Clinical Research Licensed Practical Nurse (LPN)

Biotrial; Newark, Northern (NJ, KY); Hybrid; USD 66,000 - 85,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Health insurance

Paid time off

Referral program

Vision insurance

Job summary

Biotrial, a leading CRO, seeks a Clinical Research Licensed Practical Nurse (LPN) to join our team in New Jersey. The role focuses on protocol adherence, data integrity, and direct study procedures under supervision, including infusions and specimen collection.

Candidates should hold an active NJ LPN license with at least 3 years of LPN experience, familiarity with HIPAA and clinical research regulations, and strong communication skills. Proficiency with MS Office is expected.

Qualifications

• Active LPN license in New Jersey as required for this role.
• Minimum of 3 years' LPN experience in clinical settings.
• Familiarity with HIPAA regulations and study protocols.
• Knowledge of FDA regulatory requirements (CITI) preferred.
• Excellent verbal and written communication skills.
• Proficiency with MS Office applications (Word/Excel).

Responsibilities

• Develop familiarity with the study protocol and flow chart of procedures.
• Implement procedures per protocol and HIPAA guidelines.
• Review and validate study CRFs with investigators and team.
• Perform study procedures including infusions, IVs, venipunctures, and specimen collection.
• Document data in source documents and relay data for CRFs.
• Assist adverse event reporting to sponsor as required.
• Maintain independent, accurate, efficient work with high productivity.

Skills

LPN license NJ

IV experience

3+ years LPN experience

HIPAA knowledge

FDA regulatory knowledge (CITI)

Strong communication

MS Office proficiency

Tools

Microsoft Word

Microsoft Excel

Job description

Clinical Research Licensed Practical Nurse (LPN)

• 66000 - 85000 USD / an

Responsibilities:

• Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.
• Implement study procedures in compliance with accepted research guidelines including Health Insurance Portability and Accountability Act (HIPAA) regulations and the study protocol.
• Participate in the review and validation of the study CRFs in conjunction with the Investigator, Clinical Research Nurse, and the Clinical Research Associate of the Study.
• Perform study procedures (e.g., participate in screening procedures, prepare and administer infusions under the supervision of a pharmacist or physician, start intravenous lines, venipunctures, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, etc., and pharmacodynamic measures - psychometric tests, etc.), process blood samples as required by study protocol under the supervision of the Principal Investigator.
• Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness.
• Assist in transcribing study data from source documents to sponsor designated case report forms or record data for remote data entry if applicable.
• Resolve data queries in conjunction with the sponsor.
• Assist the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
• An active LPN license in the State of New Jersey and IV experience preferred, but not required.
• Minimum of 3 years' experience as a LPN.
• Knowledge of FDA regulatory requirements is necessary, ex. CITI
• Excellent communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, Biotrial Clinical Project Team and Sponsor personnel.
• Excellent communications skills with ability to interact with Sub-Investigators, Project Team and Sponsors.
• Good working knowledge of Microsoft Office Suite including Word and Excel.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to speak effectively before sponsors, patients and employees of organization.
• Knowledgeable of clinical research process preferred but not required.
• Ability to work independently, efficiently and accurately with high productivity.
• Experience in conducting complex long-term projects and meeting strict timelines.
• Good interpersonal skills.

Biotrial is a leading CRO specializing in Drug Development with a wide range of expertise in preclinical pharmacology, clinical development, bioanalysis, biometrics and ECG, CNS and Imaging Core Lab. With over 35 years of experience in providing scientific and medical services in clinical development, Biotrial offers innovative, tailor-made solutions to Biotech and Pharmaceutical companies.

Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off
• Referral program
• Vision insurance