The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer (SOCCI), 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.
Join our team and use your expertise with an organization known nationally for excellence in cancer research.
The Clinical Research Data Coordinator II for the CCTO Lab works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. The Clinical Research Data Coordinator II will work primarily in the Research Lab to assist with sample preparation, shipping, and maintenance of study supplies and kits for clinical trial protocols. In Addition, this role may involve evaluation and abstraction of research data and data entry while ensuring compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Responsible for sample preparation, shipping and maintenance of study supplies and kits.
Assists with all lab duties to ensure proper conduct of clinical trial specimen processing.
Assists with preparation of laboratory manuals for Investigator Initiated studies.
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Maintains all internal specimen processing tracking forms and spreadsheets including integration with OnCore.
Ensures compliance with protocol and overall clinical research objectives including reporting all deviations per protocol requirements.
Completes Case Report Forms (CRFs).
Assists with clinical trial budgets as related to laboratory specimen processing and laboratory supply cost.
Assists with patient research billing as it relates to specimens processed or analyzed within the CCTO laboratory.
Maintains schedule of patient visits and provides laboratory kits for phlebotomy laboratory.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
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 t...eaching 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.