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The Clinical Research Coordinator II works independently providing study coordination support for prospective epidemiologic studies and clinical trials. Responsibilities may include screening of participants for eligibility, presenting an overview of study motivation and procedures, administering questionnaires, scheduling and follow-up of research study participants, transporting biospecimens from procedure rooms to the processing laboratory.
Essential Job Duties and Responsibilities:
Independent study coordination including screening of prospective patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents 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.
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 research staff meetings.
Notifies 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 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.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local IRB.)
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators.
Participates in required training and education programs.
Conducts literature reviews and assists in the design of investigator-initiated studies including protocol design and development.
Works with PI to design and develop study related documents including questionnaires, CRFs, manual of operations, and tracking forms for assigned studies.
Establishes data collection process for studies and standardize data collection, including data flow, data management, data entry, error identification and correction.
Work closely with Principal Investigator (PI) to organize research study implementation, enrollment, and tracking of study conduct and progress for studies.
May be trained on study related machine/equipment and procedures by either study sponsor, PI, or PI designee, if necessary for research study.
May conduct non-invasive clinical assessments (e.g., vital signs, FibroScan) for research purposes, if applicable, according to Cedars-Sinai policies.
Trains and communicates with coordinators at other institutions for protocol implementation.
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.