THE ROLE OF CLINICAL RESEARCH CONSULTANT IN CLINICAL TRIALS
Clinical Research Consulting companies provide a complete range of services for clinical research to the clinical divisions of the industries working in field of pharmaceutical and biotechnology industry these specialize in:
- Clinical Monitoring
- Clinical Research
- Project Management
- Clinical Research Coordinator Training & Education
It is extremely aware of the value of academic investment and is aware of the experience required in the clinical research community. Crimson Clinical Research consultant is highly trained for the successful execution of research for achieving the stellar results that are mandatory for the FDA submission.
A clinical research associate is required to have a graduate or post-graduate degree in either of the fields
- life sciences
- medical science
One needs to have knowledge of a minimum of the following subjects
A post-graduate course in the clinical research program also help in gaining more knowledge of clinical trials and provides a competitive edge while looking for employment.
Without a graduate degree getting employment in this profession is almost impossible. One may get a job in administrative duties but for that too one has to pursue specific courses in clinical research.
In the simple words role of the clinical research consultant can be wrapped up as – the coordination of collection, distribution and storage of data which has been obtained during clinical trials. The following responsibilities are involved in successful execution of his role
- Developing and writing clinical trial protocols
- Development of forms and templates for the collection of data
- Coordination with Ethics committee for ensuring that the trials are conducted in an ethical manner
- Setting up of trial sites to ensure trials are conducted following procedures and regulations
- The doctors and the patients are educated regarding the trials
- Monitoring of the conduct of trials at numerous sites and reviewing of data for regulatory submissions
- Preparation of reports, manuscripts and presentations for publications
The role and responsibilities of a Clinical Research Consultant are not just limited to one department, location or a site. Being a CRC involves working with a huge number of people and in various setups.
CRCs can get employed within Clinical Research Organizations, pharmaceutical and biotechnology companies and sporadically in hospitals.
As the clinical trials are carried out on different levels and sites so one has to be skilled to face various challenges, therefore these additional abilities come in handy:
- Excellent communication skills are essential to for talking to and educating different people. Therefore, excellent oral and written skills are essential.
- Attention to detail and data analysis because one is dealing with the Regulatory authorities for the approval or rejection of drugs that is based on trial data
- Organizational and time management skills are of paramount
- Good IT and administrative skills for handling and reviewing of the data through computer processes.