Clinical Research Coordinator II
1 month ago
Job Description Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements
The Clinical Research Coordinator II works independently providing study coordination including screening of patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. The team member in this position will work closely with Scleroderma Program and Rheumatology faculty investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting.
Researchers and doctors in our Division of Gastroenterology and Hepatology continue to be at the forefront of groundbreaking tests and treatments for all types of digestive and liver diseases, while driving groundbreaking research to improve patient care.
Schedules 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 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 perform other regulatory / Institutional Review Board 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 Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
May coordinate training and education of other personnel.
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.
Bachelor's degree in a Science, Sociology, or related field is preferred.
Two years of clinical research experience, required.
#Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Working Title : Clinical Research Coordinator II – Gastroenterology and Hepatology Division/Department of Medicine
Department : Research - General Medicine
Business Entity : Cedars-Sinai Medical Center
Academic / Research
Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
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