A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care

profession A profession is a field of work that has been successfully ''professionalized''. It can be defined as a disciplined group of individuals, '' professionals'', who adhere to ethical standards and who hold themselves out as, and are accepted by ...

al who performs many activities related to

medical research Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientif ...

, particularly

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies. Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate. The main tasks of the CRA are defined by

good clinical practice Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...

guidelines for monitoring clinical trials, such as those elaborated by the

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pha ...

. A CRA would subsequently grow into a Feasibility Leader, Study Start up Leader, Project Manager, and Project Director at a Pharmaceutical company or a

contract research organization In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provid ...

. A CRA is usually required to possess an

academic degree An academic degree is a qualification awarded to students upon successful completion of a course of study in higher education, usually at a college or university. These institutions commonly offer degrees at various levels, usually including unde ...

in Life Sciences and needs to have a good knowledge of

and local regulations.

Overview

The main function of a clinical research associate is to monitor

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

s. The CRA may work directly with the sponsor company of a clinical trial, as an independent

freelancer ''Freelance'' (sometimes spelled ''free-lance'' or ''free lance''), ''freelancer'', or ''freelance worker'', are terms commonly used for a person who is self-employed and not necessarily committed to a particular employer long-term. Freelance w ...

or for a

(CRO). A clinical research associate ensures compliance with the

clinical trial protocol In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure succe ...

, checks clinical site activities, makes on-site visits, reviews

case report form A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on ...

s (CRFs), and communicates with

clinical research coordinator A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI). ''Good clinical practices principles'' have been defined by Madelen ...

s. Clinical research associates also "ensure the protection of the rights, safety and well being of human study subjects."Clinical Research Training Online, Inc
What is a CRA?
Additionally, a CRA must "make certain that the scientific integrity of the data collected is protected and verified" and "ensure that adverse events are correctly documented and reported." A CRA is usually required to possess an

in Life Sciences and needs to have a good knowledge of

and local regulations.

Certification and practice

Canada

The Canadian Association of Clinical Research Specialists (CACRS) is a federally registered professional association in Canada (Reg. #779602-1). The CACRS is a not-for-profit organization that promotes and advocates on behalf of its members in the field of Clinical Research and Clinical Trials. The CACRS has a comprehensive accreditation program including the Clinical Research Specialist (CRS) designation, which is a professional title conferred by passing a qualifying exam. Applicants holding a doctorate degree in medicine or science are required 2 years of prior experience whereas bachelor's degree holders are required 3 years of prior experience prior to taking the qualifying exam.

European Union

In the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...

, the practice guidelines for CRAs are part of

EudraLex EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes EudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 - Pharmaceutical Legislation. **Volume 2 - ...

India

In India, a CRA requires knowledge about New drugs and Clinical trials Rules, 2019.

United States

In the United States, the rules of good clinical practice are codified in

Title 21 of the Code of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (O ...

CNNMoney CNN Business (formerly CNN Money) is a financial news and information website, operated by CNN. The website was originally formed as a joint venture between CNN.com and Time Warner's ''Fortune'' and ''Money'' magazines. Since the spin-off of Time ...

listed Clinical Research Associate at #4 on their list of the "Best Jobs in America" in 2012, with a median salary of $90,700. 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".Society of Clinical Research Associates
/ref> The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program in order to create an internationally accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials. SOCRA provides training, continuing education, and a certification program. A CRA who is certified through SOCRA's certification program receives the designation of a Certified Clinical Research Professional (CCRP®). The Association of Clinical Research Professionals (ACRP) provides a certification for CRAs, specific to the job function performed. The ACRP offers the designation of 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.Association of Clinical Research Professionals
Eligibility for the CCRA Program.
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," in order to ensure that the person will not have the opportunity to alter any data. The applicant must also show that they have worked a required number of hours in accordance with study protocols and Good Clinical Practices, including making sure that

adverse drug reaction An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...

s are reported and all necessary documentation is completed. The number of hours that must be completed performing these activities is based on the level of education achieved; for example, someone who has only graduated from high school must perform 6,000 hours, but a registered nurse, person with a bachelor's, masters, or doctorate of medicine degree must only perform 3,000 hours. The ACRP's CRA certification program is accredited by the

National Commission for Certifying Agencies The Institute for Credentialing Excellence (ICE) is one of the two main U.S. organizations that accredit personnel certifications or certificates. In November 2009 the ICE formally changed its name from the National Organization for Competency Ass ...

(NCCA), the accrediting body of the Institute for Credentialing Excellence.National Commission for Certifying Agencies.
/ref>

Accredited Programs

ACRPCCRPSSOCRA

References

External links

Association of Clinical Research Professionals (United States and United Kingdom)Certified Clinical Research Professionals (United States)Canadian Association of Clinical Research SpecialistsClinical Research Association of Canada (Canada)Clinical Research Society - Certified Clinical Research AssociateSociety of Clinical Research Associates (United States) Best Clinical SAS Training in Hyderabad (India)
{{Pharmaceutical industry by country Clinical research Health care occupations