When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only.
Primary Duties & Responsibilities:
? Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
? Evaluates and abstracts clinical research data from source documents.
? Ensures compliance with protocol and overall clinical research objectives.
? Completes Case Report Forms (CRFs).
? 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.
? Assists with patient research billing.
? Schedules patients for research visits and research procedures.
? Responsible for sample preparation and shipping and maintenance of study supplies and kits.
? Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
? 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
Educational Requirements:
High School Diploma/GED
Bachelors degree in science or related degree preferred
Experience:
1-year clinical research related experience preferred
Physical Demands:
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 exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Understanding of? general clinical research objectives. Clinical research experience, preferred
About Cedars-Sinai Medical Center
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 competi ... tive 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.
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