Vice President, Enterprise Research Administration

The Vice President, Research Administration, is a national executive leader and will serve as Kaiser Permanente-s Institutional Official (IO), providing executive oversight and leadership for the administration, compliance, and financial management of clinical and translational research across all Kaiser Permanente markets. This role requires extensive knowledge of research regulatory frameworks, financial compliance, and the ability to collaborate with stakeholders at all levels of the organization to ensure the safe and efficient execution of research activities. The incumbent will also be responsible for the strategic oversight of Kaiser Permanente-s expanding clinical trials program, with a particular focus on enhancing system-wide collaboration in research. This includes fostering partnerships within Kaiser Permanente-s existing markets and with newly acquired organizations, such as those within Risant Health, to establish a robust clinical trials infrastructure across the health system. In addition to expanding clinical trials capacity, the incumbent will drive the development of strategic initiatives to improve clinical research compliance and financial transparency, ensuring Kaiser Permanente meets all regulatory, fiscal, and ethical standards in clinical and translational research.

• Assessment and Enhancement of Research Infrastructure: 
  • Lead comprehensive assessments of existing research infrastructure to identify gaps and investment needs required to support the efficient and compliant conduct of clinical trials research. This includes reviewing current capabilities, identifying emerging technologies (such as AI-based data analytics, cloud-based research platforms, and clinical trial management systems) that can enhance research workflows, and recommending improvements for streamlining clinical research processes.
  • Collaborate with investigators to ensure the development and deployment of enterprise-wide solutions that support multi-site and cross-regional clinical research.
• Expansion of KP Clinical Trials Program:
  • Partner with key clinical, operational, and research leaders to develop and implement a system-wide strategy for expanding Kaiser Permanente-s clinical trials program, with a focus on critical service lines such as oncology, cardiology, neurology, and orthopedics. This strategy will include standardizing research protocols, enhancing recruitment strategies, and establishing shared services to support the growth of clinical trial participation across multiple regions.
  • Lead efforts to expand Kaiser Permanente-s clinical trials participation and develop a sustainable model for integrating Risant Health-s affiliated health systems into the broader clinical trials network.
• Building Cross-Regional and Multi-Site Collaboration:
  • Facilitate the development of scalable infrastructure to support cross-regional and multi-site clinical trials, including establishing shared research platforms, centralized research coordination teams, and uniform trial management practices that streamline study initiation and enrollment across regions.
  • Foster external collaborations with academic research institutions, pharmaceutical companies, and regulatory agencies to expand research opportunities and enhance clinical trial outcomes.
• Leadership of Clinical Trials Management System (CTMS) Deployment:
  • Provide strategic oversight for the deployment, enhancement, and optimization of the Clinical Trials Management System (CTMS) across all Kaiser Permanente markets. This system will enable real-time tracking of research activities, improve trial monitoring, facilitate data management, and enhance the reporting of clinical trial outcomes.
  • Ensure that the CTMS platform aligns with regulatory standards and supports streamlined data capture, compliance, and financial management across trials.
• Compliance Oversight and Regulatory Leadership:
  • Serve as the Institutional Official (IO) for Kaiser Permanente, holding primary responsibility for the institution-s adherence to all federal, state, and institutional regulations related to human subject research protections, including compliance with IRB (Institutional Review Board) guidelines and Good Clinical Practice (GCP) standards.
  • Oversee compliance with the Office of Management and Budget (OMB) regulations concerning federal research funding, ensuring appropriate fiscal stewardship and adherence to cost allocation principles.
  • Ensure compliance with Sarbanes-Oxley (SOX) and Medicare regulations, particularly related to the financial oversight of research grants, contracts, and external partnerships.
• Risk Management and Ethical Oversight:
  • Chair the Institutional Risk Committee, responsible for identifying, assessing, and mitigating risks associated with clinical and translational research. This includes ensuring ethical research practices, managing potential conflicts of interest, and overseeing the resolution of compliance or financial discrepancies within clinical trials.
  • Develop and implement corrective action plans for any research compliance deficiencies, working with leadership to monitor progress and ensure alignment with best practices and regulatory standards.
• Human Research Protection Program (HRPP) Training and Quality Assurance:
  • Oversee the Human Research Protection Program, ensuring that training, quality assurance programs, and audits are aligned with current federal regulations and industry standards. This includes expanding HRPP training to incorporate new research technologies, telemedicine-based trials, and other innovative approaches to clinical trial design.
  • Ensure that all research staff are equipped with the knowledge and tools necessary to maintain the highest levels of compliance and ethical conduct throughout the research lifecycle.
• Good Clinical Practice (GCP) Program and Quality Assurance:
  • Oversee the GCP Program, ensuring that training, quality assurance programs, and audits are aligned with current federal regulations and industry standards. This includes expanding GCP training for research principal investigators to incorporate new research technologies, telemedicine-based trials, and other innovative approaches to clinical trial design.
  • Ensure that all research staff are equipped with the knowledge and tools necessary to maintain the highest levels of compliance and ethical conduct throughout the research lifecycle.
• Financial and Resource Management:
  • Oversee the strategic allocation of research funding, ensuring that financial resources are optimally deployed to support priority areas such as clinical trials, infrastructure improvements, and personnel development. Monitor research budgets, ensuring cost efficiency, accurate financial reporting, and compliance with grant and contract requirements.
  • Provide oversight for the Kaiser Foundation Research Institute (KFRI), which is responsible for the execution of the organization-s financial, regulatory, and administrative functions related to research. This includes ensuring the timely submission of financial reports to funding agencies and internal stakeholders.
• Strategic Communication and Reporting:
  • Regularly report to Kaiser Permanentes executive leadership on the status and progress of clinical trials research programs. Provide insights on research outcomes, areas for improvement, and the financial health of research activities.
  • Serve as a spokesperson for Kaiser Permanente-s research excellence, engaging with external stakeholders, including federal agencies, industry partners, and academic collaborators, to promote the organization-s research capabilities and achievements. 

Qualifications:

• Minimum seven (7) years experience in research administration, clinical trials management, and compliance in a large-scale, multi-site healthcare environment.

• An advanced degree in a relevant field (e.g., medicine, nursing, public health, biomedical sciences, healthcare administration, medical education).

• N/A

• Deep knowledge of federal research regulations (e.g., 45 CFR 46, FDA regulations, OMB Circulars, Sarbanes-Oxley), as well as clinical trial protocols, IRB processes, and GCP.
• Expertise in financial management for clinical research, including budgeting, cost analysis, and reporting for federal grants, pharmaceutical partnerships, and other funding sources.

• Strong communication skills to interact with stakeholders at all levels, including clinical, research, legal, financial, and executive leadership.
• Proven leadership skills in managing large, cross-functional teams, with a focus on building a culture of compliance and ethical conduct in clinical research.