Clinical Research Nurse
1 week ago
Catalina Research Institute (CRI), an ACRS company is located in Montclair, CA and they focus on Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a Clinical Research Nurse.
The expectation is to work on site in Montclair, CA.
- Hours are 5pm – 5am PST
- This will be a per diem role
- Must be willing to pick up 3 – 4 shifts per month
- Fluency in English and Spanish is a plus
The Clinical Research Nurse provides nursing standard of care in a research environment; Responsible for monitoring study participants, which includes collecting and reporting data on changes in their physical and mental status monitoring drug action and side effects, collecting lab sampling, dispensing, and accounting for investigational product assigned. Provides support to the clinical research coordinator in conducting inpatient portion of clinical trials; extent determined by experience, assignment of duties at the site delegation log, training, and license.
DUTIES AND RESPONSIBILITIES:
- 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.
EDUCATION/TRAINING
- An RN or LVN licensure
- Previous research experience and/or background are preferred.
- Research Nurse is expected to maintain nursing license, ACLS certification for RNs and a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices.
SPECIALIZED TRAINING/CERTIFICATES
- ACLS certification for RNs
- Basic Cardiac Life Support
COMPENTENCY REQUIREMENTS
- Excellent communication skills
- Critical thinking skills.
- Planning /Organizational Skills
- Personal Motivation
- Customer Service Skills
TECHNICAL COMPENTENCY REQUIREMENTS
- 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.
PHYSICAL REQUIREMENTS AND OR ENVIROMENTAL FACTORS
- 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.
About ACRS
American Clinical Research Services (ACRS) Holdings was founded to improve the quality of life for millions of Americans through scientific research. Given the challenges in patient recruiting and the increased complexity around clinical trials, ACRS is focused on the opportunity to achieve efficiencies in a highly fragmented sector.
All employees must be authorized to work in the United States. ACRS provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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