[Remote] Clinical Research Coordinator II (Remote) Per Diem - 6 months TEMP

Note: The job is a remote job and is open to candidates in USA. Cedars-Sinai is a leading healthcare organization, and they are seeking a Clinical Research Coordinator II to work independently on study coordination. The role involves screening patients for eligibility, managing data collection, and ensuring compliance with regulatory standards. 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 • Participates in required training and education programs Skills • High School Diploma/GED required • 2 years Clinical research related experience required • Bachelor's Degree Science • Technical proficiency with clinical trial management systems and databases • Strong organizational and time-management skills • Good understanding of medical terminology • High attention to detail and accuracy Company Overview • 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 for quality and innovation in patient care, research, teaching and community service. It was founded in 1902, and is headquartered in Los Angeles, California, USA, with a workforce of 10001+ employees. Its website is Apply tot his job