Clinical Research Coordinator I - Karsh Division of Gastroenterology and Hepatology

Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.This position will provide support to the Fatty Liver Program in the Comprehensive Transplant Center under the direction of Dr. Walid Ayoub. The Cedars-Sinai Fatty Liver Program provides advanced diagnosis, treatment and ongoing research to protect your liver and your health.As a Clinical Research Coordinator I, you will work independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. This position is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is also responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The CRC I member presents study 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 patients for research visits and procedures.

In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following - changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.

Maintains accurate source documents related to all research procedures.

Schedules and participates in monitoring and auditing activities.

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.

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, required.

Bachelor's degree in a Science, Sociology, or related field is preferred.

Licenses/Certifications:

ACRP/SoCRA certification is preferred.

Experience:

One (1) year of clinical research experience, required.

Working Title: Clinical Research Coordinator I - Karsh Division of Gastroenterology and HepatologyDepartment: Home Dept - Medicine ResearchBusiness Entity: Cedars-Sinai Medical CenterJob Category: Academic/ResearchJob Specialty: Research Studies/Clinical TrialsPosition Type: Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay: $23.39 - $39.76Cedars-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.