Cancer Clinical Trials Office
Staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), the Cancer Clinical Trials Office (CCTO) is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer, including its medical network and health system, which at any given time has approximately 140 cancer clinical trials. CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout. We are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.
Mission
To deliver innovative clinical trials and superior medical expertise to improve patients' lives, contribute to scientific knowledge and work toward more effective cancer treatment.
Core Values
- Integrity
- Collaborator
- Advocacy
- Respect
- Excellence
Operational Units & Services
The Cancer Clinical Trials Office at Cedars-Sinai Cancer has several operational units that perform specific functions to support investigators and their clinical trials. This includes quality assurance, regulatory affairs, financial operations, clinical coordination, education and training of clinical staff, study coordination/clinical research support and data coordination.
- Provides investigator-initiated protocol development services, Institutional Review Board (IRB) submission and efficient, compliant and timely activation of investigator-initiated clinical trials
- Provides assistance with writing and filing U.S. Food and Drug Administration Investigational New Drug (IND) and Investigational Device Exemption (IDE) application submissions
- Negotiates for novel agents with industry sponsorship
- Assistance with clinicaltrials.gov reporting
- Assists investigators to assess the feasibility of new clinical research opportunities
- Works collaboratively with principal investigators (PIs), study team and core units to operationalize protocols and manage the portfolio of studies in a disease- or work area-specific group
- Maintains an in-depth understanding of the study protocol to ensure the safe enrollment of patients in cancer clinical trials and compliance with study protocol–defined procedures
- Provides education to staff, families and participants on clinical trials
- Ensures patient compliance with protocol requirements
- Responsible for successful protocol operations within the services/department they manage
- Works with clinical research leadership to create and harmonize workflows
- Provides specialized care coordination and symptom management to our research patients, serving as a central contact for both the patient and the patient's family during their participation in a clinical trial
- Provides real-time submission of study case reports forms and ongoing customer service to our study sponsors and collaborators
- Supports monitoring visits and ensures that all data queries are resolved in a timely manner
- Facilitates reporting of clinical cancer research per NCI requirements and data collection in RedCap
- Conducts central monitoring of both single site and multisite Cedars-Sinai Cancer investigator-initiated trials
- Ensures high quality and timely submission of data to the Data and Safety Monitoring Committee
- Conducts internal audits and routine monitoring of single site and multisite investigator-initiated trials based on the classified risk of the study
- Provides centralized training and education to staff and physicians who conduct cancer clinical research
- Works with the education specialist to deliver tailored outreach, training and education based on internal monitoring and auditing findings
- Develop SOPS and policies and procedures for the proper conduct of clinical research in accordance with ethical standards and in compliance with federal, state and local regulatory requirements
- Provides efficient, compliant and timely activation of national cooperative group, externally peer-reviewed and industry clinical trials
- Supports investigators to maintain regulatory compliance throughout the duration of a clinical trial
- Facilitates new IRB submissions, amendments, annual reviews and processes safety reports
- Core services—budget development, billing compliance, revenue management, fiscal management and reporting
- Evaluation of qualifying clinical trial status and preparation of Medicare coverage analyses
- Budgeting and invoicing for industry sponsored and/or funded clinical trials
- Budget and expense monitoring and reconciliation of industry sponsored and/or funded clinical trials
- Budget and expense monitoring and reconciliation of Cedars-Sinai sponsored clinical research
- Coordinate fund establishment and close out for clinical research studies
- Financial reporting associated with industry sponsored clinical trial activity
- Regular educational meetings for research staff
- Orientation for new hires
- Supports clinical research studies through the Oncore Clinical Trials Management System
- Post-trial listing to Cedars-Sinai website, clinicaltrial.gov and NCI CTRP
- Develops study calendars and sets up OnCore access specific to usage
- In conjunction with Enterprise Information Services (EIS), design optimal data flows to minimize data entry and increase operational efficiencies
- Establishing queries and reports for PIs and users to review and analyze their data
Have Questions or Need Help?
If you have any questions or wish to learn about the Cancer Clinical Trial Office, please call us.
8700 Beverly Blvd.
Los Angeles, CA 90048