Paris
Hello,
Please find below my personal abilities to manage a clinical trial:
- Conduct and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation.
- Perform all clinical monitoring tasks and/or remote visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and data integrity at all times.
- Act remote contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. This includes managing/supporting site activities remotely, resolving site issues, and ensuring timely/high quality data entry at a site level.
- Basic knowledge in Oncology and good practise in Gastroenterology area
Mes compétences :
Monitoring
Essais cliniques
Recherche clinique
