Clinical Research Coordinator I - Nurse

Iterative Health•Tyler, TX

About The Position

Iterative Health is a healthcare technology and services company focused on accelerating clinical research to improve patient outcomes. The Iterative Health Site Network is a leading network of over 80 global clinical research sites dedicated to advancing gastrointestinal (GI) and hepatology novel therapies. The company empowers its partner sites with tech-enabled services to drive success and growth. By integrating deep clinical trial expertise with advanced AI, Iterative Health supports research teams and study sponsors in expanding and expediting patient access to new treatments. This role is for a full-time, experienced Clinical Research Coordinator - Nurse who will support, facilitate, and coordinate daily clinical trial activities, playing a crucial role in study execution.

Requirements

  • RN license required
  • 1-3 years of Clinical Research Coordinating experience preferred

Responsibilities

  • Communicate study requirements to all individuals involved in the study.
  • Develop and implement recruitment strategies in accordance with GI Alliance RESEARCH and IRB requirements and approvals.
  • Pre-screen and screen subjects for eligibility using protocol-specific inclusion and exclusion criteria.
  • Enter participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding sources.
  • Maintain adequate inventory of study supplies. Follow sponsor protocol and/or GI Alliance RESEARCH Policy on Investigational Drug/Device Accountability when handling investigational drugs/devices.
  • Complete study documentation and maintain study files in accordance with sponsor requirements and GI Alliance RESEARCH policies and procedures, including consent forms, source documentation, narrative notes, case report forms, and investigational material accountability forms.
  • Maintain effective and ongoing communication with sponsor, research participants, site manager, Regional Director, and PI during the course of the study.
  • Manage the day-to-day activities of the study, including problem-solving, communication, and protocol management.
  • Collect and report ongoing patient recruitment/enrollment metrics to the site manager and PI.
  • Arrange secure storage of study documents to be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
  • Protect the rights and welfare of all human research participants involved in research in accordance with Federal regulations.
  • Cooperate with GI Alliance RESEARCH compliance and monitoring efforts regarding the access, use, and disclosure of PHI and report instances of noncompliance to the appropriate compliance office.
  • Perform other duties as assigned.
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