Clinical Research Coordinator-258798
Medix™ · Walnut Creek, CA
Apply & track with Apply EdgeWe are seeking a detail-oriented and dedicated Clinical Research Coordinator to manage protocol-driven patient visits and drive end-to-end clinical trial operations. Working closely with Principal Investigators, research teams, Study Sponsors, and CROs, you will oversee trial execution, ensure strict regulatory compliance, and deliver high-quality data across all study phases. You will play a vital role in upholding patient safety, ethical enrollment, and accurate clinical documentation to support successful study outcomes.ResponsibilitiesConduct protocol-specified clinical visits and diagnostic procedures, including phlebotomy, IV administration, injections, vital sign collection, and ECG/EKG assessments.Lead patient recruitment initiatives to ethically meet target timelines while managing subject scheduling and conducting visits according to strict protocol timelines.Administer informed consent processes in full compliance with federal regulations, Good Clinical Practice, and Institutional Review Board mandates.Document clinical assessments and trial data into e-source platforms and complete Case Report Forms (CRFs/eCRFs) while maintaining meticulous source documentation.Monitor patient safety by promptly identifying and reporting Adverse Events, and escalating Serious Adverse Events to sponsors within 24 hours while keeping PIs, Sub-Investigators, and leadership fully informed.Oversee trial supply chain and inventory, accounting for and ensuring the constant availability of investigational drugs, lab supplies, and CRFs.Maintain ongoing, structured communication with study leads, managers, investigators, and sponsor delegates to ensure cross-functional alignment and protocol adherence.Ensure absolute patient confidentiality compliant with HIPAA requirements, performing all clinical duties safely and cost-effectively in accordance with institutional policies.Required SkillsBachelor’s degree in a relevant field or commensurate hands-on clinical research experience.Strong functional knowledge of clinical trial execution, including medical terminology, lab collection/processing/storage procedures, and electronic e-source/eCRF reporting systems.Deep understanding of regulatory standards, including ICH, FDA, and GCP guidelines.Demonstrated critical thinking, high-level organizational skills, and acute attention to detail in fast-paced clinical environments.Exceptional communication and interpersonal abilities to interact professionally with PIs, research staff, CROs, study sponsors, and patient populations.Advanced proficiency with personal computers and Microsoft Office Suite.Preferred Skills1+ years of direct experience working as a Clinical Research Coordinator.Practical clinical experience performing phlebotomy, IV starts, and ECG/EKG procedures.