Job Description
Join us as we translate todays discoveries, into tomorrows medicine! Regenerative medicine is a new and developing field that strives to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. Were also exploring how to prevent diseases, and were extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai
Are you ready to be a part of breakthrough research? The Clinical Research Associate I will work 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.
Responsibilities:
• 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 • 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
Department-Specific Duties and Responsibilities
• Performs data searches and other related administrative tasks • Assists with research protocol writing and development • Transportation of research medications • Performs study related assessments and questionnaires • Assists with prescreening of potential research participants for various clinical trials • Maintains organized paper and electronic research files • Performs all data collection and data entry tasks for department clinical trials • Assists with preparing manuscripts, letters, and other research documents as needed • Responds to sponsor' inquiries regarding protocol start-up activities and recruitment • Performs literature reviews • Attends research meetings and monthly conference calls with sponsors for study updates • Performs cell culture, immunohistochemistry including processing of samples • Performs animal injections, dissections and surgery • Assists with scheduling of visits and assessments
Qualifications
Education:
High School Diploma or GED is required.
Experience and Skills:
Clinical Research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to follow regulations. Must possess digital literacy, including Word and Excel, and the ability to use standard office equipment is required.
Cedars Sinai is one of the largest nonprofit academic medical centers in the United States, and it is the largest private academic medical center in the Western United States. The Cedars Sinai main campus, which encompasses nearly 24 acres, is located at the point where the cities of Los Angeles, Beverly Hills, and West Hollywood meet. Cedars Sinai has been recognized annually by U.S. News & World Report’s top 10 best hospitals in the U.S. The institution most recently placed No. 7 among a select group of 20 Honor Roll hospitals and ranked nationally in a dozen specialties. In addition, Cedars Sinai ranked No. 3 in California and No. 2 in the Los Angeles metro area.
Within Cedars Sinai, the Institute for Research on Health Aging conducts multi-disciplinary research that prioritizes the prevention of cardiovascular disease, neurocognitive disease, and cancer. Our focus is on translating new research discoveries into pragmatic interventions aimed at promoting healthy aging across diverse populations. Our approach involves human physiology, cohort, and clinical trial studies and our team includes established experts in population, clinical, translational, basic, and data science.