A CRA or Clinical Research Associate
monitors research studies and trials in a CRO (Contract Research Organization),
a pharmaceutical company or a biotech company. Their responsibility is to
ensure adherence to clinical research guidelines, FDA approved methodology and
SOPs (Standard Operating Procedures). Since the role of a CRA is that of utmost
responsibility, rigorous clinical
research training and certification from recognized organizations is an
essential requirement.
Clinical
Research Training and Certification
Organizations involved in
clinical trials look for candidates who are certified and have undergone
validated and standardized training. The work of a CRA is critical to the success of a clinical research project and therefore, a
great deal of importance is given to finding certified and well-trained
candidates. There are a few good clinical
research courses in Hyderabad that students can opt for. CRAs with prior
experience but without certification can opt for the valuable CRA Training and
Certification Program which would certify them as a CRS Certified Clinical
Research Associate. This certificate will be value addition to their work
experience and recognition in the industry. Certification is however not
necessary to start working as a clinical research associate. Students with a life
science background can undergo clinical
research training at any worthwhile institute and find employment. A
certification will only add to their credibility and help them enhance their
career prospects.
Eligibility for CRA Certification
To be employed in the
clinical research field, one needs to be from a life science background with
training in clinical research. However, if students wish to get certified from
an official authority, they will need to have a good training, educational
background and work experience. Those without a sciences background but with
Master of Health Care Administration or other similar health-care related
qualifications can also apply for the certification program and will also be
eligible for future employment.
Certification Details
The program is conducted
through a 40-hour online structured training course where registered members
are offered access to the CRS portal for learning and certification. Core clinical
research training is conducted covering areas such as drug development,
regulations, roles and responsibilities, documentation, ethics, safety
reporting, etc. The certification examination for CRA is of 2 hour duration.Members
are also required to use resources from websites such as the FDA, local and
international policies, best practices, guidelines, etc. available at the
learning and certification portal of CRO. The certification is to be maintained
every two years from the issue of original certification. Certified individuals
are required to complete 24 documented hours of activity for the maintenance of
the certification, which is to be achieved by accumulating credits through CRE
(Continuing Research and Education) and CPE (Continuing Professional
Engagement).
Other Certifications
Certification can also be
sought from organizations such as Association of Clinical Research
Professionals (ACRP) and Society of Clinical Research Associates (SoCRA). However,
even these certifications require prior clinical research experience. The
experience could be as a clinical research coordinator or any other role in a
clinic setting or in the pharmaceutical industry. Any role in clinical research
can be counted as experience as long as a manager or HR personnel will attest
to your experience.
Ikya Global is one of the
few best Clinical
Research training institutes in Hyderabad that offer training at affordable
prices along with placement assistance and certification.
For more Details Please
Visit our Website
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