A Clinical Research Associate is a professional who administers and monitors the progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor.
A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.
Clinical Research Associate plays an important role in Biopharmaceutical companies, Medical Device Companies and Contract Research Organizations in dealing with Design, monitor and management of clinical trials.
This program covers all the topics pertaining to clinical trials starting from understanding the Drug development process, study initiation, study monitoring study close out and Regulatory requirements in compliance with FDA and ICH-GCP guidelines.
Upon completion of this course the candidate will be knowledgeable and skillful to get entry-level positions like CRA, Clinical Data Manager Specialists, Clinical Quality Assurance Specialists and Clinical Marketing and Management specialists
The healthcare industry is expanding at a rapid pace. The market is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most of the skills and knowledge required in positions such as CRAs, Clinical Data Managers (CDMs), Quality Assurance (QAs) and Marketing Managers are not covered in university courses.
Even where an individual has been through a specially designed training program for the position through an academic institution, the training may not involve a practical component in which case the individual still lacks certain skills. This should re-emphasize the importance of practical training programs for the biopharmaceutical industry.
No comments:
Post a Comment