In lecture this week, we learned about the different roles one can have within Clinical Research, such as a CRA, Data Manager, or Project Leader. Which role do you think would suit you best for your experience/skillset as an individual?
For me, I feel that my experience lends me towards being a CRA or perhaps a Clinical Quality Associate. I've worked in Quality for my current company for a while and although the current industry that I am in is much different from Clinical Research, I believe that I would be able to contribute well and consider myself a good candidate for a Clinical Quality Associate.
It was interesting to get to know about all the different positions within the clinical research realm. Currently in my role I am a research and development engineer at a medical device company but I am really starting to become interested in project management. In the recent months I have learned more about the responsibilities and functions of project management positions and also that it takes some people years upon years to truly master the project management concept. Not only do I feel like I would be a good project manager/leader because I have started to develop the passion and skills for it, I also feel that the challenge itself interests me a lot. Alongside this, any position that could be "hybrid" and incorporate clinical knowledge to it would be a bonus because project leaders do often need to know about the clinical aspects of the devices that are being modified or created within the projects. I would love to know what positions others in the class find interesting and why!
Since I’m currently working as a manufacturing engineer in the medical device industry, I can see myself fitting best in the Sponsor role when it comes to clinical research. The sponsor is the organization actually paying for the clinical trial to occur; in the case of medical device manufacturers, they will sponsor a trial in order to prove to the FDA that a new device is safe and effective before it is released to the market. The sponsor is responsible for actually designing the study and creating the protocol that the study will follow, which interests me more compared to the various other clinical trial roles because it seems like more than just administrative work; you have to be familiar with scientific principles and how your product functions. In my career I’ve had the opportunity to help develop various validation protocols and have taken a Design of Experiments (DoE) course, so I think that experience would definitely help if I chose to pursue a more clinical-focused career path.
I also have experience in quality, specifically the risk management side of medical devices. However, rather than being a Clinical Quality Auditor, I think I would be more suited for being a Monitor. Monitors are responsible for verifying that the informed consent forms have been signed, making sure that the study binder is complete, and overall policing the clinical trial. I would assume this function requires a lot of attention to detail and strict adherence to guidelines, both things I am intimately familiar with having worked in risk management. Monitoring also sounds interesting from a clinical study perspective, since one would be making sure that everything goes smoothly. I feel as though I would be good at making sure that the rules are being followed and that everything is in order.
Given my background in research, medical devices, and clinical trials, I feel that I would be able to take on any role comfortably after the typical training and learning curve procedures. However, in terms of personal preference and overall skills, I believe I would be best suited for a role as a data manager; conducting statistical analysis and determining trends in data or providing a quantitative assessment of what is being tested. Alot of my work experience revolved around the usage and manipulation of data in order to provided summaries, graphical analysis, patterns, and converted results.
I have had the opportunity to be involved in the developments of such trials when I was under my research role. I vastly underestimated the amount of documentation, time, approvals, and calls you have to do and honestly was a big curve to get a handle on to. My later roles within research became more focused on Data, so to answer the post that is where I'd go if I was in the interest of GCP. I say that because data analysis is something I do so regularly that I'd be comfortable to keep doing it in a similar fashion. But provided the opportunity I'd much rather do industry work than research.
With my skillset I believe I could be successful in the role of a clinical research associate (CRA), a data manager, or even a quality associate (CQA). In my current position I am a research scientist and complete several studies a week along with analyzing the results of these studies. During these studies I interact with QA a lot and follow the same protocols they have to enforce. With this knowledge I believe I could transition well into a CQA position.
With my skillset I believe I could be successful in the role of a clinical research associate (CRA), a data manager, or even a quality associate (CQA). In my current position I am a research scientist and complete several studies a week along with analyzing the results of these studies. During these studies I interact with QA a lot and follow the same protocols they have to enforce. With this knowledge I believe I could transition well into a CQA position.
I think investigator and study coordinator are two roles within clinical research that suit me best. I have experience working with doctors and patients. I have been working in my family's private medical clinic for several years. My responsibility was to interpret to the patients their medical tests which include blood tests, endocrine tests etc. The study coordinator usually works with the doctors and they collect data from the patients' medical records. I think with the right training I can do this job. Also, some of the investigator's roles include assessing patient compliance and documenting interaction with subjects. My ability to demonstrate and explain medical tests to patients offers me an ideal chance to work as a clinical research investigator.