In this context, as a client, you expect:
- Positive, results orientated work environment, building partnerships and modeling teamwork,
communicating to the team in an open, balanced and objective manner - Ownership for all project activities, which are related to the monitoring function
- Identification and qualification of potential investigators to ensure that the sites
have adequate time and can fulfill their obligation to the study - Preparation and submission of Regulatory and EC issues or providing support for undertaking Regulatory and EC submissions.
- Site initiation visit including site personnel training and close out visit
- Regular on-site monitoring
- Preparation and submission of visit reports in a timely manner according to mca SOPs or client SOPs as required
- Regular follow-up letters to the investigators and study personnel
- Ongoing training to the site personnel with regards to ICH-GCP guidelines, our mca SOPs,
or the client SOPs to ensure the quality and integrity of the data - Ensuring effective and timely coordination of the supply of clinical materials to the site
- Source data verification, drug accountability and data collection) in accordance with ICH-GCP guidelines,
client policies and SOPs, and regulatory guidelines - Query management, SAE editing
- Etc.