Clinical Research Coordinator II

Headlands Research•Escondido, CA

3d•Onsite

About The Position

Headlands Research is hiring a full-time, onsite Clinical Research Coordinator II for AMCR Institute in Escondido, California. AMCR Institute conducts patient-centered clinical trials in metabolic and immunologic research, including studies involving pre-diabetes, type 1 and type 2 diabetes, obesity, NAFLD/MASH, and vaccines. The site works with sponsors and CROs and emphasizes participant care, safety, confidentiality, careful study execution, multidisciplinary collaboration, and strong operational support. This role suits an experienced coordinator who can independently manage assigned studies and contribute to a collaborative clinical research team. The position is onsite; hybrid and remote work are not available. The California pay range is $73,000–$80,000 USD.

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 a high level of care to study patients and excellent customer service to pharmaceutical clients.
Coordinate assigned clinical trials from site initiation through close-out.
Conduct subject visits and maintain accurate, timely documentation in compliance with protocols and applicable standards.
Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs.
Manage subject recruitment, informed consent, and retention activities.
Enter data into EDC systems promptly and resolve queries.
Report and follow up on adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
Collaborate with investigators, sponsors and 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.