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.
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Some of you may know that the Principal Investigator (PI) of any clinical trial, is responsible for the entire conduct of the study at the research clinic where the study is being conducted under their supervision. In fact, by signing the FDA 1572 Form, the PI is essentially making a promise to the FDA to conduct the study ethically and by following all Good Clinical Practice guidelines. Many private research clinics are owned by the PI or PI’s that conduct their studies at their own facilities, but many other private research clinics are not owned by PI’s. A good viewer question I received last week came from someone who owns a research clinic and is trying to find a good and fair way to compensate his PI for the studies that he is conducting. In this video, I discuss three payment options (although more certainly exist if you can get creative) that are common for research clinics in these situations. Check out the video and let me know what you think is a fair and reasonable compensation for PI’s.
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.
Today’s post is another answer to a fantastic question I received the other day from a research site director who wanted to know how many study coordinators he would need to hire if he had ten studies going on at the moment. I personally like the patients per week metric to best determine how much workload a particular study coordinator can handle, although, since every protocol is unique, every situation will also be different. This will always be a balancing act and will require your site to have a solid inflow of new studies to keep your newly hired study coordinators busy. For getting more studies, check out my inexpensive DVD on this topic. Whatever the case may be, hire slow and, when necessary, fire fast in order to maintain profitability at your research site. Let me know your thoughts!
“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.