Relevant research experience is critical to landing a CRA or coordinator position. Some of the easiest ways to get involved include recruitment or business development. Once you have enough experience and are ready to apply for a CRA or coordinator position, interviewers will expect you to demonstrate a clear understanding of fundamental aspects of research.
Starting a new site doesn’t have to be an impossible task. One of the first things that should be done is to incorporate the new business and obtain an EIN number. After a site is set up, the next challenging steps revolve around finding and running a study.
Some site owners worry when they hear about an employee being unhappy and considering opening a new site. While it may be normal to worry and prevent them from doing so, a better strategy might be to help the employee. Doing so can leave an open door for negotiating partial ownership of the new site.
Site owners will have to keep patients, PI and sponsors happy if they want to keep their site running. Most sites will have little trouble with patient retention and keeping the PI engaged. Conversely, keeping pharmaceutical companies happy can be challenging because it demands that your site follows various protocol specifications and maintains a positive relationship with CRA’s.
Adverse events are not always easy to identify. Some investigators will often link symptoms to the medical history because they don’t believe that the symptoms are an exacerbation of symptoms due to the investigational drug. While this is true in some cases, medical monitors can always be contacted for a second opinion.
Being a CRA can allow people to provide guidance to sites as they conduct clinical trials. Because of the many sites that must be overseen, many CRA’s are expected to travel almost 70% of the time. More experienced CRA’s can reduce the amount of time they travel and can then focus on personal matters or on family.
All members of the research industry should make sure that they are following up with others. Following up can be the difference between getting a job or not. PI’s and sites that are able to follow up with other members of the research industry can ensure that they are heard.
Many physicians are not aware that one of the biggest benefits of conducting privately sponsored research is that funding for it is more reliable and does not depend on government funding. Physicians who are involved in clinical research can also benefit from having an additional stream of income. One of the drawbacks of taking the role of the PI in a study is that there can be a large amount of regulatory work to be maintained, but even this can delegated to other staff members so that physicians can focus on patient safety.
Paying a PI can be challenging because of the central role that they play at the research site. For this reason things such as the PI’s level of involvement must be taken into consideration. Other things to consider include whether or not the PI will be a partner or a contractor.
The research industry can be difficult to enter. One way to enter is at the research site level by working as a research coordinator. With enough coordinator experience, anyone interested in becoming a CRA may be able to learn what sponors expect from sites.
Patient recruitment is one of the most challenging aspects of running a clinical research site. Some sites tend to worry about the cost of advertisement but these costs are often covered by sponsors. Sites should be aware that IRB approval is a prerequisite for study specific material but is less important for site brand building.
There are many factors that can slow the rate at which a site is able to startup and enroll patients into a study. As stated by the guest in this video, the various factors can be categorized into four groups. One of the major factors that can slow down site enrollment involves CRO's which are often under pressure from the sponsor to perform well and may delay sites during budget negotiations.
This video reviews several viewer questions that address CRO interactions, research site development, and patient recruitment. During the discussion, the profitability of a CRO versus that of a research site is compared, with sites appearing to have higher overhead margins. Additionally, the current trend in which sponsors are starting to rely less on CRO's has affected the demand from CRO's.
One website that is often overlooked and underappreciated is clinicaltrials.gov. This website is so powerful that it can be used to reach out to study directors. This website can also be used by patients or sponsors in order to learn about active studies.
Many people are not aware that private clinical research is different from academic and is typically sponsored by pharmaceutical companies. Private research is conducted by physicians who undertake the role of PI and delegate tasks to other staff members so that they can maximize the amount of time spent with their patients. Of the people who help the PI, research coordinators are very important because they do a lot of the work for the PI.
Some physicians are afraid of referring patients and often discourage participation in clinical trials because they are not familiar with the research industry. However, the opposite might be true as clinical research requires that careful attention is given to each patient thereby increasing the patient's quality of care. Clinical research also has a strong sense of ethics which is embedded into every protocol and can be seen in oncology studies which do not allow experimental treatment to be compared to placebo.
Entry level positions for CRA's are in high demand so anyone thinking about applying should know that there is a lot of competition. Candidates should have a general understanding about how sites work and should be able to answer questions regarding specific situations such as the approval of a new protocol amendment. Those who are familiar with research should also make sure that they are familiar with the STAR method when answering questions.
Most people who are interested in the clinical research industry believe that they can only enter as a CRA. Others erroneously envision doctors as being the only ones involved with research. In reality however, doctors serve as principal investigators but there is a multitude of individuals who oversee regulatory documents and data collection.
Extension studies guarantee that patients will receive active study medication. These studies are usually approved for existing studies and serve as a means to improve patient retention. While some people may be confused about the difference between an extension and an amendment, it must be made clear that the two are not the same.
Most people don't know that they might have skills that can transfer into clinical research. Such skills include being able design websites and designing them for sites. Once inside the field of research, it is possible to apply years of research experience into providing research services such as independent monitoring or consulting.