PLEASE NOTE: This position will require working onsite 4 days a week (5 days a week for the first few months) Job
In addition to the responsibilities listed below, this position is also responsible for contributing to patient care management during clinical studies; preparing and administering medications as outlined in study protocols; documenting care provided to patients; monitoring and reporting changes in patient condition; leveraging comprehensive knowledge to support medical operations and patient safety; and providing educational materials to patients.
Essential
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.
Qualifications 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 Ethics Stakeholder Management Survey Methodology The Scientific Method
Bachelors degree in Science, Public Health, Health Care Administration, or related field AND minimum two (2) years of experience in clinical research or a directly related field OR Minimum five (5) years of experience in clinical research or a directly related field. Vocational 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. Scheduled Weekly Hours: 40
Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 08:30 AM Working Hours End: 05:00 PM Job
Full-time Job Type: Standard Worker Location: Flexible Employee Status: Regular Employee Group/Union Affiliation: NUE-SCAL-01|NUE|Non Union Employee Job Level: Individual Contributor Department: Department of Research and Evaluation
$71000 - $91850 / year Travel: Yes, 10 % of the Time Flexible: Work location is on-site at a KP location, with the flexibility to work from home.