Clinical Research Coordinator

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

Company Description

Prana Clinical Research is a multi-specialty clinical research network conducting industry-sponsored clinical trials across multiple therapeutic areas. We're looking for a Clinical Research Coordinator with strong attention to detail who learns quickly and brings the

experience and knowledge to perform the role with integrity. As a growing network, we offer real ownership and exposure to every stage of a study, from start-up through close-out.

Role Description

You’ll coordinate Phase 2–4 sponsor studies across our sites, working with principal investigators, sub-investigators,

and other members of the study team.

Study start-up and regulatory

• Prepare and maintain regulatory binders and essential documents (1572s, CVs, licenses, training logs, delegation logs, IRB approvals and correspondence).
• Support site qualification and initiation visits; complete feasibility questionnaires with the PI.
• Submit IRB documents and track approvals, amendments, and continuing reviews.

Participant recruitment and visits

• Pre-screen eligible patients against protocol criteria.
• Conduct and document informed consent per GCP and site SOPs.
• Schedule and run study visits: collect questionnaires, coordinate procedures, dispense and account for investigational product per protocol and PI direction.
• Take vitals and record ECGs after training, when delegated by the principal investigator.
• Collect and process lab specimens; venipuncture only if you hold a current California CPT certificate.

Data and quality

• Enter data into sponsor EDC systems within required timelines; resolve queries.
• Maintain source documents that hold up to monitoring and audit.
• Report adverse events and protocol deviations to the PI promptly.
• Host monitoring visits and close out action items.

Site operations (Not limited to)

• Package and ship specimens to central labs, including dry ice shipments, per IATA/DOT dangerous-goods requirements.
• Prepare and track lab kits; flag expiring kits and low supplies.
• Record collection and processing times, centrifuge settings, and freezer/fridge temperatures in study logs.
• Track visit completion for invoicing.
• Help write and refine site SOPs.

Qualifications

Required

• 2+ years as a clinical research coordinator at a research site, running industry-sponsored studies independently.
• 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.

Preferred

• Experience across more than one therapeutic area.
• California CPT-I phlebotomy certificate.
• Bilingual English/Spanish, Punjabi, Hindi, or another language spoken in our patient communities.

What we offer

• $33–$40/hour during the contract term, based on experience.
• Direct work with investigators and company leadership.
• Variety: multiple therapeutic areas and sites rather than a single study.
• A role that grows with the network as we add studies and sites.

How contract-to-hire works

This role begins as a contract position, with the opportunity to convert to a regular position based on performance and business needs.

Location

On-site within the Stockton, Lodi, Manteca, Tracy, and Modesto area with opportunity to work in multi-specialty clinical trials.