In response to a question I received from a brand new study coordinator the other day, I discuss free software that are available for a study coordinator, or even an entire research team, to keep their studies operating smoothly and efficiently with everyone on the same page. I also get into the reasoning behind why it is important to keep track of your information such as patient names, source docs, visit dates, contact information, etc when conducting even one clinical trial. I am curious to hear from you guys in the comments below as to how you go about keeping your studies organized.
Posts tagged study coordinator
The question I received from a clinical research manager recently was when to invoice for a particular cost associated with running a clinical research study at a site, the pharmacy fee. The individual asking the question wasn’t quite sure when to invoice this and also wanted to know if there were any other fees that she should invoice for that are commonly associated with invoice-able fees for clinical trials. In this video, I try to summarize when to invoice for certain clinical trial costs and also how to go about doing this. Please comment below with any other suggestions.
This video response to a viewer question earlier this week revolves around the topic of research study coordinators, their salaries, and how much is appropriate for a raise in a coordinator’s salary given a few specifications that I discussed in this video. Basically, this person has been a coordinator for several years, but has been with this particular company for one year and has not received a raise as of yet. If any of you have any advice for this viewer, just leave your comments below and let us know what an appropriate salary raise would be.
“What Makes The Perfect Study Coordinator?”
Let me just start by saying that nobody is perfect. We are all human, and we all have strengths and weaknesses. But there are some characteristics that make a strong study coordinator, and here are four key traits that one must possess:
Be Organized: Organization is key, so much so that I will say that if you are a very unorganized person, then clinical research probably isn’t for you. Think about what the word “coordinated” means. It means you are able to do more than one thing at once. Coordinators juggle a LOT.
You are the bridge between the sponsoring companies, the patients, your staff, your principal investigator and the Institutional Review Board (IRB)- and each one of these groups will need and want things from you, and you will need to deliver- sometimes before a deadline hits.
Most coordinators deal with several different studies in various phases and stages- another reason that you must be highly organized so you know which end is up. Have several folders (both physical and electronic) that are clearly labeled, write things down, use sticky notes, post notes on your personal bulletin board and so forth.
Communicate: A strong coordinator will communicate often and quickly. Questions will be asked by patients, sponsors will ask you for data, IRBs will ask you for documents and so forth. You should provide answers in a timely manner, and seek out the answer if you do not know it. Be accessible. Check you email and phone messages often and reply to them.You do not want anyone, especially patients- to feel ignored as this can pose a safety risk; and it is also bad customer service. Keep your staff and principal investigator in loop as far as study progress goes and alert them of any significant developments. Initiate meetings. I know that is sometimes easier said than done. I have often said that getting a group of doctors together is like herding cats- next to impossible! But give it a try. Even if you cannot meet in person, you can communicate via email, phone and even virtual meetings.
Be Flexible: In research, sometimes the unexpected happens. A patient will have a serious adverse event, a staff member will quit, a sponsor will terminate a study- all of these will have you scrambling and you may have to put other tasks aside for the time being. You must be able to “switch gears.” Be flexible with making time for your principal investigator, patients and study monitor visits. Some studies require flexibility as far as enrolling on “off hours” like evenings and weekends. Being able to travel for investigator meetings is another need for flexibility.
Be Interested: It is easier to come to a job if you find it interesting. It is not unusual at times for a job to seem routine or tiresome. So, find ways to keep an interest in your field. Attend continuing education events, read journals about research, buy a book about research, or even watch a film about research or researchers. Network with others who do what you do- either in person or online. Keep a sense of humor and a positive outlook. Think about the “big picture” – that you are part of something big, which is discovery and improving patients’ lives.
To learn more about becoming a study coordinator, check out this inexpensive DVD on this topic.
Today’s video is in response to a viewer question I received regarding tracking account receivables at a small but busy site. In the viewer’s case, she is a study coordinator who has also been assigned the task of tracking revenue at her site. While I try to offer some pointers in this post, there is no perfect solution to this problem, just whatever works and the user is comfortable with. For a detailed breakdown on this, check out an interview I did with Ana Marquez on this topic and other financial aspects of clinical trials.
Someone recently posed the question: “What do you find most exciting about clinical research?” I find that it is hard to answer this is in just a few words. If I was to sum it up, I would say, “making a difference.” The role of clinical research is an awesome responsibility when you think about it. It determines which new drugs get approved that will enhance, or perhaps even save people’s lives. I find it exciting and humbling to be part of that. It is a great thrill to work with a drug that I later see gain FDA approval- to see it go from a number to a brand name. It’s kind of like knowing an unknown actor who finally becomes a star.
Another exciting aspect about clinical research is that it is never static. It always changes. There are always new treatments to study, and improvements to be made on the treatments we already have. Just when you think you have seen the best drug in its field, another one comes along that has promise to be better. Research never stops.
I also find it exciting when I have opportunities to connect with others who work in the profession. Logistically, research coordinators are often isolated in their private practices or hospital departments where there aren’t too many other coordinators around. Meetings and conferences have given opportunity for interaction, and the rise of social media have been especially beneficial.
I keep these thoughts in mind if I find myself aggravated- and anyone who works in this field can tell you that there will be times when you want to tear your hair out! In the worst times, you have to deal the demands of the study sponsors, the requests of the IRB, unpleasant monitor visits, noncompliant patients, stressed out Principal Investigators and so forth. There is also the strain of meeting enrollment demands, as in many cases, payment amounts to center depend on the amount of subjects enrolled in a clinical trial. Often, the existence of the research staff’s jobs depend on the amount of subjects enrolled. As unpleasant a thought that might be, it is a hard truth that clinical research is also a business and a competitive one at that, so there is a sense of urgency to enroll when you can. My former principal investigator was found of saying, “We’ve got to strike while the iron is hot!” The sponsor also has the pressure of deadlines to meet- which in turn is transferred to the participating center.
But all of this is quickly fades when I think about the main benefactors to research: the patients. Things happen when patients sign up for a clinical trial and come in for their visits. You get to know their personalities, their hopes, their fears. A relationship is formed. You find yourself rooting for them, hoping that the study drug will enhance their lives. Nothing gets more exciting than telling a study patient that the drug worked and that they are cured. To witness the looks of relief, the smiles, the tears of joy- is priceless. And it reminds me why I do what I do.