Senior Clinical Research Coordinator - On-Site Denton

Revival Research Institute, LLC; Richardson (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

Revival Research Institute, LLC is seeking an experienced site-based Clinical Research Coordinator to manage interventional trials from initiation to close-out. The role requires independent consent, on-site visit execution, and data capture in sponsor-defined timelines.

The candidate should have 2+ years of site-based coordination experience, proficiency with EDC platforms, and strong knowledge of ICH-GCP E6(R3) and related FDA regulations. On-site work in Denton, Texas is required.

Qualifications

• 2+ years as a Clinical Research Coordinator at a trial site, leading interventional studies.
• Demonstrated ability to obtain informed consent for interventional protocols independently.
• Hands-on experience with EDC platforms.
• Experience hosting monitoring visits and addressing monitoring findings independently.

Responsibilities

• Screening, recruitment, and enrollment of participants per protocol and criteria.
• Collect, process, and ship specimens when applicable, including IATA shipments.
• Enter data into EDC within sponsor timelines and resolve data queries.
• Drive regulatory document management and ensure inspection-ready files at all times.
• Communicate with sponsors, CRAs, labs, and vendors; prepare regulatory submissions and deviations as required.
• Oversee IP receipt, dispensing, and accountability per protocol and sponsor requirements.
• Maintain up-to-date knowledge of ICH-GCP E6(R3) and FDA regulations; complete required training.

Skills

ICH-GCP knowledge

HIPAA knowledge

Strong communication

Independent protocol handling

Education

Master's degree in health-related field

Tools

EDC platforms

Job description

Revival Research Institute, LLC is seeking an experienced site-based Clinical Research Coordinator to manage interventional trials from initiation to close-out. The role requires independent consent, on-site visit execution, and data capture in sponsor-defined timelines.

The candidate should have 2+ years of site-based coordination experience, proficiency with EDC platforms, and strong knowledge of ICH-GCP E6(R3) and related FDA regulations. On-site work in Denton, Texas is required.