Clinical Research Associate Training | Jobs In Pune The way medical research is being done and the need to develop new drugs are changing like never before. Working as a Clinical Research Associate (CRA) is a very exciting and stimulating job. This site is to enhance your knowledge regarding CRA trainings forwarded by CRB Tech .
There is no such thing as a standard day in the role a CRA because being a significant part of an organization every days sees a new challenge.
A Clinical Research Associate (CRA) is a health-care professional and very knowledge-intensive. The experts find their place in various organizations related to pharmaceuticals and medicine, in both private and government sectors.
A clinical research associate (CRA) runs clinical trials to test drugs for their effectiveness, risks and benefits to ensure they are safe to allow on to the market. They may work on new as well as existing drugs and are usually employed by either a pharmaceutical company or a contract research organization (CRO) which works on behalf of pharmaceutical companies.
The CRA will typically be involved in all stages of the clinical trial, including identifying an investigation site and setting up, initiating, monitoring and closing down the trial.
Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects.
The responsibilities are assigned by the employer as per organization policies; but typically includes:
- develop and write trial protocols and present trial protocols to a steering committee
- design data collection forms, known as case report forms (CRFs)
- coordinate with the ethics committee
- identify and assess the suitability of facilities to be used as the clinical trial site and a proficient investigator
- set up the trial sites and monitor the trial throughout its duration
- 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
- 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
In simple words, a Clinical Research Associate is the soul of the organization.
To become a clinical research associate (CRA) you need to have either a degree or postgraduate qualification in nursing, life sciences or medical sciences.
The skill sets you need to have for a CRA are :
- excellent communication skills (both written and oral) and the ability to build effective relationships
- accuracy with numbers and detail oriented
- multitasking and decision maker
- good organizational, IT and administrative skills
In addition, you must understand the importance of good clinical practice (GCP), which is now law throughout the world. A clean driving license is usually essential for travel between trial sites and your office.
In India, a CRA requires to gain knowledge about schedule Y amendments in drug and cosmetic act 1945.
|Qualification||Bachelor’s or master’s degree|
|Job Skills||Highly organized, analytical, decision maker,problem-solving, maths and statistical knowledge|
Jobs In Pune
With the many ongoing progressive researches in Pune, the demand of a CRA is increasing.
In the race of many institutes and organizations CRB Tech Solutions has it own name in offering Clinical Research Training.
Clinical Research review by CRB Solutions is sufficient to make you consider and take up a career in this field.