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Clinical Trial Roles

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(@amandaally1029)
Posts: 40
Trusted Member
Topic starter
 

There are different types of roles involved in clinical research, whether you are directly working on the study or aiding in other ways to help the study carry out. If you were involved in clinical research, what role would you want and why?

If I was involved in clinical research, I'd want to have the role of a Clinical Investigator. With this role, I will be responsible for investigating the study itself, and making sure it abides to the regulations; I'd also be responsible for the subjects, and their safety. The reason why this role stood out to me is because I'd want to make sure that whatever is going on in the study is acceptable, and that no one is at risk, whether it is the participant or the research team. This is also a very important role in clinical research, in making sure everything is in order.

 
Posted : 22/10/2017 4:12 pm
(@reshamn)
Posts: 67
Trusted Member
 

I would opt for the Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes of the clinical trial to make sure that they comply with certain guidelines, known as the good clinical practice (GCP). They make sure the trial is adhering to SOP's as well since that can change over time. The reason this role appeals to me is because I like to make sure the documentation is in its correct order and following proper safety and clinical guidelines. It puts me in a critical role as the internal auditor, there is a lot of liability and accountability on you.

 
Posted : 22/10/2017 6:33 pm
(@akshayakirithy)
Posts: 65
Trusted Member
 

I would like to work as a Clinical Investigator where the causes and effets of any process would be estimated. It is a very interesting role where we could connect the trials results with the effects. Each and every details of the humans would be known and would be helpful in keen analysis of the results. This is a interesting work where it willbe like solving a puzzle which is completely technical and analytical. Also, the dealing of things in a straightforward way would helps us in the perusive analysis of the collected or resulted data.

 
Posted : 22/10/2017 6:48 pm
(@mark-abdelshahed)
Posts: 80
Trusted Member
 

If I was involved in clinical research, I’d want to have the role of a Clinical sponsor. A sponsor is a person who takes responsibility for and initiates a clinical investigation. The sponsor may be individual or a pharmaceutical company. I think this is the most important role in clinical trial, because even though he is not directly working on patients, he is the one that is essentially responsible for all operational aspects of the clinical trials he sponsors, so if everything he does goes right the research should run smoothly. The sponsor develops and prepares clinical protocol, case report form (CRF), and investigator's brochures. He selects investigators, submits IDE with help from regulatory, and selects monitors for trials.

 
Posted : 23/10/2017 1:00 pm
(@merzkrashed)
Posts: 123
Estimable Member
 

For me, CRO, because CRO is like the “middle man” between the Sponsor and the research sites.
CRO get hired by sponsor, I’d say about 90% of Sponsors use CROs because the Sponsor’s specialty is creating the drug and developing new products as well as better treatments. Their expertise is not necessarily in managing clinical trials and submitting studies to the FDA for review. That’s where a CRO comes in. A CRO helps the Sponsor write the protocol, submit the data to the FDA, and monitor the sites throughout the study. Usually if the Sponsor has a CRO they will have the CRO handle all communication with the sites. They will occasionally get involved, but usually they let the CRO do that.The CROs also hire their own CRAs (clinical research associates) who go out and monitor the sites. Typically a lot of biotechs have been using CROs recently because they don’t have much expertise in managing studies or submitting studies to the FDA for review. As such, they need the expertise and the help of a CRO to hopefully bring their product to market.

 
Posted : 23/10/2017 9:07 pm
(@ppp23)
Posts: 43
Eminent Member
 

I would like to Sponsor a clinical research. The reasons are as follows:

1. Selecting a clinical investigator
2. Monitoring the research
3. Ensuring clinical trial is being conducted as per the protocol and regulations
4. Making sure that investigators are informed about the possible outcomes of the research. (any adverse effects of drugs or risks involved in a device)

 
Posted : 24/10/2017 2:54 pm
(@alexandrabuga)
Posts: 149
Estimable Member
 

If it was a sponsored clinical trial, I would be the sponsor as @ppp23 and @mark mentions, the sponsor selects the PI, prepares and submits clinical trial application and amendments to the appropriate regulatory agencies and ensures that the clinical study is conducted in accordance with Good Clinical Practices (GCP). I think its exciting to have the device/drug and create the protocol that will be tested. I think I would want to be sponsor of some cutting edge medical device like a robotic device or something incorporating the use of AI.

 
Posted : 24/10/2017 3:59 pm
(@ao242)
Posts: 43
Eminent Member
 

I will like to play the role of a Biostatician. To be able to involve in clinical research trial design, protocol development, data management, monitoring for safety and efficacy, data analysis and observational studies reporting.

 
Posted : 24/10/2017 7:40 pm
(@asimbana)
Posts: 61
Trusted Member
 

I would choose to work as a Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes clinical trial data and ensuring the testing follows proper guidelines as stated by good clinical practice (GCP). This role attracts my attention because i like to ensure that the documentation is processed correctly and that the well being of both the patient along with the tester is ensured. This role is that of a auditor for the overall clinical trial.

 
Posted : 25/10/2017 7:01 am
(@anhtong)
Posts: 38
Eminent Member
 

I would opt for the role of a Clinical Research Associate (CRA) if I were to take part in a clinical research. With this role, I would be responsible for running clinical trials so as to test the effectiveness, benefits, and risks of drugs in an effort to ensure that they are safe and can go on the market. Basically, I will be involved in all the stages of a clinical trial, executing roles such as identifying and setting up an investigational site, planning, monitoring, and even closing down the trial. The main reason why opted for this role is that I will be directly involved in ensuring that the drugs entering the market are absolutely safe. There have been some cases of unsafe drugs getting into the market, and taking up this role of a Clinical Research Associate (CRA) would mean that I would address this issue.

 
Posted : 27/10/2017 6:17 am
(@srg36)
Posts: 117
Estimable Member
 

I think I would like working for the sponsor that actually plans out the clinical trial. As an engineer, this role would fit me the best, because it would be my role to come up with the clinical protocol, and essentially plan various aspects of the clinical trial. There is a lot of responsibility associated with this role, because clinical trials cost a lot of money so it is important that a lot of thought and planning goes into it to ensure that valuable results will be obtained from the study.

 
Posted : 27/10/2017 8:35 am
 aaq2
(@aaq2)
Posts: 38
Eminent Member
 

Being a research coordinator would be my role of interest. This position requires that the study data is accurately captured and reported. The role also involves reporting any study or participant issues, maintaining regulatory files at the study site and working with quality assurance monitor and data management staff to identify and resolve data and reporting issues. The role also requires frequent interaction with study participants by performing assessments and protocol procedures.

 
Posted : 27/10/2017 2:31 pm
(@gingeranderson)
Posts: 78
Trusted Member
 

I would be a clinical project manager. I am good at looking at the big picture and the main goal of the project but also break that down into small pieces and organize and motivate people. I learned this while managing projects for the government while working for the defense contractor General Dynamics Electric Boat. As I stated in another post, I am not very impressed with some of the outputs from some particular clinical trials (please see publications such as “Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials”). I am upset because when a drug fails Phase III clinical trials and millions of dollars are lost, the people suffer the most. Not a company but actual people who have no hope. Even one mismanaged clinical trial is hope and time lost for someone. I take it very seriously and when I read that a clinical trial wasn’t managed right or pointed in the correct direction when the information was available, I am upset and want to be part of the solution.

 
Posted : 27/10/2017 4:41 pm
 ec52
(@ec52)
Posts: 72
Trusted Member
 

If I was involved in a clinical trial I would like to support the study as clinical investigator. As others fellow students alluded to the clinical investigator's primary responsibility is to ensure the research expectations are met including regulatory requirements and guidelines for Good Clinical Practices. This role stood out to me as it contributes to generalizable knowledge advancement while protecting the rights and welfare of human participants. Also, I would to add that all roles are important, but perhaps the participant's role are mostly important (healthy volunteers or participants with an illness or disease) that despite potential risks choose to engage in a study to help others and contribute to moving science forward.

 
Posted : 28/10/2017 8:26 am
(@dbonanno1)
Posts: 36
Eminent Member
 

If I was involved in clinical research trials I would like to be a monitor. I would enjoy being able to monitor the clinical trial participants heath throughout the study, and see what the effects are of taking or not taking the medication (treatment, etc,). I am very analytical in nature and being able to gather all of the patient’s health data would be interesting to me. I would also enjoy taking that data (information) to the next step and performing all of the data/statistical analysis and truly understand the effects of the clinical trial study for each of the participants.

 
Posted : 28/10/2017 11:47 am
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