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Job Summary:

In addition to the responsibilities listed below, this position is also responsible for contributing to patient care management during clinical studies; preparing and administering medications as outlined in study protocols; ensuring accurate documentation from team members for care provided to patients; monitoring and reporting changes in patient condition; leveraging advanced knowledge to support medical operations and patient safety; and providing educational materials to patients and addressing patient questions.

Essential Responsibilities:

• 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.