Research Nurse 3 - Clinical Trials

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.

• 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.

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.

• 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.

• Bachelors degree in Nursing AND minimum two (2) years of experience in clinical health care or a directly related OR Associates degree in Nursing AND minimum four (4) years of experience in clinical health care or a directly related field.

• Registered Nurse License (California) required at hire

• Bachelors degree in Nursing AND minimum two (2) years of experience in clinical health care or a directly related OR Associates degree in Nursing AND minimum four (4) years of experience in clinical health care or a directly related field.

• Registered Nurse License (California) required at hire

• Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).
• Basic Life Support (BLS) Certification from the American Heart Association

• Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).
• Basic Life Support (BLS) Certification from the American Heart Association

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