The clinical research associates (CRA), often known as a clinical monitor or trial monitor, is a health-care practitioner that helps with medical research, including clinical trials. Clinical research associates operate in a variety of contexts, including pharmaceutical firms, medical research institutions, and government bodies. Different education and certification requirements may be required to practise as a clinical research associate depending on the jurisdiction. The CRA’s primary responsibilities are outlined by good clinical practise recommendations for clinical trial monitoring, such as those developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. A CRA could eventually advance to the positions of Feasibility Leader, Study Start-up Leader, Project Manager, and Project Director in a pharmaceutical firm or contract research organisation. A CRA is often expected to have an academic degree in Life Sciences and to be well-versed in appropriate clinical practise and local legislation.
Overview
A clinical research associate’s primary responsibility is to monitor clinical studies. The CRA may work directly with the clinical trial’s sponsoring firm, as an independent freelancer, or for a contract research organisation (CRO). A clinical research associate supervises protocol adherence, monitors clinical site activity, conducts on-site visits, examines case report forms (CRFs), and interacts with clinical research coordinators. Clinical research associates also “ensure the protection of the rights, safety, and well-being of human study subjects.” A CRA must also “ensure that the scientific integrity of the data collected is protected and verified,” as well as “ensure that adverse events are properly documented and reported.”
Certification and application
Canada
The Canadian organisation of Clinical Research Specialists (CACRS) is a professional organisation that is federally recognised in Canada (Reg. #779602-1). The CACRS is a non-profit organisation that promotes and advocates for its members in clinical research and clinical trials. The CACRS provides a thorough accreditation programme, which includes the Clinical Research Specialist (CRS) credential, a professional title earned by completing a qualifying test. previous to taking the qualifying test, applicants with a doctoral degree in medicine or science must have two years of previous experience, while those with a bachelor’s degree must have three years of prior experience.
The European Union
The practise guidelines for CRAs are part of EudraLex in the European Union.
India
A CRA in India must be familiar with the New Drugs and Clinical Trials Rules, 2019.
The United States
The norms of good clinical practise in the United States are codified in Title 21 of the Code of Federal Regulations. Clinical Research Associate was ranked #4 on CNNMoney’s list of the “Best Jobs in America” in 2012, with a median income of $90,700.
SOCRA is a non-profit organisation that is “dedicated to the continuing education and development of clinical research professionals.” The Society of Clinical Research Associates (SOCRA) has created an International Certification Programme to establish an internationally recognised standard of knowledge, education, and experience by which CRPs will be recognised as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. This organisation established the principles on which this certification programme is based in order to encourage recognition and ongoing excellence in the ethical conduct of clinical trials. SOCRA offers training, ongoing education, and certification. A accredited Clinical Research Professional (CCRP®) is a CRA who has been accredited by SOCRA’s certification programme.
The Association of Clinical Research Professionals (ACRP) certifies CRAs based on the job function performed. The ACRP provides the Certified Clinical Research Associate (CCRA®) accreditation. To become a CCRA®, the Clinical Research Associate must pass a CCRA® test as well as satisfy additional particular criteria. Before completing the test, the prospective candidate must demonstrate that they “work independently of the investigative staff conducting the research at the site or institution,” in order to assure that no data will be altered. The candidate must also demonstrate that they have worked the appropriate amount of hours in line with research protocols and Good Clinical Practises, including reporting adverse drug reactions and completing all essential paperwork. The number of hours required to complete these activities is determined by the level of education attained; for example, someone who has only graduated from high school must complete 6,000 hours, whereas a registered nurse, person with a bachelor’s, master’s, or doctorate of medicine degree must complete only 3,000 hours. The ACRP’s CRA certification programme is approved by the National Commission for Certifying Agencies (NCCA), the Institute for Credentialing Excellence’s certifying authority.
