As a Clinical Research Associate I, you will work with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate/implement studies. You will e valuate and abstract clinical research data from source documents and e nsure compliance with protocol and overall clinical research objectives.
Essential day to day job duties and responsibilities include:
Complete Case Report Forms (CRFs).
Enter clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provide supervised patient contact or patient contact for long term follow-up patients only.
Assist with regulatory submissions to the institutional Review Board (IRB) and works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serous Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assist with clinical trial budgets.
Assist with patient research billing.
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.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.