Clinical Research Associate I- Smidt Heart Institute (Makkar Lab)

Job DescriptionKey Job ResponsibilitiesThe Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. 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 and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.Primary Duties and 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 programsQualificationsEducational Requirements:- Highschool Diploma Required - Bachelor's Degree PreferredLicenses: N/AExperience:1 year clinical research experience preferredPhysical 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 operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.About the TeamCedars-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. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.