I agree I do not believe a clinical background is necessary to work in this field. Engineers that have gone through the 4 plus years and are strong in their field should be able to get these jobs without clinical background. I do understand that engineers may not know how to communicate well with doctors or even the patients but this is a trait that can be learned as was said above. There is no reason to have 3-5 years of clinical background just to be able to communicate with doctors or patients. Personally I have witnessed people become scribes which are the people who walk around with the doctor and write down what is said between the doctor and the patient. They were college students with no clinical background. All they did was take a couple classes online to learn all the terminology, rules and regulations. It was a good amount of online classes each three hours each but now they are able to work with the doctor and patients. Maybe this can be a way for engineers to be more qualified to work in this field by giving them a couple classes to teach them all the terminology, rules and regulations.
I’m sure a clinical background is more important in some positions than others, but it is something that is always beneficial. The exposure that one gets working in a clinical setting and having to deal with so many different people, with different backgrounds/beliefs/levels and even prejudices is something that helps you grow not only professionally, by also personally. This kind of experience is the kind that ends up being a win-win because you can apply what you learn anywhere. Also, it is inevitable that you will have to work with people and deal with work related problems, and I think that this is why being exposed to a clinical setting ends up being important, as it is always really helpful in that aspect.
I do not think having a clinical background is overly necessary to perform clinical research. Like any job, you end up getting trained to do things the specific way your employer wants you to do them anyway. The biggest plus to having a clinical background (i.e. RN), however, would be if the patient in the study has an adverse effect to what is being tested. Having a clinical background in that sense would be safer for the patient due to the researcher having experience in acute care.
When analyzing the qualifications for a CRA position, the first factor that comes to mind is what type of clinical product is being put through trial? If a Class III product such as a new pacemaker or a cell-based infusion is being put through clinical trials, then clinical experience should definitely be a must for any CRAs that are interested. If the product however, is a Class I or II device that is not life-sustaining, then the clinical background required for such a position would likely read as "0-2 years experience". These background requirements are put in place not only to account for a CRA's performance in a clinical setting, but also because it's probably what the patient prefers. Anyone who is a patient afflicted with a condition that requires clinical trials would most likely prefer to have a trained professional handle their medical needs rather than a novice. I currently work as a clinical manufacturer, where I process blood-based products for infusion. My position does not require a clinical background, though it also does not require us interacting with the patients who receive the treatments. Although patient interaction is not included in our job responsibilities, I personally believe that a clinical background should be required simply because of all of the mistakes that inexperienced manufacturers make when handling a patient's own blood. The company I worked at prior was also a clinical manufacturing position, but it processed human skin grafts, a decellularized product that posed less risk than a product that is sent directly into the circulatory system. Since this product (called the Alloderm) was acellular, it carried little risk of transmitting diseases since it was treated with gamma radiation, so this type of CRA position would be more ideal for someone with little to no clinical experience.
Simply put, a clinical background should be associated with a position that requires the handling of a Class III device and patient interaction, otherwise for less medical-intense devices a CRA position should prefer clinical experience, but not require it. A quick search on Indeed for CRA positions shows that CRO companies such as Syntactx, requires little to no clinical experience (0-2 years preferred), just a four-year education in science. This is likely due to a CRO's ability to place inexperienced CRAs in entry-level projects, then transitioning them to more up-scale clinical trials once they've acquired the necessary experience. Is it possible to work as a CRA without having to interact with patients? Should CRA experience be required for clinical trials regarding a hip implant? How much risk exactly should a clinical trial carry so that a clinical background is not required?
Folks allow me the opportunity to chip in somewhat.
The field is not an easy spot: lots of trials, even benefits. You'll meet people looking at you this way or that way and making weird conclusions about you. Face it, we are going to be dealing with people of different backgrounds, upbringings, and education. But however you look at it, it will be you in the middle of this inspections from different angles.
Take an example, Prof. Simon at the beginning of his career out there sort of came to what I would call a crash landing on his very first assignment. Someone who may have liked or disliked; respect or disrespected him came up with this crazy assignment: 'You run this project ----'
Young Dr. Simon could not back away from his assignment though he may have had difficulties contemplating how to go about it. He made sure he did not loose composure. He faced it calmly and methodically. Somehow he came up with some solution which worked.
In clinical operations we one will be dealing with operations to do with the human being; not at all an easy feat. What is important here is that no room be left for such things as may lead to Adverse Event Reporting. No matter what responsibility one chooses to take on in the clinical operation field, the preparation - which will obviously be necessary - be: thorough, comprehensive and accurate.
Whoever gave you the opportunity in their establishment will not leave you alone, they will be watching and this could even lead to some benefit - no way to predict the outcome of how you deal with your assignments.
I think it is very situational as to the qualifications for each position involved in the clinical. The investigator is someone who should probably have a clinical background, but may pass if they have certain other qualities. Since they will usually have a team of clinical associates performing most of the procedures, I think the Investigator should have some sort of Project Management experience. They need to know how to delegate tasks, follow a timeline and budget, and be able to manage all of the team members effectively. Part of this management also includes ensuring every single form and document is filled out completely to cover all aspects of performing the experiment. Their duties are not necessarily driven by needing to understand entirely the medical part of the trial. I think the Clinical Research Associate is the person who is most likely to have experience as a nurse or clinical assistant. This is because they need to fully understand the procedures being conducted and be able to interact with patients and have those interpersonal skills. The only exception I think would be a Biomedical Engineering graduate with a master's degree and lots of experience doing research in a lab, preferably having completed a thesis project as well. The data analyst is probably the position that requires the least amount of clinical expertise. Once all of the data and results have been collected, they pretty much just become numbers at that point. I think the person best suited for this would be a Biomedical Engineering graduate with a background in various simulation/analysis software and statistical knowledge in order to dissect the results and display it in the most useful way so as to draw a conclusion.
Going to give a brief summary of the general job responsibilities of a CRA. CRAs is health-care professional who performs many activities related to medical research. Some of those activities can be keeping the GCP’s for monitoring the clinical trials taking place, reviews case report forms (CRFs), communicates with clinical research coordinators, basically a manager as it were. With those tasks listed above and what asimbana has stated it is mandatory for a CRA to have clinical background experience prior to being a CRA. In contrast, if say you’re a statistician having clinical experience is not a must in my opinion. You can and should be able to hire a bioinformatic with a 4 year degree to be able to do the work. Also, the people of the company I am sure have someone who has experience with data collection and how to interpret the data before them therefore, they can help the new employee with such a task.
The necessity of having a clinical background is highly dependent on the role you will have in the clinical trial. All of the roles will be made easier with some level of clinical experience, but they all can be conducted without it. Principal investigators and investigators will benefit immensely form this as they will be in the test center conducting the tests. That means they will be working with patients so and understanding of that dynamic and how working with patients can be will greatly increase their ability to conduct the trials. But for someone who will be doing the statistical analysis of the data the need for clinical experience will be minimal. If the study was designed well then the data will not need much interpreting, just simply taking the data and analyzing the trends to see if the test proved that the new treatment is statistically significantly more effective then the older treatment. In some ways having clinical experience could be a detraction as you may be tempted to look at the data as more than data, when it is important to be objective.
If the job is more desk work related such as a statistician, bioinformatics, ect, a clinical background is not required. I believe a clinical background is necessary if you are are going to directly deal with patients.A principle investigator and clinical research associate should require a clinical background since these jobs entail dealing directly with patients. The clinical background does not have to necessarily be research related. It can also include working as a medical assistant, EMT, and ect. The important thing is that the job involved patient interaction. Even if the job you had involved working with teammates, patient experience is extremely important. It is different dealing with people on a team than patients who are about to undergo some type of treatment. Thats why for the patients sake,clinical background is necessary .
As many students above stated, having a clinical background depends on the role. There are some roles like the PI that require clinical background, this is because the role is usually critical and can't allow much mistakes. Having clinical background means that the person has experience and practical knowledge of the situations. There are other roles that are flexible and can allow an area of learning and mistakes, like the data analyst. Any mistakes done can be undone. These roles don't really require clinical background.
So, the more crucial and risky a role is, the more practical and reliable experience is required.
I believe it is required to have a clinical background, once you are dealing directly with patients. Even though, patient interaction is not included in our job responsibilities, I personally believe that a clinical background should be required simply because of all of the mistakes that inexperienced manufacturers make when handling a patient’s own blood. As a result, I strongly agree that The CRA should have clinical experience as well as the study coordinator or have completed the trainings as mentioned in the lecture. The CQA should have compliance experience in relation to clinical trials or proper trainings.
Obviously having clinical background will help you in the job because you will have basic knowledge experience in all the responsbility of the job. Any background experience of a job is always good to have because if you starting job that you don't know nothing about, you will have to spend more time in trying to learn. Having no experience can lead to mistakes that affect the company. There will be some jobs that won't require background experience but you must learn quick because you can be under review with other people that applying for the job as well.
Clinical research is a huge industry that encompasses many different professional roles – including medical writers, clinical trial managers, and biostatisticians.
Although having a clinical background is the preferred option when applying for CRA positions, I don't think it is entirely necessary. With a strong background in science and the ability to grasp new and complex subjects quickly, a PhD, too, can be advantageous for clinical research. Becoming familiar with the business and regulatory aspects of clinical trials and highlighting your current skills appropriately can make you a strong candidate in clinical research.
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 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 do not believe that it is necessary that the Principal Investigator have a clinical background. I consider it to be paramount that the PI have a firm research background and leadership capability. For example a PI could have a PhD or a masters with demonstrated research expertise and leadership. Additionally, I am not familiar with many statisticians who have a clinical background. Subsequently, if the PI does not have a clinical background I consider it necessary for the CRA or monitor to have a clinical background.
