Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.
The Division of Rheumatology at Cedars-Sinai has established a comprehensive clinical and translational research program. This Division is involved in a streamlined infrastructure to support prospective cohorts of patients affected by rheumatic diseases (i.e. disease-based centers of excellence revolving around conditions such as scleroderma, systemic lupus erythematosus, rheumatoid arthritis) and participation in ground breaking clinical trials.
As a Clinical Research Coordinator III (CRC III), you will work closely with the Division Program Manager, Clinical Research Coordinator Team and Scleroderma Center Investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting. You will provide study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Responsible for oversight of studies assigned within the group and provides support with managing the clinical research portfolio and daily operations of studies for the investigator or disease group.
Provides study coordination for assigned projects, including patient screening and consenting, regulatory reporting, completion required data collection, maintenance of source documents, facilitation of all study logistics to ensure successful protocol implantation and patient safety.
Scheduling of research participants for research visits and procedures.
Participates in project feasibility reviews and study initiation visits and provides strategic guidance on study set-up and implementation.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following - changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
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.
Advises direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
High School Diploma/GED, required
Bachelors of Science, Sociology, or related field, preferred
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.