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Clinical Research Associate I
2 months ago
The Clinical Research Associate I collaborates closely with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to facilitate and/or execute the clinical study.
This role involves evaluating and abstracting research data while ensuring adherence to the study protocol and research goals. Responsibilities include completing case report forms, entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). Limited patient interaction may be required for study purposes, along with support for study budgeting and patient research billing.
Key responsibilities include:
- Evaluating and abstracting clinical research data from source documents.
- Ensuring compliance with the study protocol and overall clinical research objectives.
- Entering clinical research data into Electronic Data Capture (EDC) systems provided by sponsors.
- Assisting with regulatory submissions to the IRB, including the submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal regulations.
- Supporting clinical trial budget management.
- Assisting with patient research billing processes.
- Scheduling patients for research visits and procedures.
- Managing sample preparation, shipping, and the maintenance of study supplies and kits.
- Ensuring compliance with all federal and local regulations, including those set by the Food and Drug Administration (FDA) and local IRB.
- Maintaining research practices in line with Good Clinical Practice (GCP) guidelines.
- Participating in mandatory training and educational programs.
A Bachelor's Degree in Science, Sociology, or a related field is preferred, along with one (1) year of experience in clinical research.
Cedars-Sinai is recognized for its commitment to delivering high-quality healthcare, which encompasses primary care, specialized medicine, and research initiatives. Established in 1902, Cedars-Sinai has continuously adapted to meet the diverse needs of the community, setting benchmarks in quality patient care, research, education, and community service.
Today, Cedars-Sinai is acknowledged for its national leadership in advancing healthcare for the benefit of patients, impacting the future of healthcare through innovative treatment approaches and the education of future health professionals. The institution also demonstrates a strong commitment to community health through programs aimed at improving the well-being of its most vulnerable residents.
Cedars-Sinai stands as one of the largest nonprofit academic medical centers in the U.S., featuring 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff.
This position offers an opportunity to work in a dynamic environment that provides the highest level of care to individuals in need.