Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days

Job Description Grow your career at Cedars-Sinai! Cedars-Sinai Medical Center has been named to the Honor Roll in U.S. News & World Report’s “Best Hospitals 2024-2025” rankings. At Cedars-Sinai, we take pride in hiring the best, most hard-working employees. Our dedicated doctors, nurses and staff reflect the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a dynamic, inclusive environment that fuels innovation and the gold standard of patient care we strive for. What will you be doing in this role? 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. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or 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 Duties & 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. Qualifications Education, Experience, & Certification Requirements : High School Diploma / GED required. Bachelor's Degree in Science, Sociology or related degree preferred. Two (2) years of clinical research related experience required. SOCRA or ACRP certification preferred. Experience with gene therapy clinical trials and pediatric populations preferred. Experience with clinical trial budgeting and regulatory for FDA-regulated therapeutics preferred. 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 one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the Team 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. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 13260 Working Title : Clinical Research Coordinator II - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days Department : Research - Pediatrics 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 : $58,864.00 - $100,068.80