Clinical Research Office
The Clinical Research Office (CRO) has overall responsibility for the performance of cancer trials and other cancer research studies at the Samuel Oschin Comprehensive Cancer Institute and provides support and services to faculty and staff conducting oncology research. This includes coordination of staff support, provision of centralized systems, regulatory expertise, and quality assurance.
Centralized systems will be easily accessible through our website. These systems include a protocol library which will contain all active cancer-related protocols, a Protocol Review and Monitoring Committee online forum which will track documents and reviews, and a research manual with up-to-date documentation of standardized research procedures.
The goals of the CRO are to:
- Facilitate, direct and coordinate cancer clinical research within the SOCCI
- Serve as a single point of contact for research-related resources including protocol design, forms development, data coordination, and regulatory compliance
- Support clinical research by providing a centralized, specifically trained, and supervised core staff of clinical research nurses, research coordinators, regulatory specialists, and data managers
- Develop and maintain an active protocol library accessible by all SOCCI cancer researchers and staff
- Assist in protocol review and assess the feasibility of clinical research studies within the SOCCI
- Serve as a central resource for clinical research education, training and staff development for physicians, scientists and research staff
- Develop and promulgate standards, 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
- Provide assistance and advice to investigators regarding FDA documentation including submission of IND applications; provide support for IRB submissions and communications
- Facilitate clinical research by interfacing with research pharmacy, laboratory, pathology, medical records, budgeting, grants and contracts offices, and with external research sponsors
- Collaborate with research informatics faculty and staff to provide standard databases for research; data management tools; and monitoring of study accrual
The CRO will maintain regulatory binders for Industry, investigator-initiated, and Cooperative Group trials in accordance with federal regulations. Common regulatory documents include the IRB approval letter, FDA Form 1572, CVs, medical licensure, and Financial Disclosure Forms. We have centralized resources and templates for providing commonly requested regulatory documents to Industry sponsors, drug manufacturers, and federal oversight agencies.
For more information, contact us at:
Cedars-Sinai Medical Center
8700 Beverly Blvd.
Los Angeles, CA 90048