Day LPN

IQVIA•Fairfax, VA

About The Position

Support study sites in coordinating Phase I–IV clinical research studies and ensure studies are conducted according to protocol, standard operating procedures, Good Clinical Practice (GCP), and other applicable guidelines and regulations. The role coordinates studies conducted by a supervising principal investigator and helps safeguard volunteer well-being while maintaining high standards of care and safety. The LPN supports study preparation and conduct, volunteer recruitment and screening, clinical procedures, study-drug administration and custody, and the collection and reporting of clinical data. The role also works with the study team, investigators, and monitors to resolve issues, support data quality, and report relevant adverse events.

Requirements

At least 1 year of relevant experience, or an equivalent combination of education, training, and experience.
Good knowledge of clinical trials.
In-depth knowledge of Good Clinical Practice (GCP) principles.
Skill using MS Windows and Office applications.
Effective written and verbal communication skills, including good command of English.
Excellent interpersonal and problem-solving skills.
Effective organizational skills and 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 where the site is located.

Responsibilities

Coordinate clinical research studies conducted by a supervising principal investigator.
Maintain current nursing skills, training, and knowledge of best practices and clinical research topics.
Safeguard the well-being of study subjects and maintain high standards of care.
Maintain a safe environment in accordance with health and safety policies.
Act as a volunteer advocate and respond proactively to volunteer and visitor concerns, taking remedial action as needed.
Assist registered and unregistered staff with nursing practices and delivery of care to volunteers.
Report deviations from normal practice to senior staff.
Review study protocols, case report forms, study documents, and electronic data capture systems.
Participate in project meetings and team huddles as needed.
Prepare for studies by labeling specimen containers, setting up equipment and documents, planning protocol procedures, preparing volunteer instructions, and obtaining required supplies and equipment.
Prepare and deliver study-specific training materials, documents, and records.
Troubleshoot study issues and help ensure assigned daily tasks meet expected standards.
Assist with data-quality checks and query resolution to ensure data adheres to the protocol and is accurate and complete.
Recruit and screen volunteers against predetermined inclusion criteria.
Orient volunteers to the study and site, including the study purpose, procedures, and visit timelines.
Administer and maintain custody of study drugs according to site standard operating procedures.
Perform clinical procedures, including ECGs, specimen collection and phlebotomy, spirometry, vital signs, cannulation, and cardiac telemetry monitoring.
Collect, record, and report clinical data and findings in case report forms.
Collaborate with the study investigator and report relevant adverse events and serious adverse events according to protocol procedures.
Cooperate with study monitors and reserve sufficient time to answer monitoring questions.