Careerin Clinicl research

Careers in Clinical Research

Introduction
Clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use.
A Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.
Nature of Work
To begin with the individual works for the Investigator or a University/Academic institution. He/She handles most of the administrative responsibilities of a clinical trial, is the liaison between the clinical trial investigative site and the sponsor of the clinical trial, and reviews all data and records before a CRAs (Clinical Research Associate) visit. The title can be research nurse, trial coordinator, study coordinator, research coordinator, or clinical coordinator. Ideally speaking Clinical Research branches off into various categories at the entry level.
The most common entry-level position is that of a Clinical Research Associate (CRA). The role of a CRA is varied:
They are key participants in the design, implementation and monitoring of clinical trials
They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.
They assist in preparation of presentations, manuscripts of scientific meetings and technical journals. They attend scientific/professional meetings and training courses as appropriate.
A clinical researcher studies issues and concerns related to mental health and wellness. Clinical researchers have a wide array of goals: understanding the etiology of disease and the disease process, identifying and evaluating potential treatments and their outcomes, and studying policies related to the delivery of services.
Personality
This is a combination of Medical practice, Surgery and alike on one hand and Pharmacy & Research on the other. So the candidate should be mentally prepared to put in long working hours with compassion and humane attitude.
Prerequisites
B. Sc. degree is a must to enter this field. Ideally the industry is looking for science graduates from pharmacy, medicine, life science and bioscience. Within bioscience too there are various other fields such as botany, zoology, biochemistry and genetics. Anybody who fulfils these criteria can join the industry.
Those with Nursing Degrees and or Nursing experience, Life Science degrees, Clinical Research Coordinators, Laboratory Technicians, Clinical Research Associates, Medical Research Associates, Clinical Scientists, members of an Institutional Review Board, Investigators, Investigator clinical trial site staff, Study Coordinators and Pharmacists can benefit from this course as the online training program gives an overview of conducting clinical trials, drug development process, and human safety protection.
No age is a barrier for pursuing Clinical Research, but surely, the age range allowed to pursue training in Clinical Research depends on a number of factors, with safety always first in mind.
Professional Courses
Almost all Institutes imparting training in Clinical Research conduct courses like Diploma and Post Graduation. The PhD facility is in selected few.
The CRCDM 6 month weekend course at Pune University is useful for:
Doctors - Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician.
Pharmacists, Life Science graduates, Science postgraduates in Biochemistry - Medical writers, Clinical Research Associate, Site Coordinator, Clinical Research Manager and Drug Development Associate, Biostatistician,Quality assurance
Management Graduates (MBA) - Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management.
IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics - Clinical Data Manager, Drug Development Associate
After completion of this course Participants should be able to:
Have better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management.
Contribute more effectively in their profession pharmaceutical/ biopharmaceutical companies in drug development, CROs offering clinical research and clinical data management services, in bio-IT life science industry, or academic research institution or as clinical investigators at hospitals/ medical sites conducting trials on subjects.
Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC) system and Project Monitoring.
Participate in design, conduct and management of global clinical trials conducted at multicentric sites in India and Overseas.
Have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct of different therapeutic trials for preparing the submissions made to the regulatory authorities for seeking market authorization in India, US, EU, Japan etc
Selection of Institute and courses
It is an individual's call to select the course depending on socio-economic factors and personal vision. There are a number of Institutes in India. The right choice would be the one backed by Pharmaceutical Organizations for Clinical trails, Sponsorships in various forms, funds to support in long term commitment.