Clinical Trial Associate required at Sun Pharma "A"
Job Description
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
