The Executive Director of the Samuel Oschin Comprehensive Cancer Institute (SOCCI) Clinical Trials Office(CTO) is accountable for providing strategic leadership, administrative and fiscal oversight of the clinical operations of the SOCCI CTO and activities relevant to the clinical research efforts in the SOCCI to include all clinical, administrative, personnel, regulatory compliance, and financial functions and the management of the expansion of clinical trials activities to satellite sites and affiliates. S/he directs managers/supervisors assigned to the various units within the CTO by establishing and implementing operational standards and monitoring progress and compliance. S/he serves as the subject matter expert on best practices on clinical trial management and on regulatory requirements. S/he is accountable for the strategic growth and continued success of the SOCCI CTO, in collaboration with the Associate Director for Clinical Research and the CRO Medical Director. This position reports to the Vice President of Operations for Cedars-Sinai and works collaboratively to develop, implement, and maintain the infrastructure necessary to support National Cancer Institute (NCI) designation.
Responsible for the strategic planning, organizing, and oversight of the SOCCI CTO including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement. Incumbent will ensure the development of SOCCI's clinical trial infrastructure that supports the clinical research community and is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines. Ensures that all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all research programs within SOCCI are structured to continue to meet these expectations. The Executive Director oversees a team of highly skilled and efficient clinical research staff charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program. Provides expertise, guidance, and oversight to the operational units within the CTO (clinical, regulatory, finance, quality, training, information systems, etc.) including but not limited to activities necessary to support:
Leadership towards implementing requirements as outlined in the National Cancer Institute's, Cancer Center Support Grant guidelines relative to all clinical trial requirements (i.e. Clinical Protocol and Data Management, Protocol Review and Monitoring System, Data and Safety Monitoring, Accrual of Women and Minority to clinical trials and associated Data Tables);
Oversee the structure and processes of the PRMS, DSMB, and other committees established to monitor the performance of the SOCCI CTO or the quality of clinical research in the SOCCI;
Oversee the development, implementation, and updating of SOPs to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the fiscal integrity of clinical trial activities;
Administrative management of the electronic systems utilized to monitor CTO performance and efficiency and participation in the development or the selection of institutional systems that would impact the CTO operations and conduct of clinical trials in the SOCCI;
Provide oversight for generation of monthly reports including but not limited to CTO performance, accrual, monitoring, time to activation, audit visits, and financial performance. Ensure accuracy of clinical trial information in all CTMS, clinical trial databases, and tracking systems. Ensure quality, timely, and accurate data and report submission;
Facilitate the expansion of SOCCI clinical trial programs across Cedars-Sinai Cancer Network and Affiliate sites in conjunction with institutional leadership;
Integration of Cedars-Sinai and the SOCCI central research administration initiatives and serve as a pilot for expanding clinical trial support services enterprise-wide as appropriate;
Represent the SOCCI CTO on Health System committees and task forces. Serve as liaison to advance clinical trial interests including participation in community outreach;
Oversee financial resources, development, and management of the CTO annual operations budget and of clinical trials budgets;
Other duties as assigned.
Demonstrates behavior that supports the Cedar-Sinai Health System mission. Attends required orientation and training seminars. Meets production standards within established time requirements. Work product and performance meets quality standards. Demonstrates respect and positive interpersonal skills with patients (if applicable), clients, the public managers, and co-workers - a team player. Maintains confidentiality of patient care and business matters. Observes Medical Center policies and procedures. Protects the safety of others and of the physical plant and equipment, following institution policies, fire and safety, and infection control regulations.
Supervises: Health System Managers, Research Program Managers, Clinical Research Specialists, and others as may be assigned.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.