Cedars-Sinai
Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site,
Cedars-Sinai, California, Missouri, United States, 65018
Overview
Clinical Research Coordinator I - Emergency Medicine - Torbati Lab - Full-Time, On-Site, Days
at Cedars-Sinai. This role involves independent study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsibilities include accurate and timely source documents, data collection, documentation, entry, and reporting, including timely responses to sponsor queries. You will compile and report on each study, including information related to protocol activity, accrual data, workload, and other research information, and present study information at regular research staff meetings. Ensure compliance with all federal and local agencies including the FDA and local IRB. Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and participating in the informed consent process. Schedule patients for research visits and procedures. Document thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug in collaboration with the physician and other medical personnel. Maintain 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. Schedule and participate in monitoring and auditing activities. Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notify direct supervisor about concerns regarding data quality and study conduct. Work closely with a regulatory coordinator or directly with IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. May perform other regulatory/IRB duties, budgeting duties, and assisting with patient research billing and reconciliation. Maintain research practices using Good Clinical Practice (GCP) guidelines and maintain patient confidentiality according to HIPAA regulations and applicable law. Participate in required training and education programs. Qualifications
Educational, Certification, and Experience Requirements: High School Diploma/GED required. Bachelor’s Degree in Science, Sociology or related degree preferred. SOCRA or ACRP Certification preferred upon hire One (1) year of clinical research related experience required About Us
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of a diverse region, with standards in quality, patient care, research, teaching and community service.
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Clinical Research Coordinator I - Emergency Medicine - Torbati Lab - Full-Time, On-Site, Days
at Cedars-Sinai. This role involves independent study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsibilities include accurate and timely source documents, data collection, documentation, entry, and reporting, including timely responses to sponsor queries. You will compile and report on each study, including information related to protocol activity, accrual data, workload, and other research information, and present study information at regular research staff meetings. Ensure compliance with all federal and local agencies including the FDA and local IRB. Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and participating in the informed consent process. Schedule patients for research visits and procedures. Document thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug in collaboration with the physician and other medical personnel. Maintain 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. Schedule and participate in monitoring and auditing activities. Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notify direct supervisor about concerns regarding data quality and study conduct. Work closely with a regulatory coordinator or directly with IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. May perform other regulatory/IRB duties, budgeting duties, and assisting with patient research billing and reconciliation. Maintain research practices using Good Clinical Practice (GCP) guidelines and maintain patient confidentiality according to HIPAA regulations and applicable law. Participate in required training and education programs. Qualifications
Educational, Certification, and Experience Requirements: High School Diploma/GED required. Bachelor’s Degree in Science, Sociology or related degree preferred. SOCRA or ACRP Certification preferred upon hire One (1) year of clinical research related experience required About Us
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of a diverse region, with standards in quality, patient care, research, teaching and community service.
#J-18808-Ljbffr