Clinical Research Associate I - Melmed Lab | Cedars-Sinai Medical Center - Military Veterans

at HERC - Southern California

Los Angeles, California

Principal Investigator, Dr, Gil Melmed, is seeking a Clinical Research Associate to join the team! Cedars-Sinai is home to some of the most advanced biomedical research and training programs in the world, which attracts renowned physician-scientists seeking an unparalleled environment for fostering invention and teamwork. Are you ready to be a part of breakthrough research? Dr. Gil Melmed's clinical research team is searching for a highly motivated Clinical Research Coordinator II/CPT to be a part of an exciting opportunity within the Inflammatory Bowel and Immunobiology Research Institute (IBIRI) at Cedars-Sinai. IBIRI is a multidisciplinary basic, translational and clinical research program devoted to Inflammatory Bowel Diseases. The research of Gil Melmed, MD, focuses on clinical outcomes research in inflammatory bowel disease. Specifically, he is interested in improving health outcomes, health-related quality of life, and quality of care. His research includes the role of vaccination in preventing infection, IBD disease phenotype and classification, and outcomes after surgery. Dr. Melmed oversees clinical trials of novel agents for Crohn's disease and ulcerative colitis. We are seeking a Clinical Research Associate I (CRAI) who 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 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 & 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. Education: High School Diploma required. Bachelor's degree preferred in Science, Sociology or related field. Department-Specific Licenses and Certifications: CA Certified Phlebotomy Technician I (CPT1), required. Experience and Skills: One (1) year of clinical research experience is preferred. Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations. Working Title: Clinical Research Associate I - Melmed Lab Department: Home Dept - Gastroenterology Business Entity: Academic / Research City: Los Angeles Job Category: Academic/Research Job Specialty: Research Studies/Clinical Trials Position Type: Full-time Shift Length: 8 hour shift Shift Type: Day

Los Angeles, California

Southern California HERC, established in 2003, is a non-profit organization composed of a diverse group of colleges and universities, and research, medical, and cultural institutions. Our institutions are committed to diversity, equity, and inclusion in the recruitment process and providing a work environment sensitive to work/life balance. We also understand that employment decisions often involve two careers and offer state of the art dual career resources and solutions. SoCal HERC includes members from the Central Coast, Los Angeles, Orange County, Inland Empire, and San Diego.

HERC is a gateway to more jobs in higher education and related fields than any other website. HERC provides job seekers with comprehensive and transparent access to job opportunities, daily job alerts, career advice news and webinars, dual career support, and regional multicultural resources to help with relocating to a new community.

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Antioch University, Azusa Pacific, University Cal Tech

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Cedars-Sinai Medical Center, Chapman University, Citrus College

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