Clinical Research Associate - Pune, India - Refined Reports Data

Refined Reports Data

Verified Company

Pune, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

develop and write trial protocols (outlining purpose and methodology)
- present trial protocols to a steering committee
- design data collection forms, known as case report forms (CRFs)
- identify and assess the suitability of facilities to use as the clinical trial site
- identify/select an investigator who will be responsible for conducting the trial at the trial site
- liaise with doctors, consultants or investigators on conducting the trial
- set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
- train the site staff to trial-specific industry standards
- monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
- verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
- collect completed CRFs from hospitals and general practices
- write visit reports and file and collate trial documentation and reports
- meet with team members to discuss on-going trials, results and any trends or adverse events
- ensure all unused trial supplies are accounted for
- close down trial sites on completion of the trial
- discuss results with a medical statistician, who writes technical trial reports
- archive study documentation and correspondence
- prepare final reports and occasionally manuscripts for publication.

Job Types:
Full-time, Fresher

Salary:
₹12, ₹28,806.09 per month

Benefits: