Cedars-Sinai Clinical Research Associate I - Hepatology in Los Angeles, California
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
The research program of Ju Dong Yang, MD, has been focused on clinical and translational research of liver cancer. Dr. Yang conducted several population-based cohort studies to describe recent trends in liver cancer epidemiology in the United States. He published several outcome research papers in liver cancer. Dr. Yang has also conducted several modeling studies and proposed a survival prediction model in liver cancer patients. He has also conducted a multistate Markov model study and investigated the impact of liver cancer surveillance on overall survival in patients with cirrhosis. In addition, Dr. Yang has been interested in liver cancer health disparities research from a global perspective. His research highlighted that Africans have a very early onset of HCC with extremely poor survival. Finally, Dr. Yang has been interested in liver cancer biomarker research. He and his colleagues have reported that circulating tumor cells (CTC) are detectable in liver cancer patients and are independent predictors of patient survival. Our more recent study indicated that circulating cell-free tumor DNA mutation and methylation are promising diagnostic or prognostic biomarkers in liver cancer.
The Clinical Research Associate I (CRA I) in Hepatology will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs), entering clinical research data, and assist with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised contact with research participants or contact for long term follow-up research participants only.
Works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the FDA and local IRB.
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.
- Bachelor of Art or Sciences degree, or equivalent combination of education and experience.
Experience and Skillset:
- Understanding of general clinical research objectives. Clinical research experience, preferred.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.