Clinical Research Coordinator

10 hours ago


Swansea, City and County of Swansea, United Kingdom Cyden Ltd Full time
Job Title: Study Monitor

Job Summary:

We are seeking a highly skilled Study Monitor to join our Clinical and Application Research Team at Cyden Ltd. The successful candidate will be responsible for overseeing the progress of clinical and application research/trials, ensuring compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.

Key Responsibilities:

  • Oversee the progress of clinical and application research/trials
  • Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
  • Provide a global evaluation of all investigations commissioned and executed
  • Assist in preparing study documentation for trials, IRB/IEC submissions, and regulatory dossiers
  • Conduct on-site training and motivate investigators
  • Ensure accurate data is recorded across multiple investigations and verify patient data
  • Maintain all files pertaining to clinical trials, track study progress, and ensure timely quality updates are provided
  • Perform routine site visits and assessments
  • Ensure all projects run optimally, and work is completed correctly and within designated timelines
  • 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
  • Experience working in a similar role
  • Excellent organisational, planning, and interpersonal skills
  • 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

What We Offer:

Cyden Ltd offers a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to attracting and retaining top talent and offer a competitive salary and benefits package.



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