Reporting to the Executive Director of the Samuel Oschin Comprehensive Cancer Institute (SOCCI) Clinical Research Office (CRO), the Associate Director of Clinical Research Administration is responsible for directing and managing services supporting cancer clinical research across all participating Cedars-Sinai Cancer locations. This CRO leader will direct these essential, quality-driven units in providing support to SOCCI investigators and their growing clinical research programs while providing mentorship and training to both SOCCI CRO staff and investigators on matters of compliant clinical research conduct (i.e. Good Clinical Practices). Working closely with CRO, SOCCI and Cedars-Sinai leadership, the incumbent will design, implement, and evolve operational standards while monitoring quality and anticipating needs to support continued growth of SOCCI's clinical research program. As part of the CRO's senior leadership team, this position will contribute to SOCCI's future planning initiatives to ensure ongoing engagement and alignment necessary to support SOCCI's pursuit of National Cancer Institute designation. As is expected of any leadership position, this position requires close collaboration both internally within SOCCI as well as externally across Cedars-Sinai (C-S), the C-S Medical Delivery Network, and C-S Health System Affiliate sites participating in SOCCI-related cancer clinical research.
DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
Protocol Development Core Guidance.
Provide guidance and oversight of the Protocol Development Core (PDC) by monitoring volume, capacity, and quality while assessing service offerings and forecasting needs to ensure the provision of quality support for SOCCI initiated trials. Interface with external sponsors and/or agencies in conjunction with the PDC Project Manager and ensure PDC core leadership and staff exhibit leadership, monitors time-lines, communicate and provide efficient, effective services.
Training and Education.
Provide guidance and oversight of the Training and Education Program Manager to help develop a comprehensive, enterprise-wide cancer clinical research training program.
Quality Monitoring Core.
Provide leadership and oversight to the Quality Monitoring Core (QMC) in accordance with the services provided to SOCCI investigators and participating sites. Services to include:
Conduct of DSMC Audits
Perform Eligibility Reviews for IIT, NCTN clinical trials
Prepare for internal/external audits and provide auditor management
Contribute to training and education efforts for CRO staff and faculty
NCI Committee Management.
Lead and enhance the conduct of National Cancer Institute (NCI) committees in accordance with approved committee charters. In conjunction with committee staff and Chairs, provide faculty and staff education regarding the charge and purpose of the committees and identify opportunities to improve committee function. Committee oversight to include:
Protocol Review and Monitoring Committee
Data & Safety Monitoring Committee
Clinical Research and Leadership Committee
Clinical Research Informatics.
In collaboration with EIS Research Informatics design, implement, monitoring and evolve data tracking and reporting tools to provide support and quality data on which leaders, faculty and staff can make data-driven decisions.
National Clinical Trials Network.
Establish monitoring and reporting processes in addition to providing oversight and strategic guidance relative to SOCCI's performance in the NCI's National Clinical Trials Network (NCTN). In conjunction with SOCCI leadership, identify NCTN opportunities to strengthen SOCCI's performance and position SOCCI to be competitive in future NCTN grant funding mechanisms. With NCTN staff support ensure ongoing compliance with NCTN/CTEP registration in addition to tracking SOCCI contributions such as:
Manage SOCCI NCTN group membership(s)
Overseeing NCTN investigator/CTEP registrations
Track/catalog SOCCI-wide NTCN contributions,
Support progress towards potential NCORP grant application
Strategic Planning. Actively participates in the strategic planning process of SOCCI's Clinical Research Office. Represents the Clinical Research Office on University/Hospital committees and task forces as assigned. Serves as a liaison to promote clinical research at local, state, and national levels.
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 rese...arch 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.