Job Description
The Smidt Heart Institute reflects Cedars-Sinais steadfast dedication 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 niche 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 a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation, and discovery, improving patient outcomes.
Are you ready to be a part of breakthrough research?
The Clinical Research Coordinator III 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 oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and 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 Job Duties and 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. • 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. • Works with Training and Education Coordinator to ensure all staff is properly trained and certified. • Participate in centralized activities such as auditing, Standard Operating Procedure development, etc. • Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency. • Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. • Identifies new research opportunities and presents to investigators. • Supervises other research staff.
Qualifications
Education: High School Diploma/GED required. Bachelors degree in Science, Sociology, or a related field preferred.
License/Certification: Certification in Clinical Research from ACRP/SOCRA is preferred.
Experience: Four (4) years of clinical research related experience is required.
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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.