- Ensures compliance with clinical research objectives.
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Provides supervised patient contact or patient contact for long-term follow-up patients only.
- 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 and patient research billing.
- Scheduled patients for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Assists with acquiring patient consent, sample collection, data entry, assistance with manuscript, and abstract writing and submissions.
- High School Diploma or GED, required.
- Bachelor's degree in Science, Sociology, or related degree, preferred.
- One year of clinical research experience, preferred.
- Understanding of general clinical research objectives.
Clinical Research Associate I - Los Angeles, United States - Cedars-Sinai
Description
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.
This position will provide support to the Department of Neurology under the direction of Dr. Alexis Simpkins.
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. This position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study. This role will follow all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
*This position is hybrid*
Primary Job Duties and Responsibilities:
Department-Specific Information:
Education:
Experience and Skills:
Physical Demand:
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.