Clinical Research Coordinator III
1 month ago
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.
As a Clinical Research Coordinator III, you will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. This position is responsible for the oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. The incumbent plans and coordinates strategies for growing research participant enrollment, improving efficiency, training of personnel, and identifying new research opportunities. The CRC III member 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:
Scheduling of 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, response to study drug. Maintains 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 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. 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, 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. Works with Training and Education Coordinator to ensure all staff is properly trained and certified. Participate in centralized activities such as auditing, Standard Operating Procedure development, etc. Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. Identifies new research opportunities and presents to investigators. Supervises other research staff.Education:
High School Diploma/GED, required. Bachelor's degree, preferred.Licenses/Certifications:
ACRP/SOCRA (or equivalent) certification, preferred.
Experience:
4 years of clinical research experience, required.
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