Clinical Studies Coordinator

Position only available on-site in Irvine, CA

We are seeking a highly experienced Clinical Studies Coordinator to lead and execute end-to-end clinical studies supporting FDA submissions (510(k)), pilot and feasibility studies, post-market clinical follow-up, and real-world evidence generation.

This role is hands-on, operational, and strategic. The ideal candidate has deep experience managing medical device and digital health clinical studies, working directly with FDA-facing documentation, IRBs, investigators, CROs, and internal regulatory, engineering, and product teams.

This position plays a critical role in de-risking regulatory submissions, ensuring GCP compliance, and translating clinical evidence into successful regulatory and commercial outcomes.

• Lead the planning, coordination, and execution of clinical studies, including:
• Pilot/feasibility studies
• IDE-exempt and IDE-supporting studies
• Pivotal and non-pivotal studies for FDA 510(k) submissions
• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
• Real-world evidence (RWE) and usability studies
• Develop and manage study timelines, milestones, and deliverables
• Ensure studies are conducted in compliance with GCP, FDA regulations, ISO 14155 and other applicable standards.
• Prepare, review, and maintain clinical documentation for regulatory submissions, including:
• Clinical Study Plans (CSPs)
• Protocols and amendments
• Statistical Analysis Plans (SAPs) (in collaboration with biostatistics)
• Clinical Study Reports (CSRs)
• Ensure audit-ready clinical documentation at all times

• Support subject recruitment and enrollment activities
• Conduct blood draws on study subjects.
• Process blood samples.
• Initiate IV’s when the MD is unavailable.
• Supervise the maintenance of laboratory equipment, including calibration records.
• Maintain clinical staff training documentation.
• Perform other duties or special projects as requested.

• 7 – 10 years of related experience or equivalent combination of education and experience.
• Excellent communication skills (both written and oral).
• Knowledge of clinical databases and data management systems
• Ability to be an integral part of an innovative, fast-paced product development team.
• Ability to manage multiple concurrent studies is essential
• LVN with IV training certificate or RN.

• Bachelor’s degree in Life Sciences, Biostatistics, Health Informatics, Biomedical Engineering
• Experience with clinical studies and interfacing with IRB.
• Clinical research certifications

This position primarily works in an office as well as laboratory environment. It requires frequent sitting, standing and walking. Work in a lab involves potential exposure to blood borne pathogens, as well as needles. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings, walking in the facilities, or processing tissue samples, blood, etc.

Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. Some travel to clinical sites might be required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.