• Conduct site monitoring visits (e.g., selection, initiation, regular monitoring, and close-out visits) per contractual scope and regulatory requirements (GCP, ICH).
• Develop and manage recruitment plans with sites to meet project needs.
• Provide protocol training and establish communication channels with site staff.
• Assess site adherence to the study protocol and regulations; escalate quality issues when necessary.
• Track study progress, including regulatory submissions, recruitment, and data management.
• Ensure that site documents are properly filed in the Trial Master File (TMF) and Investigator’s Site File (ISF).
• Maintain detailed documentation of site activities, including visit reports and follow-up correspondence.
• Support project teams as needed and contribute to subject recruitment plans if required.
• Manage site financials and ensure compliance with clinical trial agreements.

Qualifications:

• Education: Bachelor’s degree in a scientific discipline or healthcare-related field preferred.
• Experience: Minimum of 1 year of on-site monitoring experience required; equivalent education/training considered.
• Knowledge and Skills:
  • Understanding of clinical research regulations (GCP, ICH).
  • Proficiency in Microsoft Word, Excel, PowerPoint, and use of mobile devices.
  • Strong communication skills (English proficiency required).
  • Problem-solving, organizational, and time management skills.
  • Ability to work effectively with colleagues, clients, and site staff.

Application Link