Cedars-Sinai
Clinical Research Coordinator II (Hybrid)
Cedars-Sinai, Beverly Hills, California, United States, 90211
Clinical Research Coordinator II (Hybrid)
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Clinical Research Coordinator II (Hybrid)
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Cedars-Sinai This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area. Overview
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. Primary 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. Schedules patients for research visits and procedures. Documents 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. 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. Compiles and reports on each study including protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings. Notifies supervisor about concerns regarding data quality and study conduct. Works with regulatory staff/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. Maintains compliance with federal and local agencies including the FDA and IRB; adheres to Good Clinical Practice (GCP) guidelines and HIPAA requirements. May coordinate training and education of other personnel; may participate in centralized activities such as auditing and SOP development. May plan strategies for increasing patient enrollment and improving clinical research efficiency; identify quality and performance improvement opportunities and collaborate with staff to develop action plans. May identify new research opportunities and present to investigators; participates in required training and education programs. Qualifications
Requirements: High School Diploma/GED required. 2 years clinical research related experience required. Preferred Skills: Bachelor's Degree in Science, Sociology, or related field preferred. 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. Other : Req ID: 11750 Working Title: Clinical Research Coordinator II (Hybrid) Department: Cancer - SOCCI Clinical Research Business Entity: Cedars-Sinai Medical Center Job Category: Academic / Research Job Specialty: Research Studies/ Clin Trial Overtime Status: EXEMPT Primary Shift: Day Shift Duration: 8 hour Base Pay: $28.30 - $48.11
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Join to apply for the
Clinical Research Coordinator II (Hybrid)
role at
Cedars-Sinai This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area. Overview
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. Primary 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. Schedules patients for research visits and procedures. Documents 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. 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. Compiles and reports on each study including protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings. Notifies supervisor about concerns regarding data quality and study conduct. Works with regulatory staff/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. Maintains compliance with federal and local agencies including the FDA and IRB; adheres to Good Clinical Practice (GCP) guidelines and HIPAA requirements. May coordinate training and education of other personnel; may participate in centralized activities such as auditing and SOP development. May plan strategies for increasing patient enrollment and improving clinical research efficiency; identify quality and performance improvement opportunities and collaborate with staff to develop action plans. May identify new research opportunities and present to investigators; participates in required training and education programs. Qualifications
Requirements: High School Diploma/GED required. 2 years clinical research related experience required. Preferred Skills: Bachelor's Degree in Science, Sociology, or related field preferred. 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. Other : Req ID: 11750 Working Title: Clinical Research Coordinator II (Hybrid) Department: Cancer - SOCCI Clinical Research Business Entity: Cedars-Sinai Medical Center Job Category: Academic / Research Job Specialty: Research Studies/ Clin Trial Overtime Status: EXEMPT Primary Shift: Day Shift Duration: 8 hour Base Pay: $28.30 - $48.11
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