Clinical Research Coordinator II

Headlands Research•Escondido, CA

9d•$73,000 - $80,000•Onsite

About The Position

Headlands Research is hiring a full-time, onsite Clinical Research Coordinator II at AMCR Institute in Escondido, California. AMCR Institute conducts patient-centered clinical trials in metabolic and immunologic research, including studies focused on pre-diabetes, type 1 and type 2 diabetes, obesity, NAFLD/MASH, and vaccines. The site emphasizes high-quality study execution, participant care, safety, and confidentiality, supported by experienced investigators and clinical staff, strong operations, and clear SOPs. The coordinator owns assigned studies from site initiation through close-out, delivering excellent care to study patients and service to pharmaceutical clients. The role involves conducting visits and study procedures, ensuring accurate and timely documentation and data, maintaining regulatory and protocol compliance, and collaborating with investigators, sponsors, CROs, laboratories, and internal teams. The position is onsite, with no hybrid or remote opportunities.

Requirements

At least one year of experience managing multiple Phase 2–4 industry-sponsored clinical trial studies as the primary coordinator.
A bachelor's degree, or two years of college in a health-related program, or experience and training in conducting clinical trials with knowledge of ICH GCP.
Strong understanding of FDA regulations, ICH-GCP, and clinical trial operations.
Experience with EDC, IVRS, and clinical research platforms.
Proficiency in medical terminology and clinical documentation.
Strong organizational skills and ability to manage multiple studies.
Clear, professional verbal and written communication skills.
Comfort working onsite in a collaborative clinical environment.

Responsibilities

Provide the highest level of care for study patients.
Deliver excellent customer service to pharmaceutical clients.
Coordinate all aspects of assigned clinical trials from site initiation through close-out.
Conduct subject visits and ensure accurate, timely documentation in compliance with protocols and standards.
Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs.
Manage subject recruitment, informed consent, and retention activities.
Ensure timely EDC data entry and resolution of queries.
Report and follow up on adverse events, serious adverse events, and protocol deviations.
Collaborate with investigators, sponsors/CROs, laboratories, and internal teams.
Prepare for and participate in monitoring visits, audits, and inspections.
Maintain regulatory documentation and ensure training compliance for amendments and systems.
Perform study procedures such as phlebotomy, ECGs, and sample processing, as trained.
Attend investigator meetings and provide cross-functional support as needed.
Maintain working knowledge of protocols, lab manuals, equipment calibration, and inventory.