Description

To Co-ordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation • To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. • To Prepare of the CRFs and other working documents, if applicable. • To prepare documents for submission to the regulatory. • Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same. • Internal QC of study documents • Literature Search • To assist Project Manager for feasibility assessment of study proposal. • Literature survey for PK & Safety study. IEC Communication: • Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application. • To prepare documents for submission to the Ethics Committee (EC)

Role and Responsibilities

• To Co-ordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation • To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable. • To Prepare of the CRFs and other working documents, if applicable. • To prepare documents for submission to the regulatory. • Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same. • Internal QC of study documents • Literature Search • To assist Project Manager for feasibility assessment of study proposal. • Literature survey for PK & Safety study. IEC Communication: • Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application. • To prepare documents for submission to the Ethics Committee (EC)