Clinical Research Coordinator I - Cancer Clinical Trials Office
Cedars-Sinai Medical Center
Location: Los Angeles, California
Internal Number: 20002436A
At Cedars-Sinai, we're motivated by a collective spirit of innovation and the challenge to continuously improve. Above all, we share a real passion for helping others. Day after day, from department to department, our people give their all to create a community unlike any other. This is just one of the many reasons U.S. News & World Report has named us one of America's Best Hospitals--and now we invite you to join us and make a difference every single day in service of this outstanding work - excellence and innovation in patient care, research, and community service. From working with a team of dedicated professionals to using state-of-the-art facilities, you'll have great resources to do something incredible--for yourself, and for others!
Essential Job Duties:
As Clinical Research Coordinator (CRC) I, you will work 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. You will be 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 Clinical Research Coordinator I, you will also be responsible for the following:
Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information
Document thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintain accurate source documents related to all research procedures.
Schedule patients for research visits and procedures.
Schedule and participate in monitoring and auditing activities.
Notify direct supervisor about concerns regarding data quality and study conduct.
Work with regulatory coordinators or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May assist with other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintain research practices using Good Clinical Practice (GCP) guidelines.
Maintain 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.