Similar to some posts above, I would also like to be an investigator. It seems like they are directly involved in the meat a potatoes of the trail. But I also think the IRB role is interesting as well. It sounds like the IRB role is a quality role to approve the protocol and ensure transparency with the participants about the trial details. The IRB ensures that the risks are reduced and are outweighed by potential benefits and reviewing research in order to advocate for the rights and safety of people who take part in research, both before the research starts and as it proceeds.
I would like to become a Clinical Research Associate if i would take part in a clinical research. It directly involves in carrying out clinical trials to test the effectiveness, safety, benefits and risk associated with the drug/ device so that they can be marketed. This interests me because i can be responsible from start till end of clinical trial in setting up trial and monitoring it throught so that it is safe for marketing.
I would prefer to be clinical quality assurance, because it gives me chance to go over complete process. It also helps me find different process or find different issues that the whole clinical process could have. Another process I would prefer is being principal investigator, because it will give me a chance to look over the study and help the people with making the process go smooth. It also would be give me a better chance and deeper understanding of the solution we are trying to solve and maybe come up with different solution for the process.
I think I would like the role of Clinical Quality Assurance Auditor(CQA). Any clinical trial will have a lot of paperwork from the consent forms to the update of the procedure. This might be a tedious job but I believe it is one of the most important ones. If there is misinformation about anything, it can cause that certain results to be thrown out or possibly the entire clinical trial itself. The procedures and information given to the patients must be clear and correct otherwise it will create misguidance. Also having this role, will allow to interact with all the other departments involved in the trial and also the other departments of the company.
Based on the rules on the slide should I would like to have the role of Clinical Project Manager. I enjoy management roles and feel this is something I could perform. The main role of a clinical project manager is to plan, direct, or coordinate clinical research projects, evaluate and analyze clinical data. This is a very important role because the clinical manager is basically the overseeing of one or several clinical projects and is there to ensure that everything is being done by ensuring that all workers are engaged in the clinical research project, complaint with protocols and the overall objective on the trail is being met. After working in the position I would definitely want to advance into a Director of Clinical Research position which has more authority and responsibility of a clinical research department.
I‘d like to play a role of investigator,since I love research. I'd love to study whether the drug I am working on is safety when people taking it. This role is very important because investigators should be responsible for the result of clinical trials. This role is also burdensome, since if something goes wrong, for example, patients have some horrible side effects after taking the pills even if the result is positive, the responsibility will goes to investigators. Therefore investigators should be very careful and make a good plan to measure all the side effects the pills might have.
In clinical research trials Clinical Research Coordinator plays an important role, he is the organizer of research labs. His main role is to closely study principles of investigation. It is important for the overall growth of the process. The duties comprises of ensuring that study is in compliance of the protocol and practices, create work study, train staff, communicate, act as per schedule, gather reports from lab, collect all information and participate in conferences. There is pressure of meeting timelines for reporting to sponsors.
I would like the role of CQA - clinical quality assurance. CQA inspects the documents and processes clinical trial data and ensures that testing follows proper guidelines as stated by good clinical practice (GCP). CQA can give exposure to all aspects of the clinical trials process, as they are involved in ensuring compliance in all areas. Serious failures can be dangerous for patients, very costly and damaging to a company’s reputation. Thus they tend to attract a lot of publicity and the role of CQA is therefore very important and high profile.
I think I would want to work for the sponsor company as the person putting the clinical protocols together. It seems like it would be an interesting position where not only would I get to prepare procedures for people to follow but also have the chance to interact with doctors and the FDA regarding the clinical studies that we are conducting. Because of that, I feel like there's a lot you can learn from this type of position. Also I would get to travel and choose who I want to work with as the investigator.
I would prefer to be a sponsor for a clinical trial. They are the one's who actually develop the trial and create the case for why it's necessary. My background is in product development so the responsibilities of the sponsor aren't novel for me. I have written protocols for mechanical testing and defended why I chose to develop the test the way I did.
My reason for picking the sponsor is not only because it is a territory I am familiar with but also because it has responsibilities I enjoy doing. I enjoy developing the tests and developing the team necessary to run the trial. It's an interesting role because you get involved with the different aspects of the trial and it's very cross-functional. You deal with FDA, you deal with regulatory, you deal wit the research team, etc .
If I was involved in clinical research, I would want to be a clinical research coordinator. A clinical research coordinator's job is to make sure everyone in the team is complying with all the rules and regulations. They also work with the companies to set a budget and are in charge of recruiting patients. They make sure everything is going smoothly and that trials are going as planned. I decided to pick a clinical research coordinator because I enjoy managing several projects. I also enjoy organizing and planning projects.
Guidance for Clinical Trial Sponsors: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf
I would select to be a sponsor for clinical research because they are responsible for initiating the clinical investigation, documenting the research, and submitting the IDE with Regulatory.
Sponsors are Medical/Clinical subject matter experts (SMEs) from a corporation who is innovating a new drug or device. Sponsors essentially research, prepare, manage, and document clinical research. They investigate and conduct preclinical studies to identify optimal parameters for the clinical study, such as safe dosages for human trials, identification of associated risks, or recommendations for clinical monitoring. From the preclinical trial results, the Sponsor creates the clinical trial protocol. They determine selections for locations, investigators, and create the case report form (CRF). During the clinical trial, sponsors ensure the study is conducted to comply with good clinical practices (GCPs). Once the clinical study is complete, sponsors prepare the documentation of the results and work with the company's Regulatory department for submitting the clinical data to the appropriate regulatory agencies.
I like the aspect of having the opportunity to research predicate clinical data, innovating the clinical trial protocol, managing and monitoring the clinical study, as well as being able to analyze the clinical results in either preparation for a regulatory submission or to evaluate findings to continue further research.
I would prefer to be the medical writer, they have a very important role after the research is done. Not only are there many sources of employees, like pharmaceutical companies, hospitals or government agencies. The trial is compromised of several employees and the medical writer has to get the perspective and comb through data from the whole trial. In order for the medical device can be picked up by not only hospitals but, physicians sometimes the public and medical companies. I believe reporting knowledge and convincing the public or purchaser to convey the data properly in order for the devices success and longevity.
I would prefer to be the Principal Investigator. I have worked on a variety of research projects in academia and industry, and have gained a great deal of experience. Additionally, each PI that I have worked with has indicated that I am prepared to lead my own project and I am inclined to agree. From working my experience I have found that a focused research or innovation concept; compelling background/significance; validated measures; and a qualified team/key personnel are enough to submit an idea for funding. Also, I consider myself to be an effective leader and supportive team member.
The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Principal Investigator retains ultimate oversight responsibility even when specific tasks are delegated to other site research staff. Also documenting the delegation of study responsibilities to qualified and adequately trained research staff, Supervising study performance and overseeing the performance of study staff at the research sites, Ensuring that participants well-being and safety are protected. Make sure all study procedures are conducted at the research sites in accordance with the protocol and GCP.