All about clinical research

Clinical Research is an integrated branch of healthcare and science that comprises the study of safety, including the effectiveness of medications, devices, diagnostic products, and treatment for human use. Clinical Research limits the best way for the prevention and treatment of various diseases. There are numerous clinical research courses  available online and offline.

An individual who practices Clinical Researches and has studied clinical research courses is usually referred to as a Clinical Research Investigator. The field of Clinical Research is generally divided into three major parts, i.e.

  • Patient-Oriented Research
  • Epidemiologic and Behavioral Research
  • Health Service research.

The experiments are done with a test article subjected to pre-clinical studies or animal studies.

Areas of this field

Clinical researchers are responsible for ensuring these trials are conducted ethically while following good clinical practice and ensuring all team members are compliant with strict rules and regulations. They are required to handle documents and materials safely and securely diligently. Overall, the researchers are responsible for recruiting and screening patients, maintaining patient care in terms of health and progress, and then submitting the findings to the sponsoring organization upon completion. Clinical research institutes in Mumbai and Clinical research training in Bangalore provide various clinical research training to the students.

To work in the field, clinical researchers must have at least a master’s degree in science or medicine, with some positions requiring a Ph.D. and relevant specialist experience. Employers include hospitals, universities, pharmaceutical labs, and government departments. Essential skills are critical thinking, complex problem solving, and decision making, along with excellent numerical, written, and verbal communication skills.

Overall, the role of a clinical researcher involves writing drug trial methodologies, including designing trial materials, briefing the team of investigators with instructions on how to conduct the trials, setting up trial study centers, authenticating case report forms, and monitoring overall progress throughout the trial.

Opportunity by profession

Here, is the list of various job types which one can opt for choosing his career in Clinical Research Industry:

CRA (Clinical Research Associate):

The role of CRA in clinical research is like a soul in our body. One can give a kick-start his career as a CRA. The key responsibilities of a CRA can be divided into three steps:

  • He works as a healthcare professional who performs activities such as planning, execution, and supervision related to clinical trials.
  • He can also assist in creating manuscripts and presentations related to scientific meetings, technical journals, and training programs.
  • CRA has to conduct and monitor complex clinical trials and to ensure the quality of clinical practices.

Many organizations provide practical training in Clinical Research. Some organizations require certifications to practice as a CRA, depending upon their policies.

Biostatisticians:

A biostatistician has the critical responsibility to perform statistical and programming designing. One has to analyze the cause of issues affecting a living organism statistically. Preparing summaries and reports is another role of a biostatistician. He is also responsible for the submissions of Biological License Applications and New Drug Applications. Research is a significant role for a bio technician. One can moreover pursue his career in medical research in government agencies.

Post requirements: Bachelor’s degree is enough at the initial level to be a biostatistician. For advanced work, one should have a master’s or doctor’s degree in mathematics and biology as core subjects. 

CRM (Clinical Research Manager):

CRM is the managerial post in Clinical Research. One who has a strong science background and capability of doing work independently can apply for this post. The role of a CRM is to supervise the designing and writing of protocols, case report forms, and informed consent forms based on clinical trials. One has to do this work regularly and have to submit them to the management group on time. One should have the ability to organize all the paperwork systematically.

Post requirements: One should know how to enter data on electronic systems as well. One can get a job in various government and non-government organizations such as MHRA (Medicines and Healthcare products Regulatory Agency), WHO (World Health Organization), Pharmaceutical companies, and more.

CDM (Clinical Data Manager):

Candidates who have experience in IT, along with management, can apply for the post of Clinical Data Manager. One has to research critical aspects based on clinical trials. He has to collect data from various medical research projects, whether clinical or pharmaceutical. He should manage all the data clearly and securely and prepare reports, data charts, and other medical presentations for the management or research team. 

Post requirements: One should have the leadership, database, and communication skills, and ability to do teamwork and able to travel whenever required. Along with graduation in health informatics, a Master’s degree may be necessary for growth in this field. Some certificate courses are also offered online to get flexibility in this field.

Clinical Research Coordinator: 

CRC (Clinical Research Coordinator) is a specialized professional in clinical trials. He has to work under the supervision of CPI (Clinical Principal Investigator). CRC plays a critical role in supporting, facilitating, and coordinating all the clinical trials regularly. They are known as the organizers in the research lab. They have the responsibility to ensure the quality and safety of clinical trials. They have to provide accurate proof of medical advances, which are essential to take preventive care against various diseases. CRC is also responsible for setting a budget for research and coordinating with multiple companies for funding either through private or grants for the project. He has the responsibility to meet all the terms and conditions regarding safety, government policies, and ethics of medical organizations.

Post requirements: The ability to thoroughly analyze all the aspects of a budget is the crucial requirement for the post of CRC. One should have communication and organization skills to take new projects or hire a research team. One can apply for this job after completion of a Bachelor’s degree in science subjects such as chemistry, biology, physiology, anatomy, pharmacology, biomedical ethics, and clinical research management. One can also enter into this field after completing a vocational course and clear the clinical research professional exam for getting the professional certificate in clinical research.

Regulatory Affairs Manager (RAM):

The role of the Regulatory Affair Manager is to bridge the gap between pharmaceutical companies and government agencies. He has the crucial responsibility to ensure the company’s legal compliances, to track the legislation process, to register documents for filing. One has to research if there is any change in government norms. He has to analyze new laws and ensure how they fit into the company by changing company policies.

Post requirements: One should have at least seven years of practical experience, along with a Bachelor’s degree related to this field. One should know various legal aspects, practices, and procedures. One should have to perform multitasking by working in a single company or multiple regulatory agencies.

Pharmacovigilance Associate (PVA):

Pharmacovigilance is connected to the safety of drugs. It plays a vital role in accessing all the risks and benefits of pharmaceutical products. The purpose of the PVA is to ensure the safe use of the drug in patients of all age groups. One has to perform on initial stages of safety notifications related to any medicine; plan, execute, and carry out Individual Case Safety Reports (ICSRs). You can also follow your career as a Pharmacovigilance Manager, Senior Drug Safety Officer, and director of any pharmacovigilance company.

One should have a Bachelor’s degree in Life sciences such as the faculty of medicine, pharmacy, biochemistry, or veterinary. One who has equivalent nursing and medical requirement can also enter into this field. Excellent communication and IT skills, multitasking, teamwork are required for this post. One who has fluency in a foreign language and had practical communication skills may also get an opportunity to work on an international level.

Other Job Types:

Clinical Research is a vast field related to medical or healthcare science. Due to the establishment of various national and international companies, there is a rise in demand for qualified professionals in this field. One can opt for different other job types such as CRO (Clinical Research Organisation), Clinical Research Investigator (CRI), Research Nurse, Research site manager, Counsellors, Research Auditors, Project Manager, Marketing Executives, Contract Managers, Quality Assurance specialists (QA), Business Development Manager (BDM), Translators, Lab staff and more. One can get a pay scale as per his job profile, experience, and specializations related to the clinical research Industry.

Better scope by ICBio in clinical research

Clinical research is a growing business in India. Earlier days, we did not have much exposure to these fields of research. But now India has produced more than 1000 GCP trained investigators and 5000 trained CR professionals, who are successfully handling several global multicentric studies. Clinical research also has outstanding career prospects, flourishing market, knowledge-intensive job, national & international cross-cultural exposure, quick money, consistent growth. A large number of multinational companies are setting up research facilities due to cost benefits and substantial workforce available in India. Remarkably, Clinical Research Courses are the courses that cover broader aspects of clinical trials, and interestingly it is also a career option with massive growth potential. A PG diploma in clinical research is also available for students. An MSc in clinical researchas well as a  a Diploma in clinical researchcan be done by students.