If you are an employee for any clinical research company, this podcast interview with Darshan Kulkarni should be of interest to you. Make sure that you completely understand your rights as an employee, and some of the ways to better protect yourself from possible pitfalls during your clinical research career.
There are so many opportunities in the clinical research industry. At the site level, some are study coordinator, principal investigator, sub investigator, research assistant. At the CRO level there are CRA's, CTA's, CMA's, medical monitors, project managers. At Sponsor level there are dozens of others. What is good about many of these, is one's ability to "level up" over time into more desireable and higher paying positions.
If you are a physician or entrepreneur opening up your own clinical research site it is important to understand that you will need a decent study coordinator to run the entire study or studies that you will obtain. This is a full time position and a completely seperate career from the typical medical staff positions you might be accustomed to.
If you have just been hired as a study coordinator, this video walks you through what you are most likely to expect during your first couple of weeks. You will feel overwhelmed in most cases, but things eventually do tend to even out over time.
In this video I discuss why I believe the best clinical research site owners are study coordinators themselves. While there is certainly a lot more to running a business than just being a study coordinator, having the technical expertise required to effectively execute a clinical study is something that cannot be learned overnight, and is not necessarily cheap to outsource.
2017 is looking to be a promising year for those of us research site owners in the clinical research industry. For established sites, the problem won't necessarily be getting more studies, the main issue will be motivating your clinical research coordinators to enroll subjects, enter data, answer queries, and all of the other millions of responsibilities that generally fall into a study coordinator's lap. In this video I discuss real and actionable strategies for motivating your study coordinators.
So many viewers want to get started in the clinical research industry either as study coordinators or as clinical research associates (CRA's). The problem is that most of these positions will not consider the candidate unless they have some prior clinical research experience to show on their resume. In this video I discuss several actionable strategies for how to go about doing this. Also, my CRA Academy trains candidates and provides them with experience through our internship program. Hope you can find some value here.
Ever wondered what a database lock entails? Furthermore, are you like some of my CRA Academy students where you would like to get an actual clinical research study coordinator's perspective on what a database lock entails? If so, then you've come to the right blog post. I hope this video will help you better understand clinical trial database locks and what they entail.
In this video I go off on a semi rant, but one that I feel is necessary in many cases. If you are going to own your own clinical research site, there will be many challenging situations that will arise. It will always be easier to find reasons why you shouldn't do something, however, as an entrepreneur, it is your duty to yourself, your employees, and your patients to try to find solutions rather than emphasizing the problems at hand.
During the course of teaching at my CRA Academy, I realized that many people who are not as familiar with the clinical research industry were getting confused about drug accountability when it comes to clinical trials. In this video, I break down the most important aspects of clinical trial investigational product drug accountability.
This is some very simple but practical advice for my research sites out there: do not put your contract and budgets in the regulatory binder. Instead provide a note to file that explains where these documents will be kept.
It's actually not that difficult. If you have a brand new clinical research site, finding an experienced clinical research study coordinator is probably your best option. This is especially the case if you, the site owner, does not have any experience. Often times, experienced study coordinators may feel under appreciated at their current place of employment, or perhaps it is a clinic that rewards their good work with more work. Whatever the case may be, you can usually find a good study coordinator without much effort. In this video I describe some strategies.
In the clinical research industry, it is quite easy to get lost in the details of what we are actually doing. For new entrants into the field, I have already created a 2 hour crash course of what clinical research entails, however I realize many of you are still having a hard time understanding the bigger picture in this line of work. In this interview I conducted with a brand new student who has enrolled in my CRA Academy, I answer some of his questions and give him a general overview of the entire clinical research industry including many of the key moving parts. I hope this will be able to help many others out there!
One of the most frequent questions I receive from my startup clinical research clients involve Investigator Meetings. What occurs at these Investigator Meetings? Are they mandatory to attend? Who typically goes?, etc. Hope this video can help some others out there who are asking these same questions.
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Click on the links below for the basic equipment/supplies you will need (Please note I am an Amazon affiliate and earn a small commission from each purchase but these are the equipment my sites use):
Today’s question comes from someone who wants to open a research clinic. They’re a doctor, and they have a lot of patients in their private practice. They became interested in clinical research because they were added on as a sub-investigator for a trial and since then they became intrigued with research. They started talking to the PI about it, and the PI let them know that it is really lucrative — which it can be if it’s run and managed the right way. So this doctor wants to start his own clinic, and he’s asking me what the bare minimum requirements and time commitments are for having a regular, basic clinic. So when I talk about having a regular, basic clinic, I’m talking about having enough space, staff, and capabilities to conduct in your first year anywhere from 5–10 clinical trials. You can always grow after that point and open up another clinic or maybe expand your existing clinic if space permits. You could also move; I know a lot of clinics that started off really small and then they moved to bigger facilities as they grew. I’ve also seen sites that started off small and then because they got more demand and more studies but could not physically move their site, they opened up another clinic somewhere else in their city where they would conduct certain types of clinical trials. They would run 2 sites with 2 different PIs. There are a lot of different ways to do this. To meet the bare minimum requirements, you will need an office with at least 3 rooms that can be dedicated to just research. Chances are you already have an exam room, which you can share between your research clinic and your private practice. However, if you happen to have a very busy private practice then you might want to have a second exam room. Of the 3 other rooms that you need, you are most likely already using one of the three as the PI so you really only need 2 other rooms. You really need a room for the coordinators and a room for the monitors when they come in. You probably don’t want to have the monitors share a room with the study coordinators because then they can go looking at things laying out on the desk. Most coordinators will clean up at the end of the day, but during the day — especially at a busy clinic — it could be messy and you don’t want a CRA seeing that along with other protocols because then they will assume that other CRAs are seeing their protocol and the sponsor could make an issue of this. So have a separate room for monitors and a separate room for coordinators. You’re going to need a place to store your IP, but I didn’t include an IP room as an additional room you need to have because at the bare minimum you could have an IP cabinet that would be double locked and temperature controlled in either the study coordinator room or in your room as the PI. The best thing to do would be to have a separate room dedicated to just IP and have limited access to it. One of the issues with having the IP cabinet in the coordinator room or the PI room is if patients are going there, the sponsor or FDA will ask in an audit how you are preventing patients from going into the IP cabinet when you are not in the room. So having a separate IP room that has zero foot traffic going through it except for people who belong there would be ideal but not mandatory. You will need a centrifuge and a refrigerator for IP and specimen that need to be kept refrigerated. You will also need a fax machine and internet. ECG machines are usually provided by the sponsor, but increasingly I see that they are starting to request that sites have their own. And that’s about it. People usually underestimate the amount of physical space that one protocol can take up as far as all the source documents and regulatory documents go. So you need to be careful not to underestimate how much space you will need. You’ll also need a waiver to let you process and draw blood and you’ll need a lab room where you can process the labs and ship them out. As far as time commitments go, if you as the PI delegate properly to coordinators, you don’t need that much time. You can dedicate about 50% of your time to doing clinical stuff and 50% percent for your private practice. You can probably push that to 80% for your private practice and 20% for clinical research. There will be a lot of overlap especially since you are in the same office where the research is being conducted. So if the monitor is there and you’re there at your private practice you can see them. So for the bare minimum, that’s what you’ll need to get started.
I have received many questions in the past from viewers, partners and even clients in regards to what a research clinic needs to have in place for a site selection visit. These are the bare minimum requirements but I hope this video will be helpful to some of you who are anxious about your first site selection visits.
There is not too much to explain in this text, the video and image pretty much sum it up. There are way too many acronyms in clinical research and there is no wonder why there is so much confusion. Needless to say, it could become quite overwhelming for new entrants in the industry.
The vast opportunities that exist within the clinical research industry are rarely discussed outside of people who are already working in this field. When you take a look at just a research site, let alone a CRO or a pharmaceutical sponsor, one can begin to see the seemingly limitless possibilities that are available. In this video I decided to delve deeper into this topic in hopes of shining some much needed light in this direction.