Clinical Research Coordinator II, Clinical Trials-Santa Clara

Job Summary

Collects data for clinical trials research, following general directions. Supports the preparation of study documentation for submission 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), with limited guidance. Assists with the development and/or implementation of 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 standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance. Learns about providing input on implementing budgeting components for internally funded standard projects. Learns to draft and submit clinical trials applications, under guidance, 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 sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback. Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work. Assesses and responds to the needs of others to support a business outcome. Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship. Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports the completion of priorities, deadlines, and expectations. Identifies and speaks up for ways to address improvement opportunities.
• Assists in budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard projects.
• Conducts clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of clinical trials, studies, and interventions at the site-level; contributing to the development of standard clinical research protocols and other processes of clinical trials with limited guidance; supporting the preparation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing 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 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.