Job Summary:
• Attend monthly research meeting
• Email weekly updates regarding the active research projects
• Act as patient liaison for clinical studies and be present in OR/clinic for necessary parts of the study.
o Identify patients eligible for studies
o Assist in consenting process
o Ensure appointments are scheduled and fulfilled in accordance with study protocol
• Ensure delivery of research materials to OR and availability for surgery
• Keep data from clinical studies up-to-date and available to research team
• Facilitate the IRB submission, revision process, and follow up on any questions from IRB staff in a timely
manner.
• Promptly report issues with research team so that they can be addressed in a timely manner.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Assists 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.
• Assists with patient research billing.
• 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.
Tags: Los Angeles, CA