Job Description
The Smidt Heart Institute reflects Cedars-Sinais steadfast commitment to heart disease and research innovation, giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons, and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation, and discovery, improving patient outcomes. Join our team and use your experience with an organization known nationally for excellence in research!
The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
Primary Duties and Responsibilities
• Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. • Collects, evaluates, and/or abstracts clinical research data. • May assist in designing forms for data collection/abstraction. • Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. • Completes Case Report Forms (CRFs) • Assists with prescreening of potential research participants for various clinical trials. • Schedules research participants for research visits and research procedures. • Provides supervised patient contact or independent patient contact for long-term follow-up patients only. • Assists supervising staff 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 and patient research billing. • Responsible for sample preparation and shipping and maintenance of study supplies and kits. • Ensures compliance with protocol and overall clinical research objectives. • 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. • May serve as one point of contact for external sponsors for select trials. • May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Qualifications
Educational Requirements:
Licenses:
Experience:
Physical Demands
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.