Clinical research associates (CRAs) ensure that a medical product is safe and effective before it is placed on the market. CRAs are in the laboratory at all times throughout a trial to maintain laboratory safety and record the trial’s progress, from its earliest development stage to its final outcome. Often, CRAs arrange for the product to first be tested on healthy people. They then recruit volunteers who suffer from the illness the product seeks to remedy. Even after the product has been deemed safe enough for market release, clinical researchers continue to supervise product-related trials to assess any side effects it causes so they can add them to the product’s data.
Many clinical researchers work for the pharmaceutical companies who are manufacturing the product to be put under trial. They may also work for hospitals and contract research organizations (CROs). Their duties revolve around knowledge of clinical research protocol. Principally, they supervise and record the trial through each of its developments and liaise between the trial’s scientists and supervisory committees. They write trial protocols, determine the fitness of the study’s facilities for a particular trial, and prepare final reports for publishing after a trial’s conclusion. They also present the trial for approval by steering and ethics committees, create case record forms (CRFs) for data collection, and affirm that the information on those forms agrees with notes taken by patients. Moreover, they discuss the trial’s outcome with a medical statistician who documents the technical aspects of the trial for future reference. Their duties vary in scale depending on their seniority and whether they work on a full-time or contract basis.
Jobs in clinical research also vary in flexibility. CRAs may work either in-house for a pharmaceutical company or a hospital or on a freelance basis for a CRO. They usually travel, especially if the company they work for is internationally-based. They often work overtime as they push the trial to make its deadlines. On average, those who have clinical research jobs in the US make about $32,000 per year at an entry level. Their salaries rise in step with their experience, with many of them making about $55,000 per year at an associate level. Private companies, such as pharmaceuticals and hospitals, usually pay higher salaries, with senior-level CRAs earning up to $60,000 per year.
Those who want to enter jobs in clinical research must earn a Bachelor of Science degree, either in chemistry, biology, or another life science. Furthermore, clinical research demands expertise in laboratory safety and fitness protocol. As such, it demands the ability to assemble an appropriate laboratory setting for a certain type of trial. Entry-level clinical researchers who have completed an internship are more desirable to employers because they have hands-on laboratory experience. Accreditation by a program from the National Accrediting Agency for Clinical Laboratory Sciences further distinguishes entry-level CRAs from their hiring pools. Proficiency in data-entry computer programs is also beneficial, as is familiarity with experimental design and data analysis. Lastly, a full understanding of the Food and Drug Administration’s regulations for developing medical products is essential for ensuring a trial’s compliance with government regulations.
Clinical research employment will continue to expand for clinical research associates. Continuing advances in science and biotechnology have made room for many new clinical trials that need the guidance of CRAs. The greatest job demand comes from the pharmaceutical industry due to advances in many types of prescription medications. Increasingly, many of these jobs demand specialization in a certain medical field in order to determine the best clinical trial setting for a certain medical product. For instance, a CRA who specializes in a type of pediatric cancer would know the safest and most effective laboratory setting and procedures for a trial corresponding with that illness. This CRA would be the prime candidate for many permanent and contract jobs demanding this specialized knowledge.
Since specialization is becoming a greater necessity, many clinical research associates are opting to complete master’s programs in a chosen field, such as oncology or cardiology. Often times completion of a master’s program entitles them to become high-earning project designers and work on a freelance basis. This allows them to work on their own time as a contractor for many different employers, as long as the same type of specialization is required.
Those who work in clinical research are involved in one of the most exciting fields in history. Many CRAs express a sense of gratification for having helped release medical products that will ease the suffering of many people. These positions are ideal for those who can memorize large amounts of information and prefer to channel their scientific knowledge toward documentation rather than hands-on work.
