As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or other kinds of technical workers who interact directly with patients.
On the other hand, there are a lot of people without the clinical background who can and do work in this profession, though it may be an uphill battle.
What are your thoughts on the necessity of a clinical background? Perhaps this is different depending on the role, e.g. as Principal Investigator, CRA, Monitor, Statistician, etc.
The profession of CRA is one in which I considered applying. Most of the positions all required some background/ experience. While I understand the desire to have an applicant with prior knowledge, I have two potential issues with this (thanks for asking Dr. Simon): 1. It is difficult to garner experience if everyone wants experience and 2. It presents quite a conundrum for those who are potentially considering this field as a second profession. Both are issues for me. I do not have the experience and it is hard to get since this is as a second profession. The benefit of having some experience is great, but I think it would be quite necessary for the highest tier positions. How can one with no experience work in these roles? Perhaps a mentorship program would be good for those who are trying to transition into these various fields.
In regards to the CRA, monitor, and statistician, from my previous background, it is a plus but not required that individuals what is most important is that they have educational background and knowledge in sciences and some health care administration/ health information management. Understanding that Clinical trials is the experimentation of humans to find a solution to a disease and/or disorder means that there needs to be fundamental understanding. Also just as important, when creating medical devices, the staff needs to understand the basics of CRA with respect to persons to positively effect the clinical study. In my personal opinion, companies have swayed more towards hiring clinical background (healthcare personal) in my opinion due to the lack of people in the field and more so for bedside manner. To me it is a double-edged sword, you have hire: Sponsor, Principal Investigator, CRA, Monitor, Statistician with the proper education but they do not have bedside manner or know how to correctly interact with participants/patients. The opposite spectrum includes hiring nurses, DNP, and PA’s and they have no experience or knowledge past the core undergraduate science level and to me that is a problem. I did notice while doing some job recon that if you had both: a medical professional with an CRA or a advanced science educational background with a CRA (and without) the offering salary was increased.
I believe being a Clinical Research Associate should require a clinical background. I believe that clinical research involves being hands on with lab equipment, or subjects that are involved within the clinical trials. The trials could include animals or humans either way I believe without that clinical background there would be more room for error, because they did not learn the hands-on clinical care which is important when conducting experiments and research.
I agree that a clinical background would be beneficial if you are pursuing an Investigator job. The experience of working with patients would help when communicating important information regarding the trial, and the science background would help Investigator translate the trial information into plain English for participants. Still, it would be less of an adjustment for something that is more business or paperwork oriented if the employee had more of a Regulatory background or a business background. Understanding business jargon and the importance f keeping certain stakeholders happy for the sake of the pharmaceutical or medical device company.
For the different roles in clinical research, I believe that having a clinical background would be a plus, but not necessarily a requirement. When considering positions like a statistician, you wouldn't think that it would be too important to your job functions to have a clinical background. For example, after doing a job search for a Principal Statistician, job descriptions listed necessary criteria that included performing statistical research, statistical programming, and supporting clinical trial efforts at different phases of drug development. It did also mention prior experience designing and performing clinical trial simulations, so an exposure to that type of work would be a plus. But, I don't think that not having a background as a nurse or physician would limit your qualifications.
As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or other kinds of technical workers who interact directly with patients.
On the other hand, there are a lot of people without the clinical background who can and do work in this profession, though it may be an uphill battle.
What are your thoughts on the necessity of a clinical background? Perhaps this is different depending on the role, e.g. as Principal Investigator, CRA, Monitor, Statistician, etc.
I don't think it is important for the sponsor to have a clinical trial background. Because the sponsor can be companies, I think that as long as they are efficient in securing the funding, they can essentially outsource for the jobs that require a high acuity for the logistics of clinical trials. A principal investigator should have a few years of running a clinical laboratory. They should be well versed in GLP. The CRA and statistician position should have some experience in the clinical field, but I don't think it is required to have clinical trial experience at the entry levels. However, the high the position is (e.g., statistician III or CRA III) should have clinical trial experience because the monitor has to be well versed in clinical trial logistics because they are responsible for overseeing the progress of a clinical trial.
As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or other kinds of technical workers who interact directly with patients.
On the other hand, there are a lot of people without the clinical background who can and do work in this profession, though it may be an uphill battle.
What are your thoughts on the necessity of a clinical background? Perhaps this is different depending on the role, e.g. as Principal Investigator, CRA, Monitor, Statistician, etc.
As a scientist who has been desperately trying to enter this sector... I have bias and I'm not ashamed!! I see the benefits of having people who have been in the clinical setting before. I understand. However, if you don't give young scientists the chance; if you can hire just two or three fresh degrees to train; I think your company is the problem. Do you know how many new scientist can't get a job in the field at all? How many people are reduced to work minimum wage, or out of field because the science/medical field is so hard to secure entry level jobs in? Okay. I'm done. But the point is, give someone a chance. We're not asking for the whole team to be new but 5-10% isn't asking too much.
Experience is always valuable. That is even more important in clinical research. There is huge liabilities that are present when conducting research on human subjects. I can understand why experience is so important. My mom recently retired as a clinical research nurse at the university hospital. She spent 25 years doing clinical research on premature babies. She finally decided to retire because people coming behind her lacked the experience necessary to be as effective as possible. That to me is more of a failure of the system to adequately prepare those in clinical research to effectively do the job. Encouraging more interest into STEM can prepare the next generation to have the experience necessary to perform.
Having a clinical background seems to be used as a filter by many companies to recruit talent with a certain background and make it so those who do apply without that experience and get in-are exemplary. From that perspective, I think that ultimately its good to have that requirement. It doesn't make it impossible to get into these Clinical roles, but much more difficult, which I believe is the intent by design. The current company I work for, for example, requests that you have a background in medical devices; not all staff have this background, but of those who don't, they gear themselves more toward a focus on producing acceptable medical devices than they might have otherwise.
Using another perspective, I've worked in the medical field in the ER before my current position. I believe having that background of directly working with patients would allow me to work more effectively in a clinical role. You might have a different perspective to bring to the table in consideration of patients or how things typically take place in these medical settings that you might be able to contribute to the protocol that you're writing from a CRO, etc.
