What do you first think of when you hear Clinical Research Associate? The first thing that comes to mind is travel for sure. Other than that, do you really know what their day to day activities consist of, as well as, what they must balance and multitask? There are many deliverables a CRA must balance between visits while still being on-time. I definitely learned that when I would go to these places, I didn't really get to venture out as much as I thought I would LOL.
The staff at the airport would pick on me, and say that it was a waste for me to go to West Palm Beach. They would ask me if I was going to the beach, and I would answer, “No, I'm probably going to head back to the hotel room and get some work done before the next day at the site”...(It was nice when I had an ocean view though, so I at least got to enjoy a little bit of the ocean)...One day I proved it to them LOL. I went out to the beach after work, and I had to take a picture to prove that I really went. Guess what though? It was a pic of my feet, with my laptop on my lap, because there were certain deliverables I wanted to get done that day hee hee.
There is so much to balance in between visits. In order to stay on-time, it may require working while you're at the airport or in the hotel room after a visit. Being a CRA is definitely a blessing of a career, but it's not a nine to five job, that's for sure.
So we've established that a CRA travels and monitors at their assigned sites, but I want to also take a look at the other priorities…..the priorities that may conflict, and where a CRA has to get creative and innovative in order to ensure that all the deliverables are met and again, on time.
Time management is definitely an area that most CRAs can get stuck in, or struggle with, including myself earlier in my career. I've totally been there and completely understand how overwhelming it can be. So, let's start from the beginning…..
When you're assigned to a study team, you're going to have your assigned sites, and you'll visit them as per the Clinical Monitoring Plan. You're going to hear a lot about this document in your career. It's also known as a CMP, and I'll refer to it more in future blog posts, but the point that I want to make is that you're going to travel to your sites as noted per the schedule outlined in your CMP. So, in addition to traveling and monitoring, what else? What else does the CRA have a responsibility to complete and perform?
Well, you need to complete pre-visit activities which includes contacting the site to actually schedule the visit, and once confirmed, you will make travel arrangements (I'll go over tips on that in the future). In addition to scheduling the travel, you're going to complete all the tasks to prepare for that visit.
Now there's actually four visit types that a monitor will perform. The differences and purposes for each type, as well as, the tasks to be completed before, during, and after will be reviewed in detail in the January course. Since this post is dedicated to time management, I don't want to stray too far off from this topic, so I'm just going to call it visit prep as a whole for right now 😊
So, if there are activities to be performed before the visit, then after the visit, there must be follow-up, right? This consists of the famous trip reports. For those of you with a coordinator background, you may have heard this term from your CRAs. Trip reports document everything observed at the visit, what was monitored, any issues identified, resolution, any re-education performed with the site staff, if anything was escalated, who was present at the visit, and so much more. It is very detailed. Again, that's a whole other topic, but in a nutshell, the monitor is the eyes and ears at the site. The trip report should give the reviewer a clear picture of what went on at that visit, what issues were noted, and what's pending resolution.
At most companies, these reports have timelines for the draft and the final version. This deliverable is very important, so important that it's usually tracked by upper management as well. I'll touch on metrics in a bit, but in my experience, draft trip report submission was either at five business days or seven business days. It depends on whose Standard Operating Procedures (SOPs) are being followed for the study - sponsor SOPs or CRO SOPs, for example. These procedures will state the deadlines required. Again, in my experience, draft reports were either due at five or seven business days, and they were due for finalization within ten or fourteen business days. Again, this depends on the study and the SOPs in regard to the due dates. The point I want to drive home is the importance of on-time trip reports and I'll go into the ‘why’ later. The draft report is submitted, it’s tracked if on-time or not, then it is reviewed, it is sent back to the monitor for clarifications/revisions needed, sent back to the reviewer, and then finalized which is tracked for timeliness as well.
Another follow-up deliverable is your expense report. This is where all the charges for the visit are expensed. For example, airfare, rental car, cab, Uber fees, meals, hotels, things like that. So, either you or a corporate card is going to be reimbursed for all of these charges if it is compliant with your company's travel and expense policy. This will be something that you will review and train on when you start at a company.
Expense reports usually have timelines as well. In my experience, if there was airfare, this was expensed prior to the visit, and then all remaining charges (because they were incurred during the visit) had to be expensed in the system within ten days after the visit. This will depend on your company's SOPs and policies in regard to what your due date will actually be.
Other items that may be tracked and included in metrics (maybe not necessarily by upper management), is the date the follow-up letter is sent to the site, which is usually when your trip report is finalized. Also tracked, is submission of documents to the Trial Master File. This is a file maintained for the study at the CRO/sponsor level. This will be reviewed in the January course, as well as, future blog posts. I don't want to confuse you on what the TMF is, but to point out that submission of documents to the TMF is another deliverable. This is an important deliverable as files should be audit ready at all times. So, this is something that we want to ensure is on-time as well.
Another follow-up item, (and I'm trying to be as interesting as I can, as I know that time management is probably not the most interesting topic LOL!!), is submission of timesheets. You may wonder, "Okay, it's one thing if I'm hourly, but why would I complete a timesheet if I'm a salary employee"? This is a great question because I actually wondered that myself when I first started hee hee. I'm like, I’m getting a salary, right? Why am I doing a timesheet? Now, I’ve never worked on the Pharma side, but as a CRO, a Contract Research Organization, we're contracted by a pharmaceutical company or sponsor to perform one or more of a sponsor's trial related duties and functions. Because we're contracted as a CRO, we need to know how much time is actually spent on the study-related tasks in order to know how much to bill a sponsor. Once it was explained to me, I was like, "Oh, okay, I get it now".
In addition to knowing how much time is spent on the task, in order to bill a sponsor, some CRAs may be on two studies, for example, with two totally different sponsors. This timesheet would need to be really detailed, such as, what tasks were performed, how long, and for which study. It is easier to actually complete these as you go in whatever system your company uses. Because as you can see, these can be detailed and lengthy, especially if you have multiple studies and multiple tasks that you perform each week. You want to make sure to keep record and know exactly how long it is taking you to complete each task for your study. Accuracy is so important.
The study CMP should include how many hours are budgeted for the monitoring visits, travel, and things like that. Also at the beginning of your study, you may get some sort of list that states the time per task that was budgeted for your study. So it may include the amount of hours that they've budgeted for trip report completion, preparation for monitoring visits, follow-up, etc. So when a reviewer is looking at the team’s timesheets it will be evident if there are any trends….is the team as a whole taking longer on tasks that we originally budgeted for? If so, maybe the study contract will require an update. So, this is another area that timesheets prove to be helpful. It is important that timesheets are completed on-time. It’s nice to have them by End Of Business (EOB) on Friday, of course, especially as a manager, you’re like, “Yay, my team rocks, and got them in!!”.
Some companies may give until midnight on Saturday or Sunday for timesheet submission, it depends on the company, but it really is always best practice to have it completed/submitted by EOB Friday. At some companies, upper management may run reports on Mondays, and you don't want your name to show up on a delinquent list with management. This is not an impression you would want to make. I know I wouldn't. If my name is going to show up, I want it to be like, “Whew, this girl did an amazing job at that site visit”, or if there was an audit and there were no findings. That’s what I would want my name showing up for, and definitely would want to be on-time. Just put a reminder on your calendar. You can do it, you can do it!! Again, if you keep up with it during the week, then all you'll do is put Friday's time in and there you go 😊
Another item that is tracked, and very important, is training compliance. As CRAs, we always want to ensure that site staff are compliant with their training. Guess what? We are required to be compliant with training too. Usually companies have what's called a Learning Management System, also known as LMS. It depends on the company regarding which vendor or system is used.
When you start at a company, you will complete onboarding and all required training, which is usually a huge list of company-wide training. When you're assigned to a study, then you will complete study-specific training as well.
While you are working at your company if there is a new SOP, or an update to an existing SOP, it's going to be loaded into that LMS system, and will have a due date. So that's something you continually want to keep track of, like, “Ok, how many pending trainings do I have?”. There were times I would think I was caught up, and down to zero, and then would go into the LMS system, and there would be a big fat 10 with a circle around it, and I’m like, what? There's ten new SOPs? So, each week, I would look at the pending trainings, sort by the earliest due date, see what was due next, and would set a reminder prior to that day. You do not want to be late with training.
So, you've heard me mention multiple times throughout this post, to 'be on-time' and 'tracked by upper management'. You may think, “Okay, here we go. The big ‘M word’, metrics, also known as micromanagement”. You think that, right? But in actuality it really isn't. Once you know why each deliverable is so important, it kind of helps you understand why the timelines are so important.
It's not really micromanaging, it's the fact that we all have obligations to meet, and we want to show compliance. So, let's start with trip reports, for example. So why are the draft, the turnaround time, and the finalization tracked? Well, the first obligation that we have as monitors is subject safety and data integrity; therefore, it's important that the observations, the issues, the resolution, and the re-education are promptly documented. In addition, as a CRO, remember we're contracted. Included in that contract are time and budget, and submission of trip reports is one of them. So, if we're not meeting timelines that were agreed upon between the CRO and the sponsor, then we're not meeting our contractual obligations. If I were upper management, I would want to know if we're not meeting our client's needs, as well as, regulatory requirements.
Next is training compliance. Okay, first, training is huge with the FDA, so we want to make sure that we're compliant with training. Also per ICH/GCPs, it's right there, black and white, stating that monitors should be appropriately trained, should have the scientific and or clinical knowledge needed to monitor the trial adequately. So, if we're not compliant with training, then we're not abiding by these regulations. What if there was an FDA audit and they asked to see a training compliance report? Would you want your name showing up as not compliant? I definitely wouldn't!!
In regard to expense reports, it's important to have timelines for this because you don't want to incur late fees on your corporate cards. You also don't want to have your card frozen, which would affect your upcoming travel. Usually these late fees are not reimbursable for an employee anyway, and then you'll have to pay that out of pocket. So, you definitely want to have those in on-time for sure.
I already touched on the reason for on-time submission of timesheets, as at most companies, upper management will use this as a tool for budgets, and items that they need to track. We need to ensure it's available to them when they need it.
You may have heard when scheduling travel, that some companies require travel scheduled within two weeks of the visit. Because airfare (as you may know this from personal travel), as it gets closer to the time of departure, gets more expensive. So, you definitely want to schedule travel in compliance with your company’s travel and expense policy. Most of the norm that I've experienced is within about two weeks, fourteen days, of the time of departure. Some CRAs have had their heart in the right place and schedule travel a month out thinking it will save money. The only thing that's scary about doing that is visits can change, can be canceled, or postponed. If that happens, and the trip is rescheduled, then you would incur charges for difference in airfare and exchange fees. So that's why usually about fourteen days out, two weeks prior to the visit, you pretty much know it's going to happen. But again, it depends on your company policies.
So, you see from all of this, there's a lot that a CRA balances between visits and it doesn't even include things like email communications with the study team and the sites, issues to follow-up on, or routine contacts with the sites as specified in the Clinical Monitoring Plan. There's a lot to balance, but with the right plan, and as you get your groove, you will realize that you can do this!
Sometimes there's a change in priorities, or maybe a new issue comes up. You’re like, “Whoop, got to switch that around”……you may have to change things a bit, but you definitely can do it. I want to share time management tips that worked for me in the January course. Here’s a sneak peek, calendar and phone reminders were definitely my best friend, or even working at baggage claim to finish a draft report just to make sure it was on-time. Sometimes, I had to do that, but you do, what you have to do, in order to get the job done.
It's such a great feeling too, when you cross another task off the list. Again, I'm going to discuss tips to succeed in time management in the January course, but I really wanted to go ahead and dive into this because it is an area that can be a struggle for many CRAs. I remember even for me, I'll share my story….earlier in my career, I was a CRA traveling constantly. I was barely in the office and at that time (this will show how long ago it was lol), when completing expense reports, we actually had to tape our receipts on paper in order to scan them in. I needed to be in the office to do this, as it was something I couldn't do on the road or at the hotel. I was traveling so much, barely in the office, and trip reports were my priority. I got so behind on my expense reports that my card ended up being frozen. Not to mention the late fees I had to pay but thank the Lord my manager was amazing. He helped me where it didn't affect my upcoming travel, and once I caught up, my corporate card was up and running again. Hallelujah!! Although difficult at first, it ended up being a blessing. I was never late with expense reports from then on, and I was able to work out a time management plan that helped me to keep all my future deliverables within compliance.
Tips with time management will also help you with annual performance reviews as these metrics are also measured on annual reviews as well. So, back when that happened earlier in my career with expense reports, it actually affected my performance review. Even though my manager said I was a star performer and a great monitor, he couldn't give me a ‘meets expectations’ because of the expense report issue, and it killed him. He was like, “Elizabeth, you are a star performer, but on paper, I have to answer the question, based on the expense report completion”. I completely understood even though it crushed me. I was a hard worker that had gotten overwhelmed with traveling at the time. Lucky for you guys, in regard to expense reports, there are so many new systems and technologies out now. By the time I stopped monitoring, I was at a company that used a system called Concur. This system had an app where you could take pictures of the receipts and upload it to the system. You could get most of your expense report done on your phone and finish up on your computer, all while on the road. So, technology has made things easier for sure.
My story ended with a happy ending because I developed a time management plan that helped me succeed, and from then on I was on-time with deliverables and every performance review moving forward, I received either ‘meet expectations’ and even ‘exceeds expectations’ on some things. I definitely grew moving forward and I want to help you guys with best tips in succeeding in time management. Performance reviews also can affect your annual merit increase (if that's something that your company has), and can affect potential bonuses. Again, I want you to succeed; therefore, I definitely want to dive deeper into this in the upcoming course.
I've been on the other side too, and I want you to remember that when your managers are following-up on the status of something, they're helping you to make sure you stay within compliance. They are not trying to be bug-a-boos LOL. For me, I would rather have too many reminders than something falling through the cracks and not getting done. Just wanted to give you that little tip 😊
I cannot believe that I am finally through. Um, are you still there? LOL!! I know it was a lot of information, and it's not the most interesting material, but it definitely can help you for sure in your career. I really hope you guys have a great day and I will talk to you soon. If you want to stay updated, click subscribe. Until next time……