Clinical Research Associate I - Regenerative Medicine Institute

Job Description Join us as we translate today's discoveries, into tomorrow's 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. We're also exploring how to prevent diseases, and we're 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. 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. Additionally, this position will include animal work (injections, dissections, and surgery), sample processing, and cell culture. Primary Job Duties and 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. #J-18808-Ljbffr