Clinical Trial Coordinator

4 days ago

Bendigo, Victoria, Australia NHS Full time
Clinical Trial Coordinator

We are looking for a detail-oriented and organized Clinical Trial Coordinator to join our team at iRhythm.

Main Job Responsibilities

The successful candidate will be responsible for ensuring the smooth operation of clinical trials, from initiation to completion, while maintaining high-quality standards and adhering to regulatory requirements.

This role requires strong organizational and communication skills, as well as the ability to work effectively in a fast-paced environment.

The Clinical Trial Coordinator will report to the Sr. Director of Global Clinical Research Operations and collaborate closely with the clinical research team.

About us

iRhythm is a leading digital healthcare company dedicated to creating innovative solutions that improve patient outcomes.

We prioritize our people and our cutting-edge technologies.

Key Responsibilities:
  • Coordinate clinical trials from initiation to completion, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP).
  • Assist in developing and reviewing trial-related documents, including protocols, informed consent forms, and case report forms.
  • Collaborate with cross-functional teams to ensure seamless trial operations, including vendor management and site selection.
  • Track and analyze trial data, identifying areas for improvement and implementing corrective actions as necessary.
  • Communicate trial status and results to stakeholders, including sponsors, investigators, and study coordinators.
  • Ensure compliance with regulatory requirements and company policies, maintaining accurate records and documentation.
  • Participate in ongoing education and professional development to stay current with industry developments and best practices.

Health Economics Outcomes Research / Real World Evidence:

  • Assist in collecting and analyzing real-world data (RWD) to support HEOR studies and RWE projects.
  • Conduct literature reviews and support the development of health economic models or outcomes research protocols.
  • Collaborate with cross-functional teams to ensure data collection aligns with HEOR and RWE objectives.
  • Support the preparation of study-related documents, including RWE study protocols and HEOR deliverables like cost-effectiveness analyses.
  • Oversee the design and execution of HEOR and RWE studies, ensuring alignment with regulatory and payer requirements.
  • Manage cross-functional teams to deliver HEOR models, RWE analyses, and related publications.
  • Ensure timely delivery of HEOR and RWE deliverables, such as value dossiers, real-world data analyses, and health outcomes reports.
  • Coordinate with stakeholders to integrate RWE findings into clinical development and market access strategies.

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