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.
Required Minimum Education:
MD or DO
Required Minimum Work Experience and Qualifications:
Demonstrated expertise in and experience in leading and managing clinical trials research
Demonstrated ability to effectively facilitate interdisciplinary teams
Prior leadership experience managing and leading clinical trials teams
Not prohibited from research by any government agency
Familiarity with investigator-initiated research including IND/IDE and related FDA requirements
Preferred Work Experience and Qualifications:
A minimum of 5 years of prior clinical trials experience preferred
Preferred Licensure, Certification, Registration or Designation:
Active medical license and board certification in medical specialty
SOCRA training and certification (CCRP) obtained within one (1) year of hire
All qualified applicants who apply for an open position will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, sexual orientation, gender identity, protected veteran status, marital status, physical or mental disability, age, or any other protected status under federal, state or local law.
CPMG is a physician-led organization that has pioneered the integrated health model in Colorado since 1969. We exclusively partner with Kaiser Foundation Health Plan of Colorado and share the same mission — to provide high-quality, affordable health care services and improve the health of our patients and the communities we serve.