As a Clinical Research Coordinator II, you will join the research team at the Center for Cardiac Arrest Prevention directed by Dr. Sumeet Chugh and located within the Cedars-Sinai Smidt Heart Institute. The overall goal of this Center is to predict and prevent sudden cardiac arrest, a mostly lethal condition. You will work independently providing study coordination including screening of potential patients for protocol eligibility participating in the informed consent process and working as a project coordinator for one or more assignments.
Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Scheduling of patients for research visits and procedures.
- Maintain accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Schedules and participates in monitoring and auditing activities.
- Responsible for setting up a project management plan for one or more projects in consultation with the Center director and senior research staff and be responsible for ongoing project management.
- 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 involve other regulatory / Institutional Review Board duties, and budgeting duties.
- Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
- Maintain research practices using Good Clinical Practice (GCP) guidelines.
- Maintain 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 plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- May identify new research opportunities and present to investigators.
- Participate in required training and education programs.
- BA/BS degree
- Four (4) years minimum of directly related experience
- Working Title: Clinical Research Coordinator II - Smidt Heart Institute - Dr. Sumeet Chugh's Laboratory
- Department: Heart Institute Operations
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic / Research
- Job Specialty: Research Studies / Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day