As Dr. S listed for us, the roles of a clinical project team are as follows: Clinical Project Manager, Clinical Research Associates (CRA's), Monitors, Regulatory, Statisticians, Investigators, Site Coordinators, SROs, CROs, Centers, Labs, IRB's, and Recruitment Organizations.
If you had to pick one of these roles to follow (except for Project Manager), which one would you choose and why?
I would personally choose to be in Monitoring because its an interesting part of the trials -- you're essentially there to ensure that everything is following through as necessary. Therefore, I would be a part of every step of the process.
I would choose to be in the Regulatory group because it is an exciting and ever changing environment. Due to constant changes in the world wide regulations the group that is making sure the trials adhere to current regulations has a very important role. This position has a of job security because it is an ongoing process. I have been spending this week working with my company on what is required for us to meet the new EU MDR requirements that were released last year. It is an immense amount of work involved, not just to meet the requirements but to continue to meet the requirements after the EU MDR implementation date.
I would pick the broad category of being an investigator. More than likely be a medical device engineer of whatever the specified area of expertise, which the clinical trial is being done. I like solving problems, therefore, being an investigator allows me to have a challenge set before me. The challenge of figuring out what the problem is and therefore conducting experiments for possible solutions. Being involved in the medical device development area as an investigator would motivate me to produce products that allow me to change the quality of life for those in need of a boost and to promote joy.
I would pick to be part of the clinical research organization (CRO). They are the ones that can run an entire clinical trial. I would pick this role because I like to be hands on with what is going on. I don't just want to see the results written on paper. I learn best when I can physically see what is going on and do the work myself. I would like to see the outcomes first hand and see what is going wrong and run tests to see what needs to be changed.
I would like to choose the role of Project Manager. It is the responsibility of a Project Manager for successful initiation, planning, design, execution, monitoring, controlling and closure report. It works and engages with all the departments in one or other way so I would like to see myself as a Project Manager so that I can learn about the whole management process from initiation to closure. I would love to see how would I manage this things and this role.
I think I would like to a Clinical Project Manager as @Devarshi mentions as a project manager you are able to interact with all departments through the different phases from initiation to closure. It would be exciting to oversee a clinical project from start to finish. I think that would be a very rewarding experience. I also think it would be very interesting to be on the Internal Review Board, you would get to see all the clinical trials being performed at your institution and review the protocols. I currently work at Sloan Kettering and we have so many clinical trials that we have two IRBs, IRB-A and IRB-B. I think it would be interesting to read all the different protocols and see all of the new and exciting methods/devices from a scientific perspective. You would be exposed to a wide array of protocols which sounds very exciting. On the other hand it is a very big responsibility approving the protocols, but I think the exposure to exciting science would make it enjoyable.
I would like to work in the Regulatory department if I was part of a clinical project team. Being someone who is always thorough with every step she takes, always planning two steps ahead and always ready with a plan B, the regulatory department would be an ideal fit for me.
For me I will choose CRA , as a CRA you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is one of the clinical science jobs that offers many opportunities to choose the best environment for your career goals. AS a CRA, you will be working with patients, physicians, and many other health professionals, which means you more experience in the field.
Finally, as a CRA you could make more than 100K annual salary after 3-5 years experience on the field of medical device or biomedical engineering in general.
I would like to be a statistician . Clinical projects usually collects a lots of data so the statistician summarize the data so that non statistician can understand. A Statistician helps to optimize design, analysis, interpretation of results and conclusion. Statisticians help ensure that experiments are designed, run and analyzed in the best way to meet the study objectives, thus reducing the likelihood of having to repeat experiments, which has time, cost, and potentially ethical implications.Statisticians can work on a variety of aspects, as they do in clinical trials, including study design, randomization, sample size estimation, statistical methodology, and analysis and reporting as well as offering statistical consultancy, training and computing advice. In order to ensure the involvement of the statistician is beneficial to the trial and its team it is important for the statistician to have some knowledge of the area. An understanding of how the results are obtained and the different factors that should be considered in the analysis of the resulting data is valuable. It is also important that the statistician be involved as early as possible.
I would like to choose the investigator because it examines the medical devices before in the market to make sure that the patient is safe. The clinical investigator should also meet with the requirements set by the FDA. Primary role of investigator is to conduct research that contributes to generalize the knowledge of human rights.
I would like to choose the role of being a Clinical Research Associate (CRA) as they are one of the important people of the team that get most of the work done which involves writing a protocol, having the IRB approve the protocol, initiating the clinical trials by training the doctors at the labs followed by enrolling the patients and performing the study on them. This means that as a CRA you will be working with people from different backgrounds such as doctors, patients, other health care professionals which will expand your knowledge and help you gain good experience in the field by interacting with people from such varied backgrounds.
I would choose monitoring as it is the process of keeping track of the project related metrics such as team performance and task duration, identification of potential problems and taking corrective actions required to ensure the project is in scope, meets specifies deadlines and is on budget. It is making sure that the project which is to be implemented is according to the way it is planned. Monitoring will provide the source of information about the project progress.
As Dr. S listed for us, the roles of a clinical project team are as follows: Clinical Project Manager, Clinical Research Associates (CRA's), Monitors, Regulatory, Statisticians, Investigators, Site Coordinators, SROs, CROs, Centers, Labs, IRB's, and Recruitment Organizations.
If you had to pick one of these roles to follow (except for Project Manager), which one would you choose and why?
I would personally choose to be in Monitoring because its an interesting part of the trials -- you're essentially there to ensure that everything is following through as necessary. Therefore, I would be a part of every step of the process.
I would like to be the Clinical Research Associate. I like this role because it seem to required understanding of how to actually implement the study. So alot of visibility into what is going on is available to this role.
@christoph I would also be interested in a clinical research associate, which I technically work as in my current job. My team and I work for clinical testing for potential vaccines. I enjoy working with clinical trials and testing different things in labs and experimenting with different methods to achieve those certain data I'm interested in.
Out of all those options for a clinical project team, I would pick a lab to work in or Clinical Research Associate. It involves the actual research for the trials and analyzing the data. You are very involved in the study and how the product would need to be changed or how it effects the customers. It’s a very hands on job which I enjoy doing. Doing the research for why certain things happen in the trial has also intrigued me. Following methods and doing experiments has always been an interest of mine.
