The Cedars-Sinai Center for Outcomes Research and Education (CS-CORE) is a group of academicians that supports high quality research efforts using a health services research model. Members of the center have published extensively in the fields of healthcare quality measurements, patient-reported outcome (PRO) development, healthcare decision making, health economics and digital health sciences.
CS-CORE maintains a balance between clinical physicians with training in health services research, and rigorously trained methodologists with expertise across a wide range of techniques. This allows the center to apply advanced analytic techniques to practical, clinically oriented research projects that ultimately revolve around patients and their perspectives.
Members of CS-CORE routinely interact with social scientists, epidemiologists, health economists, psychometricians, biostatisticians, computer scientists, engineers and physicians focused in multiple medical specialties. CS-CORE scientists work closely across Cedars-Sinai and partner with a vibrant external community of university, government and healthcare institutions. This model positions CS-CORE to carry out high-level research in an efficient and effective manner across a broad spectrum of topics.
The Clinical Research Coordinator I works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities:
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Scheduling of patients for research visits and procedures.
Maintains accurate source documents related to all research procedures.
Schedules and participates in monitoring and auditing activities.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
Bachelor of Science or Bachelor of Arts Degree, required.
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.