Clinical Research Coordinator

Fountain Valley, CA (Training will be in Glendale for 6-9 weeks) Overview The Clinical Research Coordinator 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; present this 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). Responsibilities Coordinate assigned protocols independently — prescreen for eligibility, explain non-medical study details to patients, and support the informed consent process Schedule research visits and procedures Document condition changes, adverse events, concomitant medications, protocol adherence, and treatment response on CRFs alongside the investigator and clinical team Maintain complete source records and enter data on schedule, resolving sponsor queries promptly Submit AEs, SAEs, protocol deviations, and safety letters through the regulatory coordinator or directly to the IRB Work to GCP standards and meet FDA, local IRB, and HIPAA requirements Participate in monitoring visits and audits Report protocol activity, accrual, and workload at research staff meetings, and escalation data quality or conduct concerns Develop and execute strategies to increase enrollment and improve site efficiency Support research billing, coordinator training, SOP development, and new study identification as needed Qualifications 2+ years of CRC experience 1+ year of oncology/hematology research experience Ability to travel to satellite offices as needed ACRP/SoCRA (or equivalent) certification preferred. #J-18808-Ljbffr ClinLab Solutions Group