Day LPN

Job Overview

Support study sites in the coordination of Phase I-IV clinical research studies, ensuring that studies are carried out according to protocol, standard operating procedures, GCP, and other applicable guidelines and regulations.

Essential Functions

• Coordinate clinical research studies conducted by a supervising principal investigator.
• Update and maintain skills, training and knowledge of current best nursing practice and topics related to clinical research.
• Safeguard the well-being of the subjects and ensure and maintain high standards.
• Maintain a safe environment in accordance with the Health and Safety policies.
• Act as volunteer advocate.
• Deal with volunteer and visitor concerns in a pro-active manner and take remedial action as required.
• Assist staff, both registered and unregistered, in Nursing Practices and the delivery of care to the volunteer.
• Report any deviation from normal practice to senior staff.
• Review the study protocol, case report form (CRF), other study documents, and electronic data capture systems.
• Participate in project meetings with the project team as needed.
• Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents.
• Plan logistical activity for procedures as per protocol.
• Generate volunteer instructions.
• Identify and obtain required supplies and equipment.
• Prepare and deliver study specific training materials, documents, and records.
• Troubleshoot study issues.
• Participate in huddles to ensure daily tasks assigned to team members are executed to the expected standards.
• Assist with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness.
• Recruit and screen volunteers for inclusion in study based on pre-determined criteria.
• Orientate volunteers to the study and the site including the purpose of the study, procedures and practical issues such as timelines for visits.
• Responsible for the correct administration and custody of study drug according to site standard operating procedures.
• Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including phlebotomy, spirometry, vital signs, cannulation, and cardiac telemetry monitoring.
• Collect, record, and report clinical data and findings appropriately in case report forms (CRFs). Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
• Cooperate with study monitor and reserve sufficient time for questions during monitoring.

Qualifications

• 1 year relevant experience.
• Or equivalent combination of education, training and experience.
• Good knowledge of clinical trials.
• In-depth knowledge of the principles of Good Clinical Practices (GCP).
• Good skill in using MS Windows and Office applications.
• Effective written and verbal communication skills including good command of the English language.
• Excellent interpersonal skills.
• Excellent problem-solving skills.
• Effective organizational skills.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Current active nursing license in the state, country, or region in which the site resides.