Clinical Research Consultant or Associate runs clinical trials to test drugs for their effectiveness, risk, and benefits to ensure they are safe to enter the market. There is a list of responsibilities, which clinical research consultant needs to perform. That may be varying from one to another. The main task is to outline the purpose and methodology of the trial. To trial protocols and design data collection forms which are known as Case Report forms. (CRFs).
Coordination is very important for smooth functioning from all the team members. Ordination with the ethics committee that safeguards the safety and rights of the wellbeing. Clinical Research consultant needs to manager regulatory authority applications and approvals that oversee the research of new and existing drugs. Identification and assessing the suitability of facilities to be used as a trial site. Selecting an investigator who will be responsible for the conduct of the trial.
Have proper leasing with doctors or investigators on conducting the trial are important. Set up of the trial sites which ensure each center has the trial materials available. If required train the site staff to trial specific industry standards. Clinical Research consultant needs to monitor the trial throughout the duration that includes visiting the trial sites on regular basis.
To verify the data entered on to CRFs is consistent with patient clinical notes, known as source data verification. To collect completed CRFs from hospitals and general practices and writing visit reports, fill trial documentation and reports. It is better to ensure all unused trial supplies are accounted. It is a duty of Clinical research Consultant to close down the trial sites on completion of the trial.
Clinical Research Consultant needs to discuss results with a medical satisfaction who usually writes technical trial reports. For keeping the archive study documentation and correspondence. Finally, Clinical Research Consultant needs to prepare a final report and occasionally manuscripts for the publication.
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Clinical Research is a Systematic study of pharmaceutical products in human subjects in order to discover or verify the clinical, pharmacological, and/or adverse effects, with the object of determining their safety and efficacy.