Clinical Research Coordinator

The Clinical Research Coordinator (CRC) is responsible for the day‑to‑day coordination and execution of clinical research studies conducted under the Clinical Research Center. This role is patient‑facing and requires hands‑on experience coordinating clinical trials, including participant screening, eligibility determination, study visits, and safety reporting. The CRC will manage 5–10 active studies simultaneously and work closely with Principal Investigators, clinical staff, and research team members to ensure studies are conducted in compliance with protocols, Good Clinical Practice (GCP), and institutional and regulatory requirements. This position requires a minimum of 2 years of direct clinical research coordination experience, beyond monitoring‑only roles. This role will require 5 days-onsite in Orange, CA. Key Responsibilities Study Coordination & Participant Management Coordinate and conduct study visits according to protocol requirements Screen and recruit potential study participants, including medical record review and in‑person assessments Review and confirm participant eligibility and obtain informed consent in accordance with IRB‑approved protocols Serve as a primary point of contact for study participants throughout the study lifecycle Provide ongoing participant education and support during study participation Clinical & Safety Responsibilities Monitor participants for adverse events (AEs) and serious adverse events (SAEs) Accurately document and report AEs/SAEs to investigators, sponsors, and regulatory bodies per protocol and institutional guidelines Collaborate with investigators and clinical staff to ensure participant safety and protocol adherence Study Management & Documentation Maintain complete and accurate study files, including regulatory binders, source documents, and study logs Ensure study documentation is audit‑ready and compliant with GCP, FDA, and institutional policies Manage study timelines, visit schedules, and protocol‑specific procedures across multiple studies Work closely with Principal Investigators, regulatory staff, and clinical teams to support study conduct Coordinate with sponsors, CROs, and internal departments as needed Participate in study meetings, sponsor calls, and monitoring visits Electronic Systems Document study activities and participant data in electronic systems, including EPIC (experience preferred) Ensure accurate and timely data entry and source documentation Required Skills & Experience Minimum of 2 years of hands‑on experience as a Clinical Research Coordinator, including direct study coordination responsibilities Demonstrated experience with: Participant screening and enrollment Eligibility review Strong understanding of GCP, FDA regulations, and human subjects research Excellent organizational, communication, and interpersonal skills #J-18808-Ljbffr Insight Global