Clinical Research Coordinator III, Clinical Trials

Job Summary:
Collects data for clinical trials research, independently. Prepares and/or supports the submission of study documentation to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of standard and non-standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions, with limited guidance. Learns about providing input on implementing budgeting components for internally funded standard and non-standard projects. Drafts and/or prepares and submits clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures. 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.

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)

• 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

Minimum Qualifications:

• 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.

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.

Primary Location: California,San Diego,Viewridge 1 Medical Offices
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon, Tue, Wed, Thu, Fri
Working Hours Start: 08:00 AM
Working Hours End: 05:00 PM
Job Schedule: Full-time
Job Type: Standard
Employee Status: Regular
Worker Location: Flexible
Employee Group/Union Affiliation: NUE-SCAL-01|NUE|Non Union Employee
Job Level: Individual Contributor
Department: Department of Research and Evaluation
Pay Range: $71000 - $91850 / year Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not reflect the full value of our total rewards package. Actual base pay determined at offer will be based on labor market data, internal alignment, and a candidate's years of relevant work experience, education, certifications, skills, and geographic location.
Travel: Yes, 50 % of the Time Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status. For jobs where work will be performed in unincorporated LA County, the employer provides the following statement in accordance with the Los Angeles County Fair Chance Ordinance. Criminal history may have a direct, adverse, and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment:

• Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente's Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state, and local laws and regulations, accreditation, and licensure requirements (where applicable), and Kaiser Permanente's policies and procedures.
• Models and reinforces ethical behavior in self and others in accordance with the Principles of Responsibility, adheres to organizational policies and guidelines; supports compliance initiatives; maintains confidences; admits mistakes; conducts business with honesty, shows consistency in words and actions; follows through on commitments.
• Job duties with at least occasional or possible access to: (1) patients, the general public, or other employees; (2) confidential protected health information and other confidential KP information (including employee, proprietary, financial or trade secret information); (3) KP property and assets, for example, electronic assets, medical instruments, or devices; (4) controlled substances regulated by federal law or potentially subject to diversion.