The Clinical Research Coordinator I 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; present this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Manages regulatory files for clinical trials and clinical research projects Initiates study start up by completing regulatory documents from sponsors and CROs Prepares IRB study applications for Rheumatology faculty Prepares annual continuation reviews to the IRB Prepares adverse event and serious adverse event reports to the IRB, sponsor/CRO, and other agencies (FDA) by required timelines. Submits SUSAR reports to the IRB if they meet IRB reporting requirements. Prepares and submits protocol deviation reports and protocol exemption requests to the IRB Prepares protocol amendments for IRB review Constructs informed consent forms for studies using the CSMC IRB template Participates in monitoring and auditing activities Manages clinical research databases, data registries, and specimen repositories Travels to Attune Health to assist with patient recruitment 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. Scheduling of 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 involve 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. Participates in required training and education programs.
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards in quality and innovation in patient care, research, teaching and community service. Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients.Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S. with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Clinical programs range from primary care for preventing, diagnosing and treating common conditions to specialized treatments for rare, complex and advanced illnesses. In addition, Cedars-Sinai serves the community through its Medical Network, which includes the highly rated Cedars-Sinai Medical Group and Cedars-Sinai Health Associates. Cedars-Sinai has consistently been named one of America’s Best Hospitals by U.S. News & World Report, has received the National Research Corporation’s Consumer Choice Award 18 years in a row for providing the highest quality medical care in Los Angeles, and has the longest running Magnet desig...nation for nursing excellence in California. Cedars-Sinai is a leader in the clinical care and research of heart disease, cancer and brain disorders, among other areas. Pioneering research achievements include using cardiac stem cells to repair damaged hearts, developing minimally invasive surgical techniques and discovering new types of drugs to target cancer more precisely. Cedars-Sinai also impacts the future of healthcare through education programs that encompass everything from highly competitive medical residency and fellowship programs to a biomedical science and translational medicine PhD program, advanced training for nurses and educational opportunities for allied health professionals. Most notably, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.