Clinical research associate
||This article may be too technical for most readers to understand. (January 2013)|
A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). While ICH GCP uses the term "Monitor" instead of CRA, the two terms are considered to be synonymous.
The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. Clinical research associates also "assure the protection of the rights, safety and well being of human study subjects." Additionally, a clinical research associate must "make certain that the scientific integrity of the data collected is protected and verified" and "assure that adverse events are correctly documented and reported." A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical practice and local regulations. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union, these guidelines are part of EudraLex. In India, a CRA requires knowledge about schedule Y amendments in drug and cosmetic act 1945.
Clinical research associate certification
The Canadian Association of Clinical Research Specialists (CAOCRS) www.caocrs.org is a federally registered professional association in Canada Reg. #: 779602-1, see the Government of Canada Profile. CAOCRS is a not-for-profit organization that promotes and advocates on behalf of its members in the field of Clinical Research and Clinical Trials. CAOCRS has a comprehensive accreditation program including Registered Clinical Research Associate (RCRA) designation, this is not just a certification, but rather a designated professional title conferred upon qualified applicants and members by passing a qualifying exam under the Charter and the seal of the Association and is recognized globally. Clinical Research Associates field of practice is growing rapidly and is becoming more regulatory driven, hence it's critical to be regulated by recognized and registered professional agencies such as CAOCRS.
The Association of Clinical Research Professionals (ACRP) provides a certification, specific to the job function one actually performs, for CRAs. ACRP offers the accredited* CRA designation in the field, the Certified Clinical Research Associate (CCRA®). In order to become accredited as a CCRA®, the clinical research associate must pass a CCRA® examination in addition to meeting other specific requirements. Before taking the exam, the potential applicant must show that they "work independently of the investigative staff conducting the research at the site or institution." The purpose of this requirement is to ensure that the person will not have the opportunity to alter any data. The applicant must also show that they have a work for a sponsor and have a valid contract. The third requirement in order for a person to take the exam is to "perform essential CCRA® duties" for a required number of hours. These essential duties include ensuring that the study is being performed in accordance with the study's protocol and Good Clinical Practices, making sure that that adverse drug reactions are reported, ensuring that all necessary documentation is done, and performing "routine monitoring". The number of hours that must be completed performing these activities ranges from 3,000 to 6,000 hours and is based on the level of education the application has received. For example, someone who has only graduated from high school must perform 6,000 hours, but a registered nurse or person with a Bachelor's degree must only perform 3,000 hours.
- ACRP's CRC and CRA Certification Programs are accredited by the National Commission for Certifying Agencies (NCCA), the accrediting body of the Institute for Credentialing Excellence. For more information on accreditation, visit www.credentialingexcellence.org/ncca.
The Society of Clinical Research Associates (SoCRA) is a non-profit organization that is "dedicated to the continuing education and development of clinical research professionals. The mission of SoCRA is "to provide training, continuing education, and an internationally recognized certification program that promote quality clinical research to protect the welfare of research participants and improve global health." A clinical research associate who is certified through SoCRA's certification program receives the designation of a Certified Clinical Research Professional (CCRP®).
CNNMoney/PayScale.com listed clinical research associate at #4 on their list of the Best Jobs in America in 2012. The median salary was listed as $90,700.
- Clinical Research Training Online, Inc. http://www.clinicalresearchtrainingonline.com/signon/index.cfm?WA_ID=22