Clinical Trial Assistant Senior
- Support for administrative procedures: request, follow up and final resolutions regarding approvals / authorizations of the initial submission of a study, as well as substantial modifications of Clinical Research, according to legislation and / or Applicable SOPs regarding CEICs, CEIm, AEMPS and CCAA, such as: telephone monitoring, quality control of documents, review of approvals, request for documentation, generation of traceability tables …
- REeC updating
- Preparation of the TMF, ISF and pharmacy file
- Preparation and supervision of the necessary forms for the implementation of the study, as well as the substantial modifications and notifications (Application Form Annex 1 A (Xml), Substantial Modification Form, Form 1D, etc.)
- Review and adaptation to the applicable law of general documents of the study
- Management of the necessary evaluation fees (request, invoice monitoring and payment management)
- Support for the preparation of the document of answers to the clarifications of CEICs, CEIm, AEMPS and CCAA, as well as the adaptation or implementation of changes requested in the essential documents of the study (eg HIP, questionnaires, patient card) in coordination with the team of the Department of Clinical Research or Department of Quality and Documentation assigned.
- Preparation of the transmittal form of the CRDs
- CTA course or experience in a similar position of at least 5 years
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