Lead Clinical Research Coordinator - 255069

Lead Clinical Research Coordinator (CRC)Location: San Jose, CA (on-site)Hours: Monday - Friday, 8am-5pmPay: $35 - $45/hourThis dynamic role is designed for an ambitious Lead CRC with aspirations to transition into management. As the operational backbone of a research department, you will balance hands-on trial execution with strategic leadership, essentially acting as the founding captain of the ship as you build and scale the department.Responsibilities:Review daily schedules and ensure all participant documents, lab kits, and materials are meticulously prepared.Verify existing eSource setups or independently build new frameworks tailored to specific study protocols.Act as the sole on-site coordinator to greet participants, conduct informed consent, answer questions, and perform clinical procedures (e.g., phlebotomy).Manage, organize, and maintain all trial documentation (from participant charts to regulatory binders), ensuring strict adherence to FDA and ICH-GCP standards.Utilize the Electronic Medical Record (EMR) system to pre-screen and identify potential study candidates.Educate clinic physicians and staff on research protocols through engagement initiatives like "lunch-and-learns" to drive internal referrals.Partner closely with new Principal Investigators (PIs), guiding them through clinical research workflows and regulatory responsibilities.As the department grows, take ownership of hiring, training, mentoring, and delegating tasks to junior CRCs.Conduct rigorous internal audits of data and files to ensure absolute accuracy and continuous inspection readiness.Log daily progress into the CTMS (Clinical Trial Management System) and manage investigational products (IP) and clinical supplies.Host monitor visits and interface directly with sponsor representatives.Transition into higher-level management tasks over time, including budget negotiations and contract reviews, directly preparing you for a formal management title. Required Skills:3+ Years of Clinical Research ExperienceAbility to handle complex protocolsAbility to own study entirely from start-up to close outCNS Experience - Highly PreferredPhlebotomy ExperiencePreferred Skills:Prior rating experience is a huge plusLeadership experienceSponsor / FDA Audit experienceSchedule/Shift:Monday - Friday 8:00 - 5:00 (onsite)