Preparation of Study documents:
- Coordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation
- Prepare Informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and it’s back translation into English, if applicable.
- Preparation of the CRFs and other working documents, if applicable.
- Prepare documents for submission to the regulatory.
- Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same.
Feasibility of the study proposal
- Assist PM for feasibility assessment of study proposal.
- Literature survey for PK & Safety study.
- Coordinate with Principal Investigator (PI) and/or Clinical Investigator (CI) for application
- Prepare documents for submission to the Ethics Committee (EC).
Dose administration activity as required.
Perform any other duties as assigned by line manager.
|Salary||1 Lac To 2 Lac 50 Thousand P.A.|
|Industry||Medical / Health Care / Hospitals|
|Work Experience||1 Years|
|About Company||It is a job consultancy|
|Contact Person||mithil shah|
|Address||e-306 sobo center ,bopal ,ahmedabad|