Thursday, November 21, 2019

Job opportunities after completing Clinical Research Course



Introduction to Clinical Research


It is a well-known fact that for overall career growth; right education, acquiring practical knowledge and developing a right attitude is of immense importance especially in specialized industries such as clinical research. Clinical research defines the entire profile of a drug or any newly fabricated medical devices, tracking its development right from its inception in the research centre to the consumer market and beyond. The recorded history of clinical trials goes back to the biblical descriptions in 500 BC.[1] The drug development and medical device industry has observed a remarkable evolution over the decades. Due to a paradigm shifting change in the field of biotechnology and pharmaceuticals, companies have gained momentum in developing highly unique and safe medical devices and drug molecules.


What happens in Clinical Research


The new molecule or device is subjected to pre-clinical and clinical trials before entering the market, which is later followed by post-marketing surveillance. Pre-clinical studies consist of studying and analysing the effects and side-effects the drug has on animals, that generally comprises of carcinogenicity, teratogenicity and toxicological studies. The successful pre-clinical studies call for an Investigational drug application (INDA) to take permission for human studies, to mark it eligible to conduct clinical trials (four phases) in human population.[2]

Types of Clinical Research


Based on study design, there are two main types of clinical trials, Observational and
Interventional study:

The U.S. Food and Drug Administration (FDA) and its corollary agencies abroad have classified four phases that needs to be administered during a clinical trial: [2]

Phase I trials:
  • Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
  • Length of Study: Several months
Phase II trials:
Phase III trials:
Phase IV trials: 
Market value of Clinical research

In the year 2017, the market size of Indian clinical trials was valued to be around USD 1.6 billion. It is likely to develop with a growth rate of 8.7% by the year 2025. India has been ranked second (after China) in terms of patient population for clinical trials. To add on, the low cost of clinical trials in India in comparison to United States of America and Europe is an important aspect to drive the market growth. [3]

Importance of Clinical Research

Clinical trials not only provide the masses with information about an upcoming blockbuster drug but can also shed valuable information on the benefits and safety of existing therapies, providing reliable information for doctors and patients to choose between alternative therapies.

Finally, since "to ensure their safety and efficacy, any drug or medical device must be thoroughly examined through closely monitored and highly regulated clinical trials," patients receiving medical attention should be encouraged to participate in clinical trials.

Clinical trials benefit the scientist the most, since it makes clear whether or not a drug will ever be suitable for human applications. Clinical trials also help doctors decide whether, when weighed against the potential benefits, the side effects of a new treatment are acceptable.

Only in the rarest of cases does a patient get affected by a drug or during a clinical trial procedure. Yet it is praiseworthy to note that millions of people are benefited because other people before them chose to participate in a study that resulted in a new, more effective treatment.

Why a career in Clinical Research?

The entire process (as mentioned above) is aided by pharmaceutical firms and a large number of expanding clinical trial management organizations including contract research organizations (CROs), site management organizations (SMOs), clinical data management, knowledge process outsourcing (KPOs), investigator and site staff, etc. These organizations demand competent and skilled work force in the clinical research industry.

The major clinical research companies in the area are Biocon, GlaxoSmithKline, Johnson & Johnson, Astra Zeneca, Ranbaxy Laboratories, Nicholas Piramal, Pfizer etc.

In the field of CROs, the key players are Quintiles, ICON International, Inc., Clintec, Accenture, Parexel etc.

Job roles in CROs / Pharma / Biotech Companies [4]
  •  Clinical Trial Assistant (CTA)
  •  Clinical Research Associate (CRA)
  •  Senior CRA
  •  Clinical Team Leader
  • Project Manager
  • Senior Project Manager
  • Manager Medical & Regulatory
  • Manager –Safety / Patents
  • Manager Quality Assurance 
  • Medical Director
  •  Associate Director –Clinical 
  • Associate Director –Projects
  •  Director –Business Development 
  • Director / Head (Clinical Operations)
  •  General Manger / CEO / President
Job roles in SMOs [4]
  •  Clinical Research Coordinators (CRC) / Study Coordinators
  •  Principal Investigators / Co-Investigators
  •  Medical Monitors
  •  Project Manager / Senior Project Manager
  •  Manager Medical & Regulatory
  • Manager Quality Assurance
  • Manager –Business Development
  •  Medical Director
  • Associate Director –Clinical
  • Associate Director –Projects
  •  Director / Head (Clinical Operations)
  •  General Manager / CEO / President

Job roles in DM [4]
  •  Data Entry Operator
  •  Data Validation Executive
  •  QA Executive
  • Data Manager
  •  QA Manager
  •  Statistical Programmer
  •  Statistician
  •  Data Reviewer
  • Data Base Designer
  • Medical Writer
  • Head –Data Management
Courses in Clinical Research

A course in clinical research, followed by a basic graduation or post-graduation in the field of medical science, life science, dental science, pharmacy and pharmacological science, can definitely open up many opportunities to create a career in the industry. A typical course in clinical research includes information about basic pharmacology and pharmacy in clinical research, guidelines and regulations in clinical trials, ethics in clinical research, biostats & clinical trials design, clinical trial documents, clinical trial management, drug safety & pharmacovigilance etc. A specialized course will generate well trained, experienced and resourceful professionals with formal trainings in research methodology, good clinical practice (GCP), regulatory affairs, documentation and conducting impeccable clinical trials.

Turacoz Skill Development Program offers you with a six-month diploma course in Clinical Research and Scientific Writing. The course gives an in-depth knowledge about clinical research and different types of scientific documents including publication and medico-marketing documents.

Learning Objectives:

After taking this course, you should be able to understand the –
  • Basics of clinical research, drug discovery and development.
  • Protocol, informed consent form, clinical summary report.
  • Ethics in clinical research and publications.
  • Scientific publications and role of medical writers in scientific publication.
  • Lifecycle of a manuscript - Planning, writing, reviews and finalization and submission.
  • Importance of conferences and documents involved in conference support – abstract, poster and oral presentation Types of medico-marketing documents and different deliverables.
Have a look at the courses we offer, by clicking here.

Contact Dr Smriti Khatri, Manager of Business Development and Training at Turacoz Healthcare Solutions for any further information or quires.

References:


Author: Madhu Kumari




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