Clinical Research Coordinator

2 months ago

Swansea, City and County of Swansea, United Kingdom Cyden Ltd Full time
Job Summary

Cyden Ltd is seeking a highly skilled and experienced Study Monitor to join our Clinical and Application Research Team. As a Study Monitor, you will play a critical role in ensuring the successful execution of clinical trials and application research projects.

Key Responsibilities
  • Oversee the progress of clinical and application research/trials, ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.
  • Provide a global evaluation of all investigations commissioned and executed, identifying areas for improvement and implementing corrective actions.
  • Assist in preparing study documentation for trials, IRB/IEC submissions, and regulatory dossiers, ensuring accuracy and completeness.
  • Conduct on-site training and motivate investigators, ensuring they are equipped to conduct trials effectively.
  • Verify patient data and ensure accurate data recording across multiple investigations.
  • Maintain all files pertaining to clinical trials, track study progress, and ensure timely quality updates are provided.
  • Perform routine site visits and assessments, ensuring compliance with protocol, GCP, and internal SOPs.
  • Bridge the gap between the Principal Investigator and research personnel, providing vital advice and making informed decisions.
  • Ensure Routine Close-out activities are completed and audit all activities undertaken at each investigative site.
Requirements
  • Strong interest in clinical trial and application research, with experience working in a similar role.
  • Excellent organisational, planning, and interpersonal skills, with the ability to work under pressure and demonstrate initiative and problem-solving skills.
  • Knowledge of clinical trials regulations, ICH-GCP, and excellent literacy, numeracy, and IT skills.
  • Ability to manage multiple priorities and communicate effectively, with a strong sense of due diligence and attention to detail.

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