Research Nurse III, RN, Clinical Trials

Job Summary:

In addition to the responsibilities listed below, this position is also responsible for leveraging comprehensive foundational clinical research knowledge in all aspects of nursing practice; participating in the implementation of new protocols; administering standard and nonstandard research interventions; evaluating the patients response to therapy; responding to variances in protocol implementation and reporting variances to the research team; integrating evidence-based practice into nursing practice and evaluating patient outcomes; providing nursing care and judgement of research activities within scope of practice; communicating the impact of the research process on patient care; adjusting interventions based on findings; collaborating with the interdisciplinary team and institutional leaders on improvement activities related to promoting patient/participant safety, clinical quality and reducing risk; and implementing quality improvement activities in the team or program of care level.

Essential Responsibilities:

• Pursues effective relationships with others by proactively providing resources, information, advice, and expertise with coworkers and members. Listens to, seeks, and addresses performance feedback; provides mentoring to team members. Pursues self-development; creates plans and takes action to capitalize on strengths and develop weaknesses; influences others through technical explanations and examples. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; helps others adapt to new tasks and processes. Supports and responds to the needs of others to support a business outcome.
• Completes work assignments autonomously by applying up-to-date expertise in subject area to generate creative solutions; ensures all procedures and policies are followed; leverages an understanding of data and resources to support projects or initiatives. Collaborates cross-functionally to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports, identifies, and monitors priorities, deadlines, and expectations. Identifies, speaks up, and implements ways to address improvement opportunities for team.
• Works on budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard and nonstandard projects.
• Conducts clinical research by: independently collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments); leveraging a comprehensive foundational knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging a comprehensive foundational knowledge of clinical trials, studies, and interventions at the site-level; independently contributing to the development of standard and nonstandard clinical research protocols and other processes of clinical trials; preparing and/or supporting the submission of study documentation to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing standard and non-standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard and non-standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).
• Ensures research compliance by: independently drafting and/or preparing and submitting clinical trial applications in compliance and consistency with all applicable federal, state, and local regulations, and reviewing and providing input on KP compliance policies and procedures; identifying compliance and/or quality issues and assisting in the development of corrective action plans, escalating as necessary; identifying opportunities to update compliance-monitoring/audit systems and documentation; utilizing standard approaches to analyze risk-management data and making recommendations to mitigate potential risk; independently implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging comprehensive research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.
• Maintains internal and external effective working relationships by: leveraging a comprehensive foundational knowledge of how to partner with research stakeholders and investigators within and across units to contribute to research projects; independently communicating with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions with limited guidance.
• Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) in a timely and accurate manner; assisting with the development and/or implementation of standard and nonstandard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a comprehensive foundational knowledge of how to monitor and audit Clinical Trials as well as documenting findings.