New (and sometimes even experienced) clinical research sites may be anxious about their upcoming clinical trial site selection visits. CRO's and Sponsors use these visits to determine an Investigator's interest, and a site's ability, to conduct a clinical research study.
Phase 4 studies are typically easier to recruit patients for, and conduct as a clinical research site. Novice sites and Investigators may be able to pad their CV's and experience by participating in these trials. Clinicaltrials.gov is free and lists thousands of non interventional trials.
Many individuals are seeking to make a career change or perhaps obtain a role with more responsibilities and pay. I discuss some strategies that anyone in the clinical research industry can implement in their next clinical trial job interview.
A study coordinator is worth their weight in gold. How do you find a decent one under market value? I hope to provide some tips in this video!
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.
One of the largest groups of viewers surprisingly are CRA's. I often get approached by CRA's that are considering opening their own clinical trial sites. In this video I answer one CRA viewer's question on whether she should quit her current job to start a clinic or not.
Ever wondered how Contract Research Organizations select which Clinical Research Associates will be put on which clinical trial? In this video I try to demystify this CRA staffing topic and discuss how the Sponsor can also tend to influence things.
There are countless clinical research training vendors touting the importance of site training. This training is indeed important, but what they do not tell you is that the only 3 trainings you will actually need from a practical perspective (excluding hundreds of medical assessments, etc) are Good Clinical Practice, NIH Protecting Human Research Subjects, and IATA (for those who will be shipping and processing lab samples). The other good news here is that all of these are FREE to anyone with a search engine at their disposal (oh wait, that's all of us).
Through my CRA Academy, I provide students and eventually graduates with interview prep services. Clinical Research Associates are currently in high demand, especially on the West Coast, and especially in oncology. In this video I was on a live, unscripted interview. Please pay attention the questions asked of me and my comments written across the screen in addition to the recruiter's questions.
I recently received a question from a viewer who works for a research clinic that is associated to a large hospital. I give some advice on how this site director can go about getting clinical trial patient referrals from these large hospital systems that tend to not have much (if any) interest in clinical research. While these situations may be difficult, it is not impossible, and there is an opportunity for a good amount of success in many cases.
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.
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.
It is important that clinical research sites invoice regularly for any pass through costs that they incur while running a particular study. In this video I explain what some of these costs may be, and when it would be appropriate to invoice a Sponsor or a CRO.
Saleh Stevens, CEO of Continental Clinical Solutions, opened his clinic in Baltimore, MD with our help in 2014. In this interview we discuss some of the early challenges that an clinical research site would face, how he is building a Site Management Organization, what he does to attract research naive physicians and lots of other actionable clinical research business building strategies. Grab some popcorn, your favorite beverage, kick back and enjoy!
Risk Based Monitoring is more than just a buzzword. Pharmaceutical Sponsors are increasingly looking for ways to cut costs when it come to their clinical research studies and risk based monitoring is a viable option. In this video I attempt to demystify this topic and share some practical implications of risk based monitoring in clinical trials and drug development. To learn more about how this will disrupt the clinical research industry in general, read my article here.
There is no substitute for hands on experience in the clinical research industry. This is even more true when trying to get hired as a clinical research associate or a clinical research coordinator. I tell my students at TheCRAAcademy.com all the time, get your hands on experience any way you can: volunteer, intern, work part time, find an entry level job, and work your way up! There is no substitute for real world experience.
Many people are naturally attracted to the world of clinical research monitoring as a career due to the relatively high salaries. There is currently a huge demand for experienced clinical research associates, but what does one with little to no experience do? I always recommend you get started as a clinical research coordinator or clinical trial assistant, however there may be another option: recruitment companies. These organizations are paid by contract research organizations or sponsors to find qualified candidates to be hired as CRA's (monitors). In this video I discuss some of the salary arbitrage that goes on in these situations.
For those considering opening up their own clinical research sites, I walk you through what you can realistically expect during those early, formative years. Cash is king so please make sure you are conservative in your income and expense projections.
Can physicians own their own clinical research sites? Are there any regulations preventing this? In this video I answer a viewer's question on Principal Investigators and clinical trial facility ownership.
I was able to interview an individual who has worked strictly in the phase 1 category of clinical trials for the past decade. In the interview we discuss how lucrative these studies are, how a clinical research site can obtain some of these trials, and how to set up appropriate facilities. I also interviewed Monica towards the end to add some more color commentary. Thanks for watching!