Job Description
Come join our team! The Clinical Research Coordinator II works independently providing study coordination, including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries. Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties & Responsibilities
• Independent study coordination, including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. • Schedules patients for research visits and procedures. • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug. • Maintains accurate source documents related to all research procedures. • Responsible for accurate and timely data collection, documentation, entry, and reporting, including timely response to sponsor queries. • Schedules and participates in monitoring and auditing activities. • Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. • Notifies direct supervisor about concerns regarding data quality and study conduct. • Works 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 in accordance with local and federal guidelines. • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. • 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 coordinate training and education of other personnel. • May participate in centralized activities such as auditing, Standard Operating Procedure development, etc. • May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency. • May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. • May identify new research opportunities and present to investigators.
Qualifications
Education, Experience, & Certification Requirements:
High School Diploma/GED required. Bachelors Degree in Science, Sociology or related degree preferred. Two (2) years of clinical research related experience required. SOCRA or ACRP certification preferred.
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.