I guess it depends on what role you decide to pursue. When it comes to clinical studies where it involves dealing with patients, then I think a clinical background may be necessary. Dealing with different types of people isn't always easy, and the skill to remain calm and interact with them accordingly requires some experience. However, I don't think its necessary to have a clinical background if your role is a Statistician in clinical research. The skills for this role doesn't involve dealing with patients, so the clinical background isn't necessary. I'd say that having the knowledge associated with clinical research is necessary so that it is understood why certain procedures are done.

From a little bit of research, it seems very apparent that prior experience is required for applying for a role in clinical research. I agree with amandaally1029 thoughts that it varies for different roles. However, a sponsor actually requires the company to keep all its clinical researchers CV's on file because they request to see the researcher's skills who will be monitoring their study. Getting a role in big pharma company with no experience is slightly easier in this case as they can absorb more people and offer internships or trainings. But CRO's or smaller companies usually require a good amount of experience so that it is easier for them to gain a project.

It is not necessary to be from a clinical background. Basic knowledge of human biology would be helpful in this profession. Also, if a person is well enough to do this profession he must be very clear with the processings that takes place in this place. So, ultimately he would be clear with the clinical background ig the clinical trials. It is not necessary to be from a clinical background. But it would be an additional aspect that serves them if they are from the clinical background. They have an extra knowledge in delaing with things.

I can understand clinical experience being desired for an investigator, however research experience and good communication/people skills seem to be more important. While clinical experience icludes patient interactions and the administration various treatments, unless completion of the trials requires some specialized knowledge of a treatment or procedure, I have to agree with amandaally1029 and akshayakirithy that a clinical background is not a necessity.

During my Undergrad, I interned at a Neuroscience Lab where we conducted subject based research. myself and my PIs met many of the same responsibilities to that of a CR team. While one of my PIs did have clinical experience, it was not necessary for all of us to have clinical experience to properly conduct research. therefore clinical experience should not be a requirement for CRA positions, especially positions such as sponsor or CRO.

I think it doesn't depend on the role you are taking in the clinical research, having a clinical background will always be a plus for all the roles. However, the necessity of the clinical background is more important, or in other words it is required to have a clinical background, once you are dealing directly with patients. If you have that background, you can determine the progress of the patients, and if this specific patient has a certain health situation that will result huge sides effects caused by the tested treatments. Looking at it from the hiring point of view, you should have a background in nursing, or scientific research in order to get a job in clinical research. Now, if you background is in art and literature, there is little you can do to qualify for a job in CR unless you have a minor in science that might help you get into a good training program.

Having a clinical background gives a biomedical engineer ability to solve clinical problems. Biomedical Engineers work with a broad range of professionals ranging from other engineering specialties, to basic laboratory scientists, to physicians and nurses,so if you want to be at the forefront of the role you in, having a clinical background will be a great tool.

I think having a clinical background is a great advantage. It may not be a necessity depending on your roles. After college, I was working in a clinical research lab in a hospital as a Research Assistant (RA) for two years. I came in without any experience in clinical research. Since it was a very busy lab with lost of simultaneous research studies going on, we, RAs were responsible for most things mentioned in the lecture from creating flyers, contacting subjects, consent subjects (consent forms, HIPPA etc), scheduling (matching with doctors), run experiments and especially, know what to look for and who to ask questions/who can give you the correct answers.
That was the RA position, I think for a higher position such as study coordinators, PI, it's more important to have a clinical background because there are so many little details, documentation, deadlines. My study coordinator came in at the same time I started working there and she started as an RA for 6 months to prepare to be a study coordinator.

Based on my experience in the medical field as an EMT and as an Engineer, I can see how having a clinical background is paramount when it comes to working with doctors and other health care providers. I can say that knowing the proper medical terminology is important for excellent communication. The mentality between an engineer and a doctor is different, engineers focus on solutions based on theory and application and efficency, however there are some solutions that only those that have had experience can understand on how to tackle on situations; this comes with hands on experience. Another important aspect to having this experience is the ability to talk with patients with proper manner and mindset, speaking to patients about sensitive topics following HIPPA regulations is very important and a must.

I work at Sloan Kettering Cancer Center. We perform a lot of clinical trials. Most if-not all PIs for prospective clinical trials, have clinical experience and have been involved in other clinical trials. Some PIs have relationships with industry and perform a lot sponsored studies. I think lower level positons such a junior level monitor, junior statistician don't have to have clinical experience but will hopefully have knowledge of good clinical practices and have gone through the proper training for these roles. 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 trainingss.

On the engineering side, we usually contract work out to a company that has experience developing FDA approved devices and have knowledge of what is necessary to build a functional prototype for clinical trials. These engineers have expertise in how clinical trials are performed and what is required for a functional prototype to test.

Clinical background is essential in clinical studies because majority of the roles you play has something to do with human life and in order to be successful in performing the task you need clinical knowledge. As stated in the question, a statistician for example does not require biological background in analyzing or developing a code for the clinical trial but will ease it's job if he/she can relate, that is why we have biostatician. To have understanding of functionality of the product in human will help accomplishing his job better.

I don't think it is necessary although, having clinical background would certainly help. Every place that hires a new employee will go through the training and that should cover up whatever they are expected to do. Therefore, it is not necessary to have clinical background at all.

People who have chosen majors that coincide or overlap with healthcare are generally inclined towards knowing and understanding human body and its functions. Their mindset is geared towards working for solutions from a clinical perspective while engineers from other backgrounds tend to have mindsets that are focused on a direct problem-to-solution type of an outlook without the intricacies of problem solving from a clinical view point.

To give an example: while I was working in a CRO in India I knew a few co-workers from clinical data management (CDM) department whose role was to create CRFs, consent forms and other types of forms for clinical trials. The work done by them is usually following the instructions from their project leader word-to-word and getting the job done. As content from CRFs is usually reproduced and replicated from similar previous clinical trial studies, one would think not much thought is required in creating these forms. In one of the scenarios, a batch of CRFs had fields to be filled out in the symptoms section that is not even related to the present study but were included in the form because most of the content in the form was reproduced from another study. While these details can be missed out by a project leader, a clinical background person creating these forms can easily spot the unnecessary fields and bring it to the attention of the team or project leader regarding its relevancy and omit unnecessary information thereby boosting efficiency and quality. Therefore a person from a clinical background for the same job helps in efficient management of time, resources and money as compared to re-doing, recalling or re-printing all the forms from the work done by a non-clinical background employee because he/she does have clinical experience or inclination.

I agree with amandaally1029 that the necessity of a clinical background depends on the role that one decides to follow. I would say that roles such as Principal Investigator in clinical research, for instance, requires a clinical background because of the nature of the tasks carried out. This is an individual charged with the responsibility of preparing, conducting, and administering a research grant in strict conformity with the relevant laws and regulations. Having a prior experience is, therefore, a necessity for a one to take up the role of a Principal Investigator. A clinical background certainly has its advantages, especially for an individual in a managerial level. While many people can work in the CRA profession without having a clinical background, for best performance, one should have a high IQ, drive, and an affinity for healthcare.

Having a clinical background may be advantageous to understanding all aspects of the research. It may also be advantageous when dealing with patient care, collecting data on treatments effectiveness, studying and reading medical journals, evaluation of previous research and research studies for publication. It could be that individuals with clinical backgrounds are preferred due to familiarity with various rules and regulation. An example of such regulation is the Health Insurance, Portability and Accountability Act (HIPAA) which was put in place 1996. A section of this law includes the provision that impacts the management of health information. Possessing good documentation/reporting practices and verbal/written skill which nurses and doctors have acquired throughout the years makes them a better fit due to clinical trials being strictly regulated. These skills allow better communication to parties outside the research industry. Clinical trials involve individuals from various walks of life. The success of this research is based on all individuals understanding each other that is why candidates with clinical backgrounds are preferred.