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Monday, 23 September 2013

Urgent Opening for CRA- Freelancer - Ahmedabad, Karnataka......m

Job Description

CRA – Freelancer
Task
As Monitor: -
1. Study Site Qualification / Initiation / Monitoring / Close-out visit for the sites in the city and in the nearby location accessible by an overnight journey (not more than 10 hours) 
a. Shall plan the visit as per the SOP for Site qualification / initiation / monitoring / close-out
b. To perform the visit as per the requirement of the project and in accordance to the SOP for Site qualification / initiation / monitoring / close-out
c. Prepare Site qualification / initiation / monitoring / close-out visit report and follow up letter
2. Ensure adequate recruitment at site and oversee the conduct of the trial at the site 
3. Ensure proper documentation at site
4. Ensure timely deliverable
5. Manage Trial Master File (TMF) and responsible for reconciliation of the TMF
6. Prepare study documents for assigned studies, e.g. consent and assent templates, site reference materials, site monitoring plan, pharmacy manual
General task:-
1. Do study feasibility for therapeutic indications with investigators and update in Investigator data base
2. Get feasibility from 2 new Investigators per therapeutic indication per month and update in data base
3. Visit the sites in the vicinity at-least every three months to do a general feasibility for updating site status

Requirements

Candidate Sholud having the knowledge regarding the Study Site Qualification / Initiation / Monitoring / Close-out visit for the sites in the city and in the nearby location accessible ,Prepare Site qualification / initiation / monitoring / close-out visit report and follow up letter
 
 
 

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