Clinical Research Associate I - Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai in Los Angeles, CA, United States

Job description

• 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!
• 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. Walid Ayoub, MD is looking for a Clinical Research Coordinator I to join his research team. Dr. Ayoub is the Director of the Autoimmune and Cholestatic Liver Disease Program at Cedars-Sinai Medical Center.
• As a Clinical Research Associate I, you 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. This position will be responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I member may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Responsibilities

• Ensures compliance with protocol and overall clinical research objectives.
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets and 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 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.
• Participates in required training and education programs.

Requirements

• High School Diploma/GED is required.
• Bachelor's degree in Science, Sociology, or related degree is preferred.
• ACRP/SoCRA certification is preferred.
• Clinical research experience is highly preferred.
• Understanding of general research objectives.

Skills

Required

• Regulatory submissions to IRB
• Patient scheduling
• Sample preparation and shipping
• Good Clinical Practice (GCP) guidelines
• Patient confidentiality (HIPAA)

Preferred

• Clinical research experience
• ACRP/SoCRA certification