In today’s world, where people are being diagnosed with new diseases on a regular basis, medical innovation from clinical research studies has become a necessity. A clinical research expert is required to develop the best treatment for each condition. Clinical researchers are looked upon to conduct clinical trial/vaccine trial on various medicines before they can be sold on the shelves of a pharmacy or delivered to people’s homes. Every year, approximately two lakh individuals are employed in the clinical research. The clinical research business is worth over $26 billion every year. Clinical research graduates or clinical research msc have great career prospects in India as well as international locations like Singapore and the United States, where they can earn good money.

In order to complete a proper clinical trial, clinical research requires the collaboration of professionals from different fields. Clinical research offers a variety of professional opportunities, ranging from administrative to technical professions. The person interested in pursuing a career in clinical research can pursue clinical research courses online or offline from clinical research institutes in India.

Depending on their area of interest, one can apply in the following fields:

  1. Clinical Research Coordinator (CRC)

A CRC works with the Principle Investigator. He facilitates and coordinates the clinical trials with assurance of good clinical practices. He is responsible for day-to-day clinical research studies at places like universities, medical schools, hospitals, independent medical practices and any research company or institutes. The personnel are required to provide precise proof regarding the medical advances which are necessary for preventive care for different diseases.  He is responsible for treatment or direct care of the patients in the clinical trial, recruitment of subjects for the vaccine trial and setting the budget for the clinical trial thereafter coordinating with companies for funding.  Additionally, a CRC is required to monitor that the research is carried out in accordance with the policies (terms of ethics and safety) of sponsors and regulatory authorities. CRC personnel with efficient clinical research education along with experience on vaccine trials are able to promote to Clinical Research Associates role.

2.Clinical Research Associates (CRA)

CRA is also known as the monitor who is employed by the contract research organizations (CRO) and pharmaceutical organizations. The clinical research associates work as a role of healthcare professional and participates in major activities of designing, planning, implementation and execution and involved in monitoring clinical research studies ensuring proper regulations of the ethical standards, operations and standard regulatory procedures as per SOP and GCP are being followed. They have to travel between the institutes conducting virtual visits or physical monitoring to ensure that each trial centre has adequate trial materials including the investigational medicinal drug or trial drug..

3.  Medical Writer

Documentation accounts to be the most important component of any clinical research study. Medical writers work with clinical research scientists, doctors and subject matter experts for describing clinical research results, products in use, and the related medical information for publishing.  The personnel are employed by organizations conducting clinical trials/vaccine trials, government agencies, pharmaceutical companies, hospitals and even by marketing companies.

4.  Clinical Research Manager (CRM)

A CRM is a clinical trial manager that supervises the design and development of protocols, case report forms, and informed consent forms. He’s also in charge of making sure the case report forms related to clinical research study are evaluated and sent to the data management department on time. CRMs can work for a variety of government and non-government organizations, including the World Health Organization, pharmaceutical corporations, and the Medicines and Healthcare Products Regulatory Agency (MHRA).

5. Clinical Data Manager (CDM)

A CDM’s job is to gather information from a variety of clinical research projects and provide critical analysis based on clinical trials. He should also be able to effectively organize the data and generate reports, data charts, and other medical presentations for management or the clinical research team.

6.  Regulatory Affairs Manager (RAM)

A RAM’s responsibilities include bridging the gap between pharmaceutical organizations and government bodies conducting vaccine trial, as well as ensuring legal compliance, tracking legislation procedures, and registering documents for filing. Any new laws or changes in government norms must be reviewed and assessed by him in order for him to assist in the modification of company policies to comply with the laws and standards.

7. Bio-Statisticians

This job role requires performing statistical analysis and programming designing related to the clinical trial. The biostatistician prepares summaries, statistical input and reports according to his research and therefore interprets the final data for clinical trial. The person is also responsible for submitting the New Drug and Biological License Applications.

8.  Quality Assurance Auditor

These professionals examine the clinical trial materials and processes to ensure that they follow the ICH GCP, New Clinical Trial rules and regulations 2019, SOPs and Approved protocol.

9.  Pharmacovigilance Associates

They serve a critical role in gathering all available information about the risks and benefits of pharmaceutical goods, ensuring that patients of all ages receive safe drug.

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