Job Summary: 

The Medical Director of Clinical Trials will report to the Executive Director of the Institute for Health Research (IHR) and will ensure that KPCO clinical research reflects the highest standards of scientific excellence and ethical conduct for the protection of human subjects.  The incumbent will review matters pertaining to the provision of patient care to KPCO members in clinical trials research protocols, both within KPCO and at outside institutions, and oversee research resource stewardship.  The Clinical Trials Medical Director will provide leadership to clinician investigators in all aspects of clinical trial engagement with a view toward producing an integrated, cost effective, and strategic clinical trials portfolio for the Kaiser Permanente Colorado Membership.   The Clinical Trials Medical Director will engage in the development of new clinical investigators by ensuring appropriate mentoring and education. The incumbent will guide the review, selection and development of trials, consistent with the strategic plan and direction that is developed as part of their leadership and in consultation with IHR, Kaiser Foundation Health Plan and Colorado Permanente Medical Group (CPMG) leadership. The position will work closely with Clinical Trials Health Plan Leadership as well as supporting the Clinical Trials Administration in audits, compliance, review of Standard Operating Procedures (SOPs), and management of clinician accruals.

Major Responsibilities/Essential Functions: 

• Supervises clinician investigators including monitoring and management of accruals, engagement, compliance with Good Clinical Practice (GCP) and regulatory requirements, protection of human subjects and conflicts of interest
• Develops new investigators by providing mentoring and ensuring appropriate education and training.
• Collaborates with clinician investigators in the development and funding of investigator-initiated protocols
• Advocates for clinical trials within KPCO, including presenting to Health Plan and CPMG leaders about clinical trials
• Serves as an information resource for CPMG physicians inquiring about clinical trials for patients
• Secures CPMG board approval for studies when needed
• In collaboration with appropriate departments, develops a clinical case management and resource utilization review process for patients on clinical trials outside KP and works with the referring physician/designated physician to ensure appropriate utilization of resources and compliance with KP resource stewardship, KP standards, Medicare, FDA rules and applicable laws
• Consults with the Clinical Trials (Health Plan) leadership in trial selection, audits, Human Subjects Protection, regulatory documentation, SOPs, analysis of protocol violations and unanticipated events, and accrual management
• Supervises Clinical Trials staff
• Supports Clinical Trials coordinators and regulatory staff by providing medical expertise
• Available to IRB for Clinical Trials questions during relevant reviews
• Collaborates in the review of study protocols for suitability, feasibility, appropriateness, and PI engagement
• Attends Medical Science Liaison (MSL) and pharmaceutical sponsor meetings as required by KP (SOPs)
• Reviews and assesses Principal Investigator determination of serious adverse events and unanticipated events
• Assists in the development of relevant Corrective Action and Preventive Action (CAPA) plans prior to submission
• Interfaces with multiple clinical departments to facilitate clinical trials objectives
• Collaborates with relevant internal stakeholders such as Compliance and Resource Stewardship
• Develops relationships with community and KP clinical trials network partners in the other KP regions
• Required attendance at critical meetings related to this role
• Oversight and knowledge of regulatory and compliance issues related to the conduct of clinical trials

FTE: 0.6 administrative time dedicated to Medical Director of Clinical Trials responsibilities; the remaining 0.4 FTE may consist of clinical care delivery within KPCO and/or research activities at KPCO supported by external funding.