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Job description
Job Summary:
In addition to the responsibilities listed below, this position is also responsible for leveraging clinical research expertise and leadership in all aspects of nursing practice; participating in the implementation of new protocols; administering research interventions; evaluating the patient-s 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; independently providing nursing care, clinical oversight and judgement of research activities within scope of practice, and delegating activities as appropriate; identifying and 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 driving quality improvement activities in the team or program of care level.
Essential Responsibilities:
Promotes learning in others by proactively providing and/or developing information, resources, advice, and expertise with coworkers and members; builds relationships with cross-functional/external stakeholders and customers. Listens to, seeks, and addresses performance feedback; proactively provides actionable feedback to others and to managers. Pursues self-development; creates and executes plans to capitalize on strengths and develop weaknesses; leads by influencing others through technical explanations and examples and provides options and recommendations. Adopts new responsibilities; adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; champions change and helps others adapt to new tasks and processes. Facilitates team collaboration to support a business outcome.
Completes work assignments autonomously and supports business-specific projects by applying expertise in subject area and business knowledge to generate creative solutions; encourages team members to adapt to and follow all procedures and policies. Collaborates cross-functionally and/or externally to achieve effective business decisions; provides recommendations and solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Supports the development of work plans to meet business priorities and deadlines; identifies resources to accomplish priorities and deadlines. Identifies, speaks up, and capitalizes on improvement opportunities across teams; uses influence to guide others and engages stakeholders to achieve appropriate solutions.
Works on budgeting and financing by: contributing to drafting proposals for large-scale contracts, including reviewing and summarizing literature; and helping support the development and justification of budgets for internally and externally funded complex projects.
Conducts and leads clinical research by: reviewing, designing, and collecting clinical trials data; leveraging an advanced knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging advanced knowledge when providing input on the design of clinical trials, studies, and interventions at the site-level; developing innovative clinical research protocols and other processes of large-scale clinical trials; preparing, submitting, and/or collaborating with others to ensure correct compilation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing 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 various 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).
Facilitates research compliance by: providing subject-matter advice for clinical trial applications to ensure 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 developing corrective action plans, escalating as necessary; developing and implementing updates for compliance-monitoring/audit systems and documentation; contributing to the implementation and development of advanced approaches to analyze risk-management data and making recommendations to mitigate potential risk; driving the implementation of research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging in-depth 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 advanced knowledge of how to lead research stakeholders and investigators in various research projects; serving as a point of contact for key project contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for educating staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions.
Ensures documentation of clinical research files by: ensuring the timely, accurate, and complete documentation of all research activities (e.g., consent forms, reports, tracking forms); contributing to the development and/or implementation of moderately complex quality control and/or assurance measures and providing feedback to research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials, escalating when necessary; and monitoring and auditing Clinical Trials across sites and presenting findings to KP leadership.
Knowledge, Skills and Abilities: (Core)
Ambiguity/Uncertainty Management
Attention to Detail
Business Knowledge
Communication
Critical Thinking
Cross-Group Collaboration
Decision Making
Dependability
Diversity, Equity, and Inclusion Support
Drives Results
Facilitation Skills
Health Care Industry
Influencing Others
Integrity
Learning Agility
Organizational Savvy
Problem Solving
Short- and Long-term Learning & Recall
Teamwork
Topic-Specific Communication
Knowledge, Skills and Abilities: (Functional)
Employee/Labor Relations
Health Care Operations
Nursing Principles
Regulatory Agencies
Research Databases
Accountability
Adaptability
Autonomy
Business Relationship Management
Clinical Research
Clinical Research Quality
Compliance
Computer Literacy
Data Quality
Experimental Design
Innovative Mindset
Laboratory Equipment
Laboratory Procedures
Managing Diverse Relationships
Organizational Skills
Project Management
Project Management Tools
Quality Assurance Process
Quantitative Research Methods
Research EthicsStakeholder Management
Survey Methodology
The Scientific Method
Minimum Qualifications:
Bachelors degree in Nursing AND minimum four (4) years of experience in clinical health care or a directly related OR Associates degree in Nursing AND minimum six (6) years of experience in clinical health care or a directly related field.
Minimum one (1) year of experience in a leadership role with or without direct reports.
Registered Nurse License (California) required at hire
Preferred Qualifications:
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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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.