- Prepare and procure documents for clinical dossiers for DCGI and/or USFDA submission; as applicable
- Prepare dossiers for EC submission
- Assist PM in site selection process and document collection
- Facilitate and coordinate with investigator and site for EC submission and approval
- Prepare Confidentiality Disclosure Agreement (CDA), Feasibility Questionnaires and Clinical Study Agreement (CSA) with investigators in collaboration with the project manager
- Get trained on the study and documentation requirements
- Prepare for kick-off meetings to train vendor representatives involved if out-sourced activity for monitoring.
- Prepare presentation and documents and Start up kits for site initiation
- Coordinate with translating and back translating agencies for PIS ICF and other associated documents
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