The safety and efficacy studies on therapeutic, diagnostic or preventive inventions are necessary before their launch into the market. The demand for clinical research professionals is increasing providing better career opportunities to life science students and healthcare professionals.
What is Clinical Research
Clinical Research is a branch of health or medical science that evaluates the safety and efficacy of drugs, medical devices, diagnostic procedures and various other innovative methods of prevention and therapy in humans. The different types of clinical research are: Treatment research involves around testing a new medicine or device or other medical intervention; Preventive research is used to identify preventive methods for various disorders; Diagnostic research refers to identifying a condition or disorder; Screening research aims in detecting certain health conditions or disorders; Quality of life research ensures improvement in quality of life in patients with chronic diseases; Genetic research predicts disorders through genes along with developing treatments based on the genetic make-up; and Epidemiological studies seeks to identify disorders in groups of people. Research studies or experiments conducted in clinical research are called clinical trials.
Job opportunities in Clinical Research
A professional in clinical research needs to have a life science degree but additional degree like computer education is an asset to Clinical data manager; candidate with chemical engineering degree is most suitable for Quality assurance manager while a physician can become a Clinical investigator. An individual with commerce, business management or marketing background finds suitable management or marketing position in clinical research. The process of clinical trial is complex, with each step monitored and recorded by experts. Professionals in this field are skilled in the area of pharmacovigilance, drug development and monitoring, regulation, quality assurance, etc.
The progress of a clinical trial is monitored by Clinical Research Associate or Executive or Monitor or Coordinator or Scientist. They manage trials, organize data and perform all documentation work that involves collection and storage of clinical data. They are involved in all stages or phases of clinical research due to their administrative, management, computation, communication and data analysis skills. Clinical research data manager is involved in medical analysis and coding of data collected from clinical and medical research trials. They ensure that the data collected and reported are clear, accurate and secure. Project managers are involved in planning and managing various aspects of a clinical trial. Their goal is to ensure that in every clinical trial the effectiveness and safety of drugs or pharmaceuticals, medical or diagnostic devices are evaluated in compliance with regulatory guidelines or marketing claims.
Clinical investigator is a licensed practising physician who conducts the trial on patients. A clinical investigator is responsible to conduct every investigation as per the approved investigation plan and applicable regulatory guidelines; for protecting the welfare and safety of patients or subjects; and for monitoring drugs under trial. The investigator generally requires help from in-house or on-site investigation team to conduct trials. Team leaders manage and coordinate between various teams while Directors oversee the smooth running of all the operations in the organisation. Hospitals, pharmaceutical companies, contract research organisation (CRO) and various healthcare organisations also have other positions available like data entry operator, medical writer, data validation executive, etc. A team of professionals with varying skills are needed for conducting clinical trials and many training institutes provide courses and programs for developing such professionals.
Online Course in Clinical Research
James Lind Institute (JLI) provides an online program – Post Graduate Diploma in Clinical research which helps develop more professionals in the field of clinical research.
JLI also provides focussed courses in the field of pharmacovigilance, medical writing, clinical data management, clinical quality assurance, regulatory affairs medico-marketing and pharmaceutical medicine.
For more information please visit: www.jli.edu.in