Clinical Research Coordinator

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Full Time Dallas, TX, US

Salary Range: $58,240.00 To $72,800.00 Annually

About Us

At Empathx, we drive equitable access to complex trials at any phase by providing industry-leading patient access, clinical trial management, and analysis across cardiology/nephrology, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline.

Position Summary: The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct of clinical research studies in accordance with the protocol, Good Clinical Practice (GCP), applicable federal and state regulations, and Company Standard Operating Procedures (SOPs). The CRC serves as the primary point of contact for study participants and works closely with the Principal Investigator, Sub-Investigators, Sponsors, and Monitors to ensure studies are conducted safely, ethically, and in compliance with all applicable requirements.

The CRC manages a concurrent portfolio of three or more studies across Phase I–IV trials, including vaccine studies.

Duties and Responsibilities:

• Coordinate and conduct study visits in accordance with the protocol, including obtaining informed consent, collecting source data, and administering study procedures and assessments
• Perform clinical procedures as delegated by the Principal Investigator, including phlebotomy, electrocardiograms (EKGs), vital signs, and Fibro Scan assessments
• Manage the coordination of three or more concurrent studies, prioritizing visit schedules and deliverables across protocols
• Screen, recruit, and enroll study participants; verify eligibility against inclusion/exclusion criteria
• Maintain accurate, complete, and timely source documentation and case report forms (CRFs) for all study participants
• Coordinate study participant scheduling, follow‑up visits, and study‑related procedures with internal staff and external providers
• Collect, process, label, and ship biological specimens in accordance with the protocol and laboratory manual
• Administer and document investigational product/device dispensing, accountability, and reconciliation as delegated by the Investigator
• Identify, document, and report adverse events (AEs) and serious adverse events (SAEs) to the Investigator and Sponsor per protocol and regulatory timelines
• Maintain regulatory binders/eTMF documentation and ensure all required regulatory documents are current
• Prepare for and participate in sponsor monitoring visits, audits, and regulatory inspections; respond to monitor queries in a timely manner
• Enter and query study data into electronic data capture (EDC) systems within required timelines
• Collaborate with the Principal Investigator, Sub-Investigators, and study team to resolve protocol deviations and operational issues
• Maintain working knowledge of assigned protocols, amendments, and the Investigator's Brochure
• Conduct informed consent discussions with prospective participants, ensuring comprehension and voluntary participation prior to enrollment
• Coordinate with sponsors, CROs, and monitors on study start‑up activities (site initiation, IRB/IEC submissions, essential document collection)
• Maintain the study's recruitment and retention plan; track screening, enrollment, and discontinuation metrics
• Order, receive, store, and maintain accountability of study supplies and investigational product per protocol and SOPs
• Ensure proper calibration, maintenance, and documentation of study equipment
• Coordinate participant travel, reimbursement, and stipend processing where applicable
• Complete protocol deviation/violation…