Clinical research is an attractive industry which foresees tremendous
growth and job opportunities not only for trained medical, pharmaceutical
and paramedical professionals, but also for regulatory authorities, government
and the society at large. With the inflow of multinational players in
research, the industry is poised to grow exponentially and open up new
vistas of employment for a large number of people.
Candidates can make their career in the fields of
Contract Research Organizations (CRO)
Pharmaceutical Industries
Biotechnology Companies
Medical Device Compamy
Patient Recruitment Organisations (PRO)
Clinical Data Management
Regulatory Affairs
Pharmacovigilance
Medical Writing
Central Lab
Logistics and Courier Services
Research Sites
Auditing of Clinical Trials
Basically Clinical Research is conducted by the Pharmaceuticals, Biotech
and Medical Device companies. They outsource their work to Contract Research
Organizations (CRO Company). The CRO perform the clinical trial on behalf
of the company in collaboration with the Site / Hospital or SMO (Site
Management Organization). Before conducting clinical trials, approval
is required from regulatory authorities of that country where the trial
has to be conducted. This approval process is done by the Regulatory Affair
Company or by CRO itself if they have their own Regulatory Affair department.
Data is generated during clinical trial in the form of CRF (Case Report
Form) which is designed and managed by the Clinical Data Management Company.
Sample collected during the trial is sent to the Central lab through a
logistics and courier services company and is analysed and reported by
the Central Lab. After completing the trial, publication is done with
the help of Medical writing company.
Every clinical study is led by a principal investigator. These investigators
can be researchers, professors, medical practitioners and scientists/
medical specialists. Besides them, clinical studies may also have a research
team that may include nurses, social workers and other health care professionals.
Varied options are available in the field of Clinical Research Organisations.
Clinical Research Associate, Clinical Research Investigator, Clinical
Research Managers, Clinical Research Coordinator, Clinical Data Manager,
Clinical Research Auditor, Biostatisticians, Pharmocovigilance Manager,
Quality assurance etc.are some of the designations in the field of clinical
research. Their work areas include :
Clinical Research Associate : The most common entry-level position
in the field of clinical research is that of a Clinical Research Associate
(CRA). Clinical Research Associate has the responsibility to design,
implement and monitor clinical trials. The administration and progress
of a clinical trial is examined or monitored by him /her. They assist
in preparation of presentations and manuscripts of scientific meetings
and technical journals, and attend scientific/ professional meetings
and training courses.
Clinical Research Managers (CRM) : Clinical Research Managers
have the responsibility to supervise the design and writing of protocols,
case report forms and informed consent forms for clinical trials. It
is the CRM's who ensure that case report forms are evaluated within
a reasonable time and submitted to the data management group.
Biostatisticians : Biostatisticians are responsible for New
Drug Applications and Biological License Application submissions. Their
duties involve planning, coordinating and providing statistical analyses,
summaries and reports of studies for clinical trial projects.
Clinical Research Investigator/ Physician : Clinical Investigator
will be generally a physician possessing a license to practice anywhere
in the country. They are responsible for recruitment and treatment of
patients.
Clinical Research Coordinator : Clinical Research Coordinator
has to co-ordinate the clinical trials using good clinical practice under
the direction of the Chief Investigator.
Pharmacovigilance Manager : They ensure that the individual
reports are accurate and perform other related duties as assigned or
requested by the Senior Director.
Quality Assurance (QA) : Quality assurance department supremely
deals with validation of all aspects of the clinical trial process which
includes proper vigilance of safety, efficacy, purity, and stability
of end products.
Project Manager and Marketing Executives : It is the duty of
these professionals to make sure that a particular drug is not only
safe and effective but is also cost-effective for efficient disease
management.
Account Directors: This includes a number of other designations
like Business Development Analyst, Clinical Project Director, and Clinical Program
Manager. A degree in Life Sciences and interest in medical writing and
pharmaceutical marketing is a must.
Clinical Auditors: This includes GCP specialist and QA auditors.
A graduate level qualification in Life Sciences with a strong knowledge
about GCP, GMP, GLP auditing processes is the requirement.
Contract Managers: This includes Contract Associates, Senior
Proposal and Contract Managers, and Senior Project Managers. One must
possess a bachelor's degree in life sciences with work experience in
proposal writing and thorough understanding of complete clinical development
process.
Drug Safety Scientist: This includes Drug Safety Monitor, Drug
Safety Officer, Drug Safety Associate. A masters degree in Life Sciences/Pharmacology
with good experience in medical writing, computers, regulatory requirements,
drug information and other clinical processes.
Regulatory Affairs Manager: This includes Senior Regulatory
Associates, Manager (Regulatory Affairs) etc. A graduate degree in Life
Sciences, Clinical research experience and knowledge of FDA requirement
is a must.
Career opportunities in clinical research is based on the academic qualification
of the individuals.
• Doctors - Doctors
are appointed in Clinical trials as Principal Investigator, Co-Investigator,
Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical
Research Physician. • Pharmacists, Life Science graduates,
Science postgraduates in Biochemistry - They are appointed as Site
Coordinators, Clinical Research Associate, Medical writers, Clinical Research
Manager and Drug Development Associate, Biostatistician, Quality assurance • Management Graduates (MBA) -
MBA graduates can choose the areas of Business Development, Clinical Project
Management, Clinical Research Management, Regulatory Affair Management.
• IT professionals, Biostatistician,
Engineers, postgraduates in Maths, Applied Maths, operational Research,
Statistics - These professionals can find opening as Clinical Data
Manager, Drug Development Associate
There are various growth opportunities along the way for those who are
willing to learn. For those interested in serious research work, a PhD
is the ideal solution. There are post graduate degrees and diplomas offered
by various colleges which come in handy to enhance one's career prospects.
Specialization in branches of pharmacy, life sciences, biochemistry will
be useful. Studying further will also help one in bettering their current
job profile. For instance doing masters will enhance the job prospects
of a CRA to become a Project Manager. Similarly a PhD in a related discipline
is needed to become a Medical Director.
