Clinical Research Coordinator IV, Infectious Disease, Hepatology and Vaccine Clinical Trials (Durational with Benefits)

Collects data and reviews and designs data collection for clinical trials research. Prepares, submits and/or collaborates with others to ensure correct compilation of study documentation is sent to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Ensures the timely and accurate documentation of all research activities (e.g., consent forms, reports). Contributes to the development and/or implementation of moderately complex quality control and/or assurance measures and provides feedback to research staff and management. Develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions. Contributes to proposal drafting for large-scale contracts and helps support the development and justification of internally and externally funded project budgets. Provides subject-matter advice for clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.

• Promotes learning in others by proactively providing and/or developing information, resources, advice, and expertise with coworkers and members; builds relationships with cross-functional/external stakeholders and customers. Listens to, seeks, and addresses performance feedback; proactively provides actionable feedback to others and to managers. Pursues self-development; creates and executes plans to capitalize on strengths and develop weaknesses; leads by influencing others through technical explanations and examples and provides options and recommendations. Adopts new responsibilities; adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; champions change and helps others adapt to new tasks and processes. Facilitates team collaboration to support a business outcome.


• Completes work assignments autonomously and supports business-specific projects by applying expertise in subject area and business knowledge to generate creative solutions; encourages team members to adapt to and follow all procedures and policies. Collaborates cross-functionally and/or externally to achieve effective business decisions; provides recommendations and solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Supports the development of work plans to meet business priorities and deadlines; identifies resources to accomplish priorities and deadlines. Identifies, speaks up, and capitalizes on improvement opportunities across teams; uses influence to guide others and engages stakeholders to achieve appropriate solutions.


• Works on budgeting and financing by: contributing to drafting proposals for large-scale contracts, including reviewing and summarizing literature; and helping support the development and justification of budgets for internally and externally funded complex projects.


• Conducts and leads clinical research by: reviewing, designing, and collecting clinical trials data; leveraging an advanced knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging advanced knowledge when providing input on the design of clinical trials, studies, and interventions at the site-level; developing innovative clinical research protocols and other processes of large-scale clinical trials; preparing, submitting, and/or collaborating with others to ensure correct compilation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing 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 various 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).


• Facilitates research compliance by: providing subject-matter advice for clinical trial applications to ensure 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 developing corrective action plans, escalating as necessary; developing and implementing updates for compliance-monitoring/audit systems and documentation; contributing to the implementation and development of advanced approaches to analyze risk-management data and making recommendations to mitigate potential risk; driving the implementation of research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging in-depth 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 advanced knowledge of how to lead research stakeholders and investigators in various research projects; serving as a point of contact for key project contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for educating staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions.


• Ensures documentation of clinical research files by: ensuring the timely, accurate, and complete documentation of all research activities (e.g., consent forms, reports, tracking forms); contributing to the development and/or implementation of moderately complex quality control and/or assurance measures and providing feedback to research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials, escalating when necessary; and monitoring and auditing Clinical Trials across sites and presenting findings to KP leadership.