, and study guidelines 
• Assists in obtaining lab reports, procedure reports and filing, specifically day -1 and/or unscheduled collected while inpatient.
• Assists in preparation of collection tubes, vials, and study supplies for visits, including PK/PD set up.
• Continuous observation and patient monitoring to ensure subjects’ safety and compliance with the protocol, restrictions, and specific guidelines. 
• Conducts assessment procedures as required by protocol (vital signs monitoring, electrocardiogram, etc.) under CRC and/or nurse supervision. 
• Maintains inpatient temperature Freezer, Refrigerator, and room logs. 
• Reports Temperature Excursions
• Other responsibilities as deemed appropriate by the management.

• An LVN (or RN) license  
• Previous research experience and/or background are preferred. 
• Research Nurse is expected to maintain nursing license, ACLS certification for LVN or RNs and a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices.

• ACLS certification
• Basic Cardiac Life Support 

• Excellent communication skills 
• Critical thinking skills.
• Planning /Organizational Skills 
• Personal Motivation
• Customer Service Skills

• Understanding of ICH/GCP guidelines for human research
• Understanding of Code of Federal Regulations for Human Subject 
• Computer Competency in Electronic Data Capture
• Understanding Phases I-IV drug development process.
• ECG, Phlebotomy skills and other technical skills related to completion of study visits as required by the protocol.

• No Travel required.
• Exposure to human bodily fluids.
• Laboratory Processing Procedures.
• Subject/Patient Care.
• Mid-level Computer Use.
• Weekend work schedules as needed. 
• Work is normally performed in a typical interior clinical/office environment.
• Lifting of twenty pounds and occasionally more than twenty pounds.

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