Clinical Research Associate

Role overview

The Clinical Research Associate will help drive the planning, coordination, and execution of multi-site clinical studies. The position works closely with clinical sites, internal stakeholders, and outside vendors to keep study activities on track and compliant with GCP, FDA, ISO 14155, and other applicable regulations. The role covers study start-up through closeout, with responsibilities spanning site coordination, EDC data quality, and regulatory documentation.

Key responsibilities

• Assist with study start-up, day-to-day execution, monitoring, and final closeout across one or more clinical sites.
• Work with clinical sites, CROs, vendors, and internal cross-functional teams to coordinate study operations.
• Review EDC entries, check CRFs, handle queries, reconcile data, and support centralized data review tasks.
• Maintain trackers, enrollment summaries, dashboards, timelines, and other operational reporting tools.
• Draft, organize, and update key study documents such as protocols, consent forms, CRFs, source materials, training documents, and study reports.
• Oversee TMF records and help with IRB submissions, regulatory paperwork, and inspection preparation.
• Monitor enrollment, patient visits, protocol deviations, adverse events, device issues, and study inventory.
• Support recruitment efforts, prescreening, visit scheduling, registry updates, and clinical research database activities.
• Help coordinate budgets, contracts, vendor work, clinicaltrials.gov filings, and other study-related records.
• Make sure clinical studies follow GCP, FDA rules, ISO 14155, IRB expectations, and internal procedures.

Required background

• A bachelor’s degree in Life Sciences, Health Sciences, Nursing, Public Health, or a closely related discipline.
• At least 2 years of experience in a Clinical Research Associate, Clinical Research Coordinator, or comparable clinical research position.
• Hands-on exposure to clinical study operations, EDC platforms, data review, query handling, and research documentation.
• Solid knowledge of GCP, informed consent, adverse event reporting, protocol deviation management, TMF oversight, and monitoring workflows.
• Prior involvement in study start-up, site coordination, enrollment tracking, and study closeout is preferred.
• CRA credentials such as CCRA, CCRP, or CCRC, along with GCP certification, are preferred.
• Experience in medical device research is preferred, and background in sleep medicine, respiratory medicine, or similar healthcare settings is a plus.
• Comfort using Microsoft Office and EDC systems, plus strong organization, documentation, and communication abilities.
• Capability to manage several studies at once and travel to clinical sites about 30% of the time.

Compensation

Hourly pay is listed at $40 to $50 per hour.

Additional information

This is an onsite contract role based in San Diego, CA. The position is focused on clinical research operations and requires collaboration across multiple sites and teams.