Clinical Research Coordinator I, Clinical Trials

Collects data for clinical trials research, with guidance. May support clinical trials activities and research lab operations. Supports the timely, accurate, and complete documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of routine quality control and/or assurance measures and documents feedback to research staff and management, as instructed. Supports the education of research staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance. Learns about the budgeting process. Learns to document clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.

• Pursues effective relationships with others by sharing information with coworkers and members. Listens to and addresses performance feedback. Pursues self-development; acknowledges strengths and weaknesses, and takes action. Adapts to and learns from change, challenges, and feedback. Responds to the needs of others to support a business outcome.


• Completes routine work assignments by following procedures and policies and using data, and resources with oversight and management. Collaborates with others to address business problems; escalates issues or risks as appropriate; communicates progress and information. Adheres to established priorities, deadlines, and expectations. Identifies and speaks up for improvement opportunities.


• Assists in budgeting and financing by: learning about the budgeting process.


• Assists with clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) with substantial guidance; developing a basic understanding of source data and the tools leveraged to analyze clinical data; developing a basic understanding of clinical trials, studies, and interventions at the site-level; following detailed instructions while contributing to the development of routine clinical research protocols and other processes of clinical trials; understanding study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for supporting or executing basic 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 basic 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), with guidance.


• Learns about research compliance by: learning to document clinical trial applications and relevant data in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; learning the fundamentals of compliance and quality including issue identification and resolution; performing quality assurance checks/audits on compliance-monitoring/audit systems and documentation, escalating when necessary; learning to and performing data entry tasks with guidance from a supervisor to assist with risk-management; learning about and implementing the research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with guidance; and leveraging basic research expertise to supplement the guidance provided to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.


• Learns to maintain internal and external effective working relationships by: developing a basic knowledge about important research stakeholders and projects; communicating, under guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and learning to develop materials to support the education of staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance.


• Ensures documentation of clinical research files by: supporting the documentation of all research activities (e.g., consent forms, reports, tracking forms) under close monitoring on a routine basis; assisting with the development of routine quality control and/or assurance measures and documenting feedback for the research staff and management as instructed; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard protocols and processes; and developing an understanding of how to monitor and audit Clinical Trials as well as documenting findings.