Clinical Research Coordinator

About this role

• **About Prana** Prana Clinical Research is a multispecialty 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.
• **What you'll do** 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** * 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.
• * Manage study supplies.
• * Track visit completion for invoicing.
• * Help write and refine site SOPs.
• **What you bring** **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.
• Prana Clinical Research Equal Opportunity Employer Page 1 **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** * CCRC (ACRP) or CCRP (SOCRA) certification.
• * 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.
• **Location** On-site within the Stockton, Lodi, Manteca, Tracy, and Modesto area, with travel between sites.
• **How to apply** Click **Apply** on this posting.
• In your resume or cover letter, list the studies you've coordinated (phase and therapeutic area) and how many you managed at once.
• Pay: $33.00 - $40.00 per hour Expected hours: 40.0 per week Work Location: In person

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