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Project Management Depart

Ahmedabad-Memnagar-380052, Gujarat, India
05/25/2015

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Required Skills

iec, pi, ci, qc, qa, br

Company

Aarna Consultancy.

Experience

2 to 4 Year(s)

Job Description

1) 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
2) Feasibility of the study proposal
Assist PM for feasibility assessment of study proposal.
Literature survey for PK & Safety study.
3) IEC Communication:

Coordinate with Principal Investigator (PI) and/or Clinical Investigator (CI) for application
Prepare documents for submission to the Ethics Committee (EC).
4) Dose administration activity as required.
5) Perform any other duties as assigned by line manager.
6) Should have excellent written and oral communication skills

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