Grow your career at Cedars-Sinai!

Cedars-Sinai offers a culture of happiness, passion, and dedication. This is one of the many reasons why we rank as one of the top hospitals in California and in the nation by U.S. News & World Report.

The Karsh Division of Gastroenterology and Hepatology offers trusted care from doctors and researchers who have pioneered many of the diagnostic techniques and surgical treatments widely used to treat digestive and liver diseases.

Dr. Hirsh Trivedi, MD is looking for a Clinical Research Coordinator I to join his research team. Dr. Trivedi's research program focuses on the diagnosis and management of metabolic-dysfunction associated fatty liver disease (MAFLD) and metabolic associated steatohepatosis (MASH). To learn more about Dr. Trivedi's research program please visit this website.

Do you have a passion for helping human kind?

The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants 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. This position presents this information at research staff meetings and 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:

• Schedules research visits and procedures for enrolled participants.
• In collaboration with the physician and other medical personnel, documents completely 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 compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Schedules and participates in monitoring and auditing activities.
• 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.
• 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.

Education:

• High School Diploma/GED is required.
• Bachelor's or Master's degree is preferred.

Experience:

• One year of clinical research or coordinating clinical research trials experience is required.

#LI-On-site