Good Clinical Practices within Job Roles
On any job search engine, search GCP. Select and define a role here. What are some of the benefits of GCP involved with the job role you selected? Does the job also include clinical research in the description?
When searching GCP on any job search engine, data engineering relating to “Google Cloud Platform”. However, when i type in key words relating to research with GCP, multiple jobs pop up. One of the roles that popped up is a Clinical Trials Manager. The manager is responsible for directing the process of clinical trials as well as reviewing the results of the procedure. He/she also ensures the compliance with GCP and applicable regulations through documentation and auditing. The job description includes GCP and clinical research. GCP is important in this role because it is the basis of the manager’s job. It is something that the manager can refer to and has to abide by when monitoring, auditing, recording, analyzing, and designing the trial. It also serves to protect and preserve human rights. It ensures that the trial and everything relating to it stays within certain standards.
One of the roles that came up when I searched for “Good Clinical Practices” on a job search engine was Clinical Research Coordinator. I thought this role would be interesting to discuss because I used to be a research coordinator in my lab, which required recruiting and scheduling several participants for a study. I know that good clinical practices are essential in completing the tasks that come with this job. The task description for this job indicates that whoever gets it will assist with the initiation and activation of the study, preparing study documents, patient registration, coordinating, and data entry (e.g. patient history). The Clinical Research Coordinator will also serve as a liaison to ensure that the study complies with FDA, NIH, GCP (and many more) guidelines and that protocol follows IRB approval. Good clinical practices are essential in this role because a Clinical Research Coordinator is one of the first people that a participant will come into contact with and they must ensure that the rest of the study follows appropriate guidelines. The job description mentions that as a required skill, applicants must have at least 2 years of experience in clinical research (preferably as a research coordinator).
I think one of the most common careers where GCP is involved is "Clinical Research Associate". I think this has come to mean in general, someone who is part of a clinical research team that assists with a clinical trial. Even for a general team member, GCP becomes an important part of your career as this is the standard that everyone must adhere to when conducting clinical trials. I believe any job having to do with clinical research is going to require some knowledge of GCP. For this particular role that I found on Google, the descriptions says that the associate must conduct site management/monitoring activities that are in compliance with IH-GCP regulations.
Clinical Research Study Manager was the job title that appeared when looking up Good Clinical Practices for me. The most common word I see in the job description is "lead" or "oversee and execute" showing the overall direction of being in charge of a multitude of different clinical research endeavors that will need to be monitored. Things that need to be monitored are good documentation practices as well as different consent forms and obviously SOPs (standard operating procedures) that are relevant to the task at hand. An interesting "benefit" I noticed for this role is that it would be fully remote. Is this a good way of being a "manager" of an operation that involves physically having patients involved in medicine? I'm sure it is much more convenient for the user, but I would argue that a job like this would have to be in-person at least some of the time to have a better grasp of the GCP within the work place. Documents and papers can say one thing, but the area one is involved in can say another.