Posted:6 days ago|
Platform:
Work from Office
Full Time
A. Preparation of Protocols, Informed Consent Documents, Case Report Forms, and other protocol related documents as per applicable regulatory requirements in consultation with Group
In-charge, Principal Investigator, Biostatistician, Analytical Investigator, and Head of the department.
B. Coordination with study personnel and other departments for protocol related issues for finalization of protocol.
C. Approval of protocols from Ethics committee in consultation with Principal Investigator and Sponsor.
D. Translation of Gujarati Informed Consent Documents from English to Gujarati.
E. Responsible for updating the protocol related concerns to investigator(s), sponsor and Ethics Committee.
F. Preparation and revision of related SOPs.
G. Conforms to training schedule for own position and maintains awareness of SOPs contents according to company requirements.
H. Stays current with the ongoing changes in the pharmaceutical regulatory environment,
i.e. FDA, GCPs, GLPs, etc.
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