Site Cra

**Site CRA - Consumer Research**

Department Consumer Research

Designation Officer / Sr. Officer

Basic qualification required B. Pharm / M. Pharm / M. Sc

Experience 2 - 4 Years

Location Ahmedabad

Brief JD Identify and qualify potential investigators
Responsible for identification & collection of necessary
documents in order to check the feasibility of site/
investigator and approval from authorities.
Responsible for training of site study team, recording &
maintenance of essential documents and for startup
activities & site initiation.
Conduct of monitoring visits to check compliance with
study management, protocol & other requirements at all
assigned sites.
Perform source document verification as per monitoring
plan and ensure that source documents & other trial
records are accurate, complete, kept up-to-date &
maintained according to applicable SOP's to avoid
incomplete records.
Responsible for study updates & Coordination with Labs &
other trial related services as per the study requirements.
Responsible for IP accountability and availability, tracking
and management of all Clinical Trial related supplies
shipped to the sites/ warehouse & accordingly clinical trials
supplies vendor management for the study.
Responsible for site-closeout & follow up activities in order
to maintain documents at the site.
Assist with the audit of an investigational site or central
files and liase with Quality Assurance personnel as required
to ensure that the study is being conducted in accordance
with ICH GCP and applicable regulatory guidelines.