Even as drug regulators the world over are becoming more stringent in scrutinising clinical trials, associations of large pharmaceutical companies in the United States, Europe and Japan have come out with a uniform disclosure code for the clinical trials sponsored by them.

The disclosed information will include a short description of the clinical trials in layman’s terminology, its phase, its purpose, condition of disease, location of trial and contact details of the investigators.

The data of all such trials, irrespective of where they take place, will be made available online within a specified time frame. The companies will carry out these disclosures even if a country’s regulations do not mandate such disclosures.

Essential Function
To support the Clinical Research Associate (CRA) team and / or Clinical Leads according to Task Order Matrix throughout the complete conduct of the study by documenting information concerning the progress of clinical trials such that it is always complete, up to date and available to team members, sponsors and auditors. To help communicate and follow up on actions between clients, sites, team members and other members of the project team and to be viewed by the CRAs and CLs as an important source of project information and assistance.

The much-awaited Biomedical Research Human Subjects Promotion and Regulation Bill for monitoring the booming clinical trial industry in the country, will be introduced in the Budget session of Parliament for its final seal. The Parliamentary committee attached to the Union Health Ministry is examining the subject and is expected to submit the draft to the Ministry in two months’ time.

According to sources in the Union Health Ministry, the Bill will be introduced in Parliament some time in January. “The Parliamentary committee is examining the draft bill and it will submit the final draft to the Ministry by December”, a top Health Ministry official said.

Description

The CRA conducts monitoring visits for assigned protocols and study sites. Overall responsibilities are to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

- Performs site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.

Job available for CRA with atleast two years experience in conducting trials for a position based in Bangalore. Please contact admin@vaatsalya.com with details.