Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology - Per Diem

Cedars-Sinai•Beverly Hills, CA

About The Position

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. We invite you to consider this phenomenal opportunity! Dr. Ju Dong Yang, in Department of Medicine, Karsh Division of Gastroenterology and Hepatology is looking for a new Clinical Research Associate I to join the team! Dr. Yang is an Associate Professor in the department of Medicine, Karsh Division of Gastroenterology and Hepatology and Cancer Institute, Medical Director of the Liver Cancer Program. His research program focuses on clinical and translational liver cancer research. He is currently conducting liver cancer biomarker studies which have reported that circulating tumor cells (CTCs) are detectable in liver cancer patients and are independent predictors of patient survival. The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Responsibilities

Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs).
Provides supervised patient contact or independent patient contact for long term follow-up patients only.
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient research billing.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinical research objectives. 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.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May serve as one point of contact for external sponsors for select trials.
May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.