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Clinical Research

Learn about clinical research and the professionals that work in the field.

Clinical research professionals preside over clinical research trials. [©Jupiter Images, 2009]
©Jupiter Images, 2009
Clinical research professionals preside over clinical research trials.

Clinical research professionals preside over the many clinical research trials that are conducted each year. These trials hope to gather information that will improve various aspects of medical care, including treatment, prevention, diagnosis, screening and quality of life. There are various professional clinical research positions that work together to help make these trials happen. Each position requires training and certification guidelines, some of which can be achieved through both classroom and online courses.

Clinical Research Coordinator

The clinical research coordinator (CRC) is the entry-level member of the investigative team. However, they are also the member of the team that is responsible for the nuts and bolts of the clinical trial process, including:

  • Preparing and ensuring the quality of the trial site
  • Screening, recruiting and enrolling trial participants
  • Dispensing and maintaining drug supplies for trials involving medication
  • Completion and quality control of case report forms
  • Maintaining source documents

The minimum education required for a CRC is a high school diploma; however, a Bachelor of Science degree will make the candidate more appealing to employers. To become a certified CRC, a candidate must have at least two to four years of experience in CRC-related tasks. Experience as a CRC can also provide a foundation for becoming a clinical research associate (CRA).

Clinical Research Associate

According to the Academy of Clinical Research Professionals, a CRA is responsible for monitoring how a clinical trial is administered, as well as its progress, on behalf of the sponsor of the trial. To ensure objectivity, it is imperative that the CRA is independent of the rest of the investigative staff and not employed by the institution conducting the trial or the site of the trial. The initial education for a CRA includes a medical or science background, such as nursing or physical therapy, or a B.S., M.S., or Ph.D. in a science, usually with a focus on research. Depending on employer preferences, prospective CRAs may also need to partake in a CRA training program. CRAs are usually employed by a research, pharmaceutical or educational institution.

CRA certification is not required but will often make a candidate more appealing to potential and current employers. The requirements for CRA certification vary according to an applicant's previous educational background. The following work requirements must be met in order to sit for the certification exam:

  • Those with a bachelor's or RN degree and above will need two to four years of work experience as a CRA.
  • Those with an associate's degree will need three to six years of experience.
  • Those without secondary degrees, such as LPNs and medical assistants, will need four to eight years of experience.

Certified Physician Investigator

The Certified Physician Investigator (CPI) is the member of the clinical investigation team who takes responsibility for the safety of the trial. There can be several CPIs on a trial, all sharing the responsibility of monitoring, supervising and designing the study as well as making sure the trial is conducted in a safe and ethical manner. To serve as a CPI, a person must hold an M.D. degree or equivalent. Though not required, becoming a certified CPI provides proof that the physician has met specific professional standards. In addition to a medical degree, a CPI must either have two years of experience with the duties of a CPI or have completed a clinical research degree or clinical fellowship program.

Certified Research Training Options

There are many online education opportunities for becoming a CRA and CRC. Research should be done to ensure that such schools adequately prepare students for the responsibilities involved with becoming a CRA or CRC. There are also established universities that offer training courses, such as the American University of Health Sciences and California State University San Marcos.

Training opportunities are also available for those interested in becoming a CPI. According to the Association of American Medical Colleges, many medical schools and teaching hospitals have established clinical research training programs. Many of these are aimed at preparing medical students and medical professionals in becoming a CPI. The employers themselves may also provide more specific training. For example, the National Institutes of Health Clinical Center provides an online training course that is required before approval to perform clinical research in the Institute's Intramural Research Program.

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