Clinical Research Associate I
4 weeks ago
Cedars-Sinai is seeking a highly motivated Clinical Research Associate I to join our team in the Karsh Division of Gastroenterology and Hepatology. This role will work closely with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and implement clinical trials.
The Clinical Research Associate I will be responsible for evaluating and abstracting research data, ensuring compliance with protocol and research objectives. This includes completing case report forms, entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The incumbent will also provide limited patient contact as needed for study purposes and assist with study budget and patient research billing.
Key Responsibilities:
- Enter clinical research data into Electronic Data Systems (EDCs) provided by sponsors.
- Provide supervised patient contact or patient contact for long-term follow-up patients only.
- Work closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters following local and federal guidelines.
- Schedule patients for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Ensure compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local IRB.
- Maintain research practices using Good Clinical Practice (GCP) guidelines.
- Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
- Participate in required training and education programs, including CSMC phlebotomy-specific clinical oversight.
Requirements:
- High School Diploma/G.E.D., required.
- Bachelor's degree in Science, Sociology, or related degree, preferred.
- ACRP/SoCRA certification is preferred.
- Clinical Research experience is highly preferred.
About Us:
Cedars-Sinai is a leader in providing high-quality healthcare, encompassing primary care, specialized medicine, and research. We are committed to transforming healthcare for the benefit of patients and the community.
About the Team:
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff. We offer a fast-paced environment that provides the highest level of care to people in the Los Angeles area who need our care the most.
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