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Clinical Research Coordinator
2 months ago
Job Summary:
Cyden Ltd is seeking a highly skilled Study Monitor to join our Clinical and Application Research Team. As a Study Monitor, you 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
- 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
- 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
- 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, opportunities for professional growth and development, and a competitive salary and benefits package.