Clinical Research Coordinator II - Pulmonary Research Program/Lung Institute

About the role

Join Cedars-Sinai and become part of a team at the forefront of medical advancements, working alongside physician-scientists and researchers making life-saving breakthroughs. As a Clinical Research Coordinator II, you will independently provide study coordination, including screening potential patients for protocol eligibility, presenting non-medical trial concepts, and participating in the informed consent process.

Responsibilities

• Schedules patients for research visits and procedures.
• In collaboration with physicians and medical personnel, documents changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug on Case Report Forms (CRFs).
• 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/IRB duties, budgeting duties, and assist 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.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May identify quality and performance improvement opportunities and collaborate on action plans.
• May identify new research opportunities and present them to investigators.
• Participates in required training and education programs.
• Compiles and reports on each study, including protocol activity, accrual data, workload, and other research information.
• Presents information at research staff meetings and may plan strategies to increase patient enrollment, improve efficiency, or train personnel.

Requirements

• High School Diploma/GED, required.
• Bachelor’s degree, preferred.
• 2 years of clinical research-related experience, required.

Qualifications

• ACRP/SOCRA (or equivalent) certification, preferred.