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As the Clinical Research Manager - Clinical Operations for the CCTO of the Samuel Oschin Comprehensive Cancer Institute (SOCCI) you will be responsible for the planning, organizing, managing, and controlling the daily operations of assigned areas of the CCTO and SOCCI and ensures development is consistent with NCI Comprehensive Cancer Center designation. Assures all program development related to clinical trials within the CCTO follows the guidelines mandated by Federal and local requirement s including FDA research regulations and the International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs) and the Cedars Sinai Institutional Review Board.
As the Clinical Research Manager- Clinical Operations you will also be responsible for:
Ensuring all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol.
Provide guidance to staff in establishing priorities to ensure that workflow is controlled and meets the needs of the department. Communicates and ensures compliance with institutional/departmental priorities, initiatives, safety standards, and external legal regulations.
Build and manage a team of highly skilled and efficient clinical research staff including program managers, clinical research coordinators, clinical research associates, and research nurses in an effort to assure compliance with regulatory agencies and increase procedures and efficiencies with the ultimate goal of increasing enrollment on clinical trials at SOCCI.
Serve as the senior on-site manager for the clinical operations established by the CCTO for which the SOCCI strategic plan.
Direct and facilitate the process of new protocol development, review and implementation within the Department. Anticipate the effects of changing regulatory requirements. Direct the development of policies, procedures, and quality standards.
Directs the functions and activities of staff. Responsible for interviewing, hiring and training of new clerical and management (Research) employees.
Responsible for implementing a program to mentor new clinical research staff as well as providing ongoing education through focused in-services and recurrent meetings for cancer institute staff: research nurses, study coordinators, and data managers.
Performs regular audits on departmental research projects, databases and research protocols to ensure data quality is complete and accurate.
Collaborates with the Quality Management Core to ensure comprehensive quality assurance (QA) and quality control (QC) program throughout the cancer institute.
Serves as the SOCCI resource for sponsor, cooperative group, and federal audits and is available to investigators and the research staff for routine and for-cause audit preparation and assistance.
Develops and maintains Working Instructions, document templates, and guidelines for the conduct of cancer clinical trials and other research at the SOCCI.
Attends local and national meetings assigned by the Institute and CCTO Associate Director and assures positive representation at these meetings.
Completes assigned projects related to clinical research infrastructure development that will include but not be limited to cancer research radiology core services, research laboratory efficiencies, and research pharmacy infrastructure and will participate in the prioritization and scientific review of cancer protocols at the SOCCI Protocol Review and Monitoring Committee
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.