A clinical research associate aka CRA, is also called a trial monitor or clinical monitor, is a health professional that performs many type of activities which are related to medical research, specifically clinical trials. A clinical research associate will work in various types of settings, such as pharmaceutical companies, medical research institutes and government agencies. Depending on the type of jurisdiction clinical research associate is in, different education and certification requirements may be required to practice as a proper clinical research associate.
The main tasks of a clinical research associate aka CRA is always defined by good clinical practice guidelines for monitoring all sorts of clinical trials, such as those exclusively mentioned by the International Conference on Harmonization of Technical Requirements for registration of Pharmaceuticals for Human Use (ICH).
What is a Clinical Research Associate’s Job?
Monitoring clinical trials is the main function of a clinical research associate. The clinical monitor has an option to work directly with the sponsor company of a clinical trial, as an independent freelancer or for some contract research organization aka CRO. A clinical monitor makes sure that everything is done in compliance with the clinical trial protocol, checks all clinical site activities, makes onsite visits, reviews all types of case report forms aka CRF, and coordinates with clinical research coordinators. Clinical research associates or clinical monitor also assures the protection of all the rights, safety and well being of human study subjects. In addition to this, a clinical research associate must make certain that the scientific integrity of the entire data which is collected is protected and completely verified and also assure that all adverse situations are correctly documented and reported.]
A clinical monitor should usually require possessing an academic degree in Life Sciences and should have a good knowledge of good clinical practice and all of the local regulations.
What certifications and practice method a Clinical Research Associate needs in different countries?
The Canadian Association of Clinical Research Specialists which is also CACRS is a federally registered professional association in Canada with a Registration Number: #779602-1. The CACRS is a not-for-profit organisation which promotes and manages situations on behalf of its members in the field of Clinical Trials & Research. The Canadian Association of Clinical Research Specialists has a comprehensive certification program which includes the Clinical Research Specialist also know as CRS designation, which is a professional title attained by passing an extremely high level exam. Applicants who have a doctorate degree in science or medicine are required to have a minimum of two years of prior experience whereas a bachelor ’s degree holder is required to have a three years of prior experience before taking the qualifying exam.
In the European Union, the practice guidelines for Clinical Research Associates are a part of EudrLex.
In India, Clinical Research Associates requires to have a knowledge about schedule Y amendments in drug and cosmetic act 1945.
In the United States, the rules that are required for a good clinical practice are codified in Title 21 of the Code of Federal Regulations. CNN Money has listed Clinical Research Associate at No.4 on their list of the best jobs that you should do in America in the year 2012, with an average salary of $90,700.
The Society of Clinical Research Associates also known as SOCRA is a non-profit organization which is dedicated to the continuing development & education of clinical research enthusiasts. The Society of Clinical Research Associates has introduced an International Certification Program in order to develop an internationally accepted standard of education, knowledge and experience by which Clinical Research Associates will be recognized as Certified Clinical Research Professionals also known as CCRP in the current clinical research community. The average standards upon which this certification program is made on has been developed by this organisation to only promote recognition and developing excellence in the ethical way of conduct of clinical trials. Society of Clinical Research Associates provides training, education, and a great certification program. A Clinical Research Associate who is certified through Society of Clinical Research Associate’s certification program receives the designation and a role of a Certified Clinical Research Professional.
The Association of Clinical Research Professionals which is also called ACRP provides a certification for Clinical Research Associates, specific to their job function performed. The Association of Clinical Research Professionals offers the designation and role of a Certified Clinical Research Associate which is also known as CCRA. In order to become accredited as a Certified Clinical Research Associate, the Clinical Research Associate has to pass a CCRA examination other than meeting other specific requirements. Before applying for the exam, the aspirant must show that they have worked independently of the investigative staff conducting the research at the site or institution, in order to make sure that the person doesn’t get an opportunity to alter any data. The applicant should also show that they have worked a minimum number of hours mentioned in accordance with study protocols and Good Clinical Practices, including ensuring that all adverse drug reactions are immediately reported and all necessary documentation is properly completed.
If you are looking to have a career in clinical trials then we recommend you should have this role of clinical research associate in mind. If you get an opportunity in the USA then trust us your pay scale will only be above the sky.
For more details on this topic get click here now.
Tag:clinical data management, clinical research associate, clinical research associate training, clinical research coordinator, clinical trial application, clinical trial protocol, clinical trial regulation, clinical trial research, clinical trials training, phases of clinical trials, worldwide clinical trials