Clinical Research Coordinator - Multi-Site Trials

Prana Clinical; Stockton (CA); On-site; USD 45,000 - 55,000; Full time

Job summary

Prana Clinical Research seeks a detail-oriented Clinical Research Coordinator to manage Phase 2–4 sponsor studies across multiple sites. You will work with principal investigators, sub-investigators, and study teams to ensure compliant conduct from start-up to close-out.

Responsibilities include regulatory binder maintenance, IRB tracking, patient screening, informed consent, data entry in EDC, monitoring visits, and specimen handling.

Qualifications

• 2+ years as a clinical research coordinator at a research site.
• Hands-on experience with informed consent, EDC data entry, query resolution, and hosting monitor visits.
• Current GCP and IATA/DOT dangerous-goods shipping training.
• Working knowledge of ICH-GCP, 21 CFR Parts 50, 56, and 312, and HIPAA.
• Reliable transportation and a valid driver's license for travel between sites.

Responsibilities

• Coordinate Phase 2–4 sponsor studies across multiple sites with PI and study team.
• Prepare and maintain regulatory binders and essential documents (1572s, CVs, licenses, training logs, delegation logs, IRB approvals).
• Submit IRB documents and track approvals, amendments, and continuing reviews.
• Pre-screen eligible patients; conduct informed consent per GCP and SOPs; schedule visits and collect data.
• Take vitals and record ECGs; collect and process lab specimens per protocol and PI direction.
• Enter data into sponsor EDC within timelines and resolve data queries.
• Host monitoring visits and close out action items; maintain source documents.
• Package and ship specimens per IATA/DOT; track lab kits and supplies; write/refine site SOPs.

Skills

Clinical Research Coordination

Informed Consent

EDC Data Entry

Query Resolution

Monitor Visits

GCP Training

IATA Shipping

HIPAA Knowledge

Driver's License

Travel Between Sites

Tools

EDC Systems

IATA Shipping Procedures

Central Lab Coordination

Job description

Prana Clinical Research seeks a detail-oriented Clinical Research Coordinator to manage Phase 2–4 sponsor studies across multiple sites. You will work with principal investigators, sub-investigators, and study teams to ensure compliant conduct from start-up to close-out.

Responsibilities include regulatory binder maintenance, IRB tracking, patient screening, informed consent, data entry in EDC, monitoring visits, and specimen handling.