The Pharmaceutical and Biotechnology industry boom is generating more career opportunities for clinical research professionals who trained to help bring the novel drug treatments. There are huge job opportunities available in the clinical research area and the demand increases as the drug pipelines expand.

Apart from the doctors who study the effects of the new drug therapies on subjects, Clinical trials require various other professional to make sure trials are conducted as per guidelines provided by ICH or specific regulatory bodies like US FDA, HSA,TGA, MHRA etc. One of them is Clinical Research Associate.

Supervising the Clinical Trial

To become Clinical Research Associate (CRA) individual should have bachelor’s degree in Life science like Pharmacy, Biology or bachelor’s degree in nursing or physiotherapy. CRAs job responsibility is to make sure investigational site personnel performing the study as per Good Clinical Practice (GCP) guidelines, and also CRA ensure that investigational site complies with all appropriate regulatory specifications. They also monitor adverse events, evaluate the reliability of drug accountability records and carry out other administrative responsibilities.

The CRA is the supervisor for the sponsor of the clinical trial,” says senior CRA from leading CRO. CRAs are generally hired by sponsors which may be pharmaceutical or Biotech companies, Clinical Research Organisations and Medical device firms.

CRA travel from one site to another site. CRA professionals with minimum three years of relevant experience can expect to make median annual salaries of around $100,000 a year, according to industry professionals. The next stage for a CRA is generally a project management role that will pay more and provides more liability for managing trials.

CRA Education and Training:

To become a Clinical Research Associate individual must have bachelor’s degree in medicine, nursing or life science like Pharmacy, Pharmacology, Anatomy, Physiology,  Biology, Chemistry, Biomedical sciences, Molecular biology, Immunology, Toxicology . PG diploma and advanced diploma in clinical research which provides experience in clinical research and also offer an advantage over competition for jobs.

Industry experts says ” healthcare professionals who want to shift their profession into clinical research , joining in a professional institutes could provide you better understanding of clinical research and also offer you networking opportunity that can guide you to get well paid position in the clinical research field.

Skills Required to Become CRA

• Excellent communication skills
• Good organisational skills
• Through knowledge of ICH GCP and other regulatory authorities guidelines to conduct clinical trials
• Logical thinking
• Commercial awareness
• Ability to work individually

Job Duties of Clinical Research Associates

• Preparing clinical trial reports
• Preparing drug trial procedures
• Developing trial materials and distributing to study centers with adequate quantities
• Giving clinicians with guidelines on how to perform the specific trials
• Gathering and authenticating Case Report Forms
• Overseeing progress throughout the duration of the clinical trial

Who Hire of Clinical Research Associates

• Clinical Research Organisations
• Pharmaceutical Companies
• Biotechnology Companies
• Device manufacturing companies
• Medical centers
• Hospital academic departments

Career Path after Clinical Research Associate 

• CRA I
• CRA II
• CRA III
• Senior CRA
• Project Management

Pay Scale for Clinical Research Associate According to Industry Experts (Per Annum)