- 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.
