Clinical Research Nurse

24 hours ago

Montclair, New Jersey, United States ACRS Holdings Full time
Job Title: Clinical Licensed Vocational Nurse

Catalina Research Institute (CRI), an ACRS company, is a leading provider of Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a skilled Licensed Vocational Nurse (LVN) to join our team.

Job Summary:

The Clinical Licensed Vocational Nurse will provide nursing standard of care in a research environment, monitoring study participants, 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.

Responsibilities:
  • Obtains, processes, and ships laboratory samples as per protocol.
  • Assists and supports 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.
  • Assesses adverse events and drug reactions – seeks medical intervention for patients when appropriate.
  • Reports 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.
  • Performs all protocol-related procedures, including vital signs, ECGs, phlebotomy, finger sticks, mouth swabs, spirometry, urine dipsticks, drug screens, pregnancy tests, etc.
  • Adequately documents study procedure collection via progress notes, adverse event information observed and/or reported along with procedures performed during clinical trial.
  • Obtains lab reports, procedure reports, and ensures investigator reviews all lab results in form of full signature along with providing clinical significance to any out of range and/or abnormal value.
  • Dispenses and monitors allowed concomitant medication intake.
  • Dispenses and monitors 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.
  • Attends Site initiation visits and/or training in-service for all protocols.
  • Maintains current Safe-t-pack biohazard training certification or IATA equivalent, (ACLS) advance life support certification, OSHA, and site's SOP (SWP) training.
  • Has 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.
Requirements:
  • 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.
Competency Requirements:
  • Excellent communication skills.
  • Critical thinking skills.
  • Planning/Organizational Skills.
  • Personal Motivation.
  • Customer Service Skills.
  • Technical Competency 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 Environmental 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 Holdings:

Established in 2022 through the acquisition of Catalina Research Institute, a leader in therapeutically focused clinical research, ACRS has positioned itself as a significant player in the industry.

Building on this foundation, ACRS strengthened its services in 2023, acquiring CSSi and Patient Advertising Guru, both prominent companies specializing in patient recruitment.

The culmination of these strategic acquisitions is the recent addition of Elixia, whose name will now be adopted for the entire organization.

The company remains committed to its partners, patients, and stakeholders as it embarks on this exciting new chapter.

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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