Introduction:
Pharmaceutical companies have
realized that they need to carry out an extensive range of clinical trials to
ensure the effectiveness of all novel drugs and devices and the safety of the
same so that they can be used by the general public. When such a scenario has
taken place, there would be creation of new job profiles and opportunities in
the clinical research sector. Apart from complying to strict regulatory measures,
India is developing as a growing center for clinical research which leads to
the demand for high and qualified clinical research practitioners in the
clinical research sector.
Demand for skilled professionals in
clinical research sector:
The demand for highly qualified
professionals has made it refutable that the clinical research industry would
be the choice of career among individuals in India. The country’s three major
advantages namely the huge population, significant resource and low cost
benefits have led to major pharmaceutical companies and clinical research
organizations establishing clinical research facilities in India. In order to
cater to the high demand for efficient clinical research professionals, many
institutes have designed various clinical research training courses. The
institutes play an important role in offering the required guidance and support
for the professionals to advance in their career. To support the carrier of
clinical research, many institutes has their modified more skilled clinical
research courses to teach, to guide, to make candidate best at genre
Given below are the top job
profiles that one can find in the clinical research sector:
CRA (Clinical Research
Associate):
The role of CRA in clinical
research is one who performs activities such as planning, execution, and
supervision related to clinical trials. The person also makes his or her contribution
in creating manuscripts and presentations related to scientific meetings,
technical journals, and training programs. In addition to these responsibilities,
the CRA has to conduct and monitor complex clinical trials and to ensure the
quality of clinical practices. Since, some organizations require certifications
to practice as a CRA, many institutes provide training courses in Clinical
Research.
The Clinical Research manager job
profile is that of a managerial role in the clinical research sector. A person who
has a strong science background and has the capability of doing work independently
is eligible for this post. The role of a
CRM is to supervise designing and writing of protocols, case report forms and
informed consent forms based on clinical trials. The professional should be
able to organize all the paperwork systematically and submit the completed work
on time to the management.
Clinical Research Coordinator:
Clinical Research Coordinator is a specialized
professional in clinical trials. The individual has to work under the
supervision of CPI (Clinical
Principal Investigator). This professional plays a critical role in supporting,
facilitating and coordinating all the clinical trials on regular basis as well
as ensuring the quality and safety of clinical trials. The Clinical Research Coordinator is also
responsible for setting a budget for research and coordinating with various
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.
Regulatory Affairs Manager (RAM):
The key responsibility of the Regulatory
Affairs Manager is to ensure company's legal compliances, to track legislation
process, to register documents for filing. Apart from that, the individual has
to carry out research to see if there is any change in government norms. Furthermore, the RAM has to analyze new laws
and ensure how they fit into the company by changing company policies.
Pharmacovigilance Associate (PVA):
The role of Pharmacovigilance
Associate (PVA) is to ensure the safety of a particular drug in patients of all
age groups. One has to implement initial stages of safety notifications related
to any medicine; plan, execute and carry out Individual Case Safety Reports
(ICSRs). After working as a Pharmacovigilance associate, one can advance in his
or her career as a Pharmacovigilance Manager, Senior Drug Safety Officer, and
director of any Pharmacovigilance company.
Apart from these
top job profiles, there is high demand for trained professionals in the
clinical research field due to the
establishment of various national and international companies, One can choose
job profiles such as CRO (Clinical Research Organization), Clinical Research
Investigator (CRI), Research Nurse, Research site manager, Counselors, Research
Auditors, Project Manager, Marketing Executives, Contract Managers, Quality
Assurance specialists (QA) and Business Development Manager (BDM),
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