Clinical Research Coordinator

1 month ago


Tomball, United States Medix™ Full time

Position Summary:

The candidate will be responsible for coordinating clinical research protocols from study start-up through close-out. This role involves close collaboration with research staff to collect, store, and maintain data in compliance with FDA regulations, International Council for Harmonization (ICH) guidelines, and Good Clinical Practices (GCP).

Responsibilities:

  • Serve as the primary coordinator or collaborate with a research nurse on studies, managing source documents, data collection, data entry, query resolution, financial payment triggers, study close-out, and acting as a liaison with the sponsor/CRO.
  • Assist in identifying potential clinical trial participants, screening them for eligibility, and enrolling them according to the protocol.
  • Coordinate the schedule of events for clinical trial participants, from screening through follow-up, in accordance with the protocol.
  • Collect, verify, organize, and record clinical information and data in electronic data capture (EDC) systems. Abstract data from necessary sources to complete the EDC and resolve queries. Perform related data activities including EDC tracking, validation review, updates, SAE reconciliation, lab data reconciliation, and safety coding.
  • May handle regulatory submissions, requiring a working knowledge of essential documents and IRB requirements.
  • Participate in site feasibility assessments, site qualification visits, site initiation visits, and research-related meetings.
  • Potentially responsible for recruiting clinical trials to the site.
  • May involve patient-facing responsibilities.



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