Clinical Research Nurse I-III

This position will represent CRN interests with design and development projects for medical record templates, databases, SOP validation, treatment plan validation, and other projects as assigned by the CRN Team Lead. Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Will work closely with CRN Team Lead and CRAs to manage the day-to-day operations and objectives in support of assigned portfolio. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Directs participant care related to research assessments, measurements, investigational product administration, and collaborations with care team. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff. Conducts complex work important to the organization. Contributes to measurable team and/or organization objectives.

Responsibilities

• Coordinates screening, consenting, enrollment, treatment/observation, and follow-up of subjects in cancer trials.
• Ensures treating physicians and subjects proceed through treatment phases on schedule without deviation.
• Advises the PI on study and data collection requirements.
• Represents the department and investigators at local, regional, and national meetings.
• Facilitates effective communication among staff, PIs, research/clinical professionals, UAMS senior leaders, and study sponsors.
• Assists with developing, implementing, and maintaining quality assurance plans and develops SOPs as needed.
• Serves as the general administrator and liaison for the PI, research subjects, human-testing compliance, privacy/HIPAA compliance, research/clinical professionals, and the granting or funding entity related to the research protocol.
• Ensures strict adherence to all regulatory requirements, such as reporting serious adverse events within the timeline required by the study sponsor and the Institutional Review Board.
• Prepares high-quality written documents; analyzes data and formulates conclusions.
• Maintains accurate, up-to-date clinical and research documentation, as well as database information, for all assigned protocol subjects.
• Thoroughly evaluates patients for eligibility prior to enrollment.
• Conducts clinical-based review of systems at appropriate patient visits and ensures all study procedures are conducted per protocol-specific requirements.
• Provides extensive education to patients and their caregivers/families, works closely with patients’ local physicians, and assists physicians in patient management.
• Conducts necessary measures to ensure study subjects follow strict protocol compliance.
• Works with the CRN Team Lead and CRAs to collect and manage patient information.
• Ensures information provided to CRAs for data entry is complete and accurate and assists CRAs with query resolution and monitoring/auditing visits and responses.
• Provides training for staff and investigators.
• Develops and implements process improvements and participates in developing electronic infrastructure.
• Participates in ongoing professional training.
• May perform other duties as assigned.