Clinical Research Licensed Practical Nurse Lpn H/F Biotrial

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.