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.
It may not be easy to open a clinical research site, but it's certainly not complicated. As a matter of fact, I believe you only need to concern yourself with 3 things. What 3 things? In this video I explain, but the quick answer is:
I have seen time and time again, both personally, and in my work with clinical research sites all over the world, that a site's Principal Investigator is really what will determine a site's ultimate success or failure. Typically, and especially with new sites, PI's will ultimately leave their first site either to start their own once they figure out the business aspects, join a competitor, or retire from clinical trials altogether. Knowing this, research sites should constantly be recruiting new Investigators to join their organizations. Never get too dependent on one PI!
Principal Investigator oversight has long been a hot topic in the industry and one of particular importance to the FDA. In this video I answer a viewer question on how a CRA can communicate the importance of principal investigator oversight to the PI.
usually Principal Investigators are required to be licensed physicians when it comes to participating in clinical trials. Non physicians such as chiropractors, registered nurses, physician assistants are typically relegated to sub investigator positions. There are however, always exceptions to the rules.
One of the biggest issues that the Food and Drug Administration (FDA) has been focused on lately has been the lack of Principal Investigator (PI) oversight in the clinical trials that they manage. In this video I suggest some ways that we in the industry can improve PI oversight.
In today's video, I interview a client of my consulting company that started her own clinical research trial site at the beginning of 2016. 8 months later she is well on her way to having a profitable and sustainable business. While she has certainly faced her fair share of challenges as all startups do, she was prepared to weather the initial onslaught that comes with launching any new venture. Although there are always more challenges to face, I believe we have helped her build a solid foundation from which to grow on.
I constantly talk about how the key to study participant recruitment in clinical research lies within the private practice of the referring physicians. In this video I reemphasize this point but also urge viewers to follow up with those physicians as the referrals rarely (if ever) come automatically.
Sometimes as a clinical research site owner (or perhaps even as a CRO or a Sponsor), you will come across a scenario where you will need to partner with a specialist for a rare disease or indication. In this video I make some suggestions for how to go about doing this. My CRO has already begun to implement some of these strategies.
In the clinical research industry, experience matters. In this video I share some strategies for new Principal Investigators or study coordinators on how they can legitimately beef up the experience on their CV's.
In an ideal world, when you are presenting a potential clinical study opportunity to a Principal Investigator, one would have the protocol or at least a slide deck available. Unfortunately, this is rarely the case and use entrepreneurs have to navigate around this dilemma. In this video I describe some strategies that I have used in the past and some that may potentially work for you.
In this video i discuss different ways that physicians can get involved in clinical research. Every individual situation is unique, but the great thing about the clinical research industry is that there are many possibilities.
In this video, I answer a viewer's question on what separates an adverse event from a serious adverse event and when a Principal Investigator needs to report either in a clinical trial.
In this video I discuss how a clinical research site or any organization for that matter, should go about getting new physicians to join their companies. I also discuss the two biggest objectives that I get when personally going out to recruit doctors.
In this video, Chris Sauber and I discuss in depth strategies for how to expand your principal investigator network for your clinical research company.
Research sites should always be looking towards expanding their physician network when it comes to their clinical research business. In this video, Chris and I give 3 actionable ways any research site owner can begin doing immediately!
Many brand new research sites are struggling to find Principal Investigators for their various clinical trials. In this video I share a few ideas on what and how to present to a potential PI once you have identified a few potential candidates.
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.