Clinical Research Coordinator III, Clinical Trials, Vaccine Research; Durational

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.

• 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…