Coordinates the compliant implementation and conduct of human subject research projects, utilizing the nursing process, typically of low to medium workload and low to medium complexity.

RESPONSIBILITIES:

• Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements, including timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of serious adverse events as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
• Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
• Utilizes the nursing process as a basis for patient care.
• Assesses research subject; completes nursing assessment, documenting findings in research subject records and notifies physician of abnormal findings.
• Establishes a care plan in collaboration with the research subject, family and research team. Coordinates ongoing care.
• Identifies discharge needs and facilitates discharge planning as appropriate.
• Performs telephone triage.
• Performs nursing procedures and treatments as directed by physician or LIP in the treatment and management of patient care.
• Evaluates, initiates and maintains standards of care consistent with policies and procedures.
• Assists with specialized patient care equipment as required by the clinical research protocol.
• Administers medications and treatments as ordered by a physician or LIP.
• Directs, coordinates and participates in the evaluation and supervision of nursing care provided to research subjects, establishing patient care priorities and delegating nursing activities according to the patient needs and staff qualifications and capabilities.
• Participates in education, research and performance improvement activities.
• Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.
• Assists with preparation for audits and response to audits.
• Maintains professional relationships, using frequent and open effective communication with internal and external constituents.
• Assists with the development of training and educational material for assigned research protocols.
• Provides and documents education as needed.
• Conducts and documents the informed consent process.
• Assists with research project budget development.
• Other duties as assigned.