Job Description
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements! Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world. Ranked among the best in the nation by U.S. News & World Report, our neurosurgeons and neurologists work together with experienced care teams to give patients the most effective treatment possible.
About the Role
This position will support the research programs in Department of Anesthesia and Neurology. The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
The responsibilities of the CRC I member include:
• Accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries. • Compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information. • Presenting study information at research staff meetings. • Ensuring compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board.
Primary Duties and Responsibilities
• Scheduling of research participants for research visits and procedures. • Collaboration with the physician and other medical personnel, documenting thoroughly on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug. • Scheduling and participating in monitoring and auditing activities. • Notifying direct supervisor about concerns regarding data quality and study conduct. • Working closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines. • May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. • Maintaining research practices using Good Clinical Practice (GCP) guidelines. • Maintaining strict patient confidentiality according to HIPAA regulations and applicable law. • Participating in required training and education programs. • Coordinating training and education of other personnel.
Department-Specific Duties and Responsibilities
• Transportation of research medications. • Performing research study-related assessments and questionnaires. • Assisting with prescreening of research participants for various clinical trials. • Attending research meetings and monthly conference calls with sponsors for study updates. • Maintaining organized paper and electronic research files. • Performing all data collection and data entry tasks for department clinical trials. • Assisting with preparing manuscripts, letters, and other research documents as needed. • Responding to sponsors inquiries regarding protocol start-up activities and recruitment. • Performing literature reviews.
Qualifications
Education:
• High School Diploma/GED, required. • Bachelors degree in a Science, Sociology, or related field is preferred.
Licenses/Certifications:
• ACRP/SOCRA certification is preferred.
Experience:
• 1 year of clinical research experience, 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.