Primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and patients. Position includes disseminating information to CRN's on the unit regarding new information for documentation, performance improvement and PIMS upgrades. Provide study support as assigned within a defined scope to include managers, clinical research nurse coordinators (CRNC), investigators and sub-investigators, unit personnel, and other ancillary staff.

Responsibilities

• Facilitate and participate in the execution of study-related activities of a Phase I clinical research study conducted at the Phase I Unit in relation to areas of responsibility. Maintain safety and confidentiality of study subjects throughout the study. Evaluate adverse events and manage safety reporting activities in a timely manner. Review protocols and informed consent forms for scheduled studies. Identify and communicate potential issues to the appropriate personnel.
• Conduct nursing study related activities as required by protocol in compliance with corporate, divisional, and department SOP’s and external (CFR, ICH, GCP) regulatory guidelines. Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel to organize study-specific nursing activities.
• Participate in quality and compliance improvement initiatives and provide feedback as a nursing subject matter expert. Maintain accurate and complete source data in PIMS and/or other source documents and facilitate the resolution of source discrepancies or issues, as appropriate.
• Assist with protocol-specific training for study personnel in preparation for study activities. Facilitate training of new nursing personnel and ensure management is apprised of trainee progress. Recognize and implement changes to the activity schedule based on the strategic plan. Assists with the Informed Consent process for all study subjects.
• Assists with the resolution of study related questions and/or mitigate issues in conjunction with appropriate clinical research personnel. Assists with maintaining study forms/tools to facilitate accurate tracking and documentation of relevant study information.
• Ability to provide guidance or direction for protocol related activities. Identifies situations that require further intervention and escalates appropriately. Ability to perform multiple concurrent tasks with occasional interruptions required.
• Trains and participates in trial related activity from the initial entry to complete follow-up of patients enrolled into research protocols. Shares knowledge and expertise through educating team members. Provides training on revised and/or updated processes and updates nursing staff accordingly. Develops training documents (powerpoint, etc). Provides in-servicing and educating both the nursing units and lab staff regarding upcoming and ongoing protocols.
• Reports adverse drug reactions and submits the appropriate documentation.
• Provide direct care to research patients, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects. Ability to exercise discretion and confidentiality while handling sensitive situations required.
• Ability to provide direct patient care in a professional and respectful manner required. Knowledge of patient care fundamentals, including aseptic principles and techniques required. Ability to read documents or instruments required.