Cedars-Sinai is uniquely positioned at the forefront of translational research to improve women's health across a wide array of disciplines. The purpose of the Prenatal Repository is to gather tissue samples and data to investigate causes of pregnancy complications, such as delivering a premature or small baby and developing diabetes or hypertension during pregnancy. By collecting this information, researchers can explore the possibility of developing new methods of prenatal diagnosis that may be completed earlier or less invasively to identify women at risk. Additionally, samples and clinical information collected as part of this repository may be used to support future research that aims to further scientific knowledge about prenatal development.
As Clinical Research Coordinator (CRC) I, you will work independently and in part with Prenatal Biorepository by 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. This role is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
As a CRC I, additional duties and responsibilities include:
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
Maintains accurate source documents related to all research procedures
Schedules and participates in monitoring and auditing activities
Schedules patients for research visits and procedures
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
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 perform 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
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.