Cure Talk recently had the opportunity to interview Jennifer McWatters, a Clinical Research Coordinator (CRC) at Reproductive Science Center, in San Ramon, CA. We are extremely grateful to Jennifer for taking the time out to speak to us about her life as a coordinator, the type of clinical trials she is managing, the challenges faced as part of her work and the rewards of being a clinical research coordinator. The conversation was very insightful and at the same time, it was fun to learn about a CRC’s daily life. We expect to do these interviews regularly at Cure Talk and will be speaking to several coordinators in the weeks to come.
So to begin with, let me first introduce Ms. Jennifer McWatters and her clinical research site.
Ms. Jennifer McWatters is a Clinical Research Coordinator at Reproductive Science Center in San Ramon, CA. Reproductive Science Center is a specialty infertility practice managed by Dr Donald I. Galen (who is the Principal Investigator at the site). This practice is part of a group of practices owned by IntegraMed.com (which owns a number of infertility clinics all over the united states). Almost all IntegraMed practices have clinical studies underway with most focusing on infertility (Infertility is a significant health issue and a number of clinical trials are underway to investigate existing or new treatments for Infertility). At Dr. Galen’s clinic, Jen has been coordinating clinical trials related to womens’ health issues such as uterine fibroids, sexual dysfunction, infertility and is constantly “looking to help patients and science”.
Going further back, we asked Jennifer about her background and how she came to become a CRC! As Jennifer says, “I got into it as a fluke, actually. I worked in a cardiology practice as a back office assistant in Pasadena , CA. They needed a research coordinator and i figured i would ‘learn as i go’ (a trait that is almost critical to being a successful CRC). The site was doing a number of studies in cardiac pacemakers, cardiology devices. And then i joined a site management organization… and that all started around 13 yrs ago.” So over those 13 years, it has been a lot of studies and helping lots of patients to access investigational treatments.
Now on to more details. We were curious, as to what Jennifer’s normal day looks like (and thus in some ways understand what a clinical research coordinators typical day looks like). So we got talking about her daily work. As Jen says, “I begin my day with checking emails, get on the phone, go to my voicemail. There are so many time sensitive things – doing your paperwork, responding to sponsors. You are checking with the IRB. All this has to be done in a time sensitive manner. Basically a lot of my day is on phone and computer.” She then laughs a bit and adds, “also yes, sometimes, you know patients will text me. So i have to even check my cell phone!”
In terms of actual work activities, she does a range of tasks such as scheduling patient visits, doing the study related paperwork, managing the protocol documents and binders, screening the patients, conducting the study visit and much more. In fact her typical day seems to be like those reported in research studies. As noted in a time motion study and a qualitative observational study, CRCs do 90% of the work related to the day to day management of the clinical trial and that their work day is often interrupt driven, with many activities happening simultaneously in different threads.
With all the different activities running, managing work can be a task in itself. Jennifer, says anecdotally, “I joke with my son that she is pretty sure he will have to bury me in a binder.” Pausing for a laugh, she adds “Anything i have, i put it in a binder or a file folder. Its conceptually easier to grasp the organization of it as you know there are like 500 or more page to manage per study protocol. So i break it down, break it by category – correspondence, IRB, patient information, Serious Adverse Events, etc”. Says a lot of her time is spent looking through binders, binders and more binders!!! She organizes her binders well so that she can retrieve information easily else she could easily get swarmed in thousands of pages (see image below).
So given the amount of work, and the information to manage, what strategy does she employ to get everything done and keep the work in control? She is a firm believer in doing “one thing at a time. You take it, you get it done, you move. One thing at a time.” She does “multi-task” but she usually looks at the day and see what needs to be get done now, like “do i have to do the paperwork now, if i have to see 5 patients? So you see patients one day and then do other stuff the next day.” This is something that has been echoed by many other coordinators. As reported in studies mentioned earlier, clinical research coordinators have to spend a lot of time on paper work and simple information management tasks. She also provides another tip that helps her to manage her work effectively. And that applies to scheduling patient visits. She “really looks at the protocol. Look at it and then based on the schedule of the visit, make the patient appointments”. Knowing what the protocol is, know what are the steps and having your own tools (Microsoft outlook in her case) can be very effective.
And yes, by the way, if you are wondering, how many hours does Jennifer end up working, take a guess! Jen says, she usually gets in to work by morning (meaning 7am) and could easily be in office till 5, 6 or even 7pm. She says, “As my son is getting older, i have more flexibility. But on average, i spend 8-10 hrs a day. Plus i sometimes get calls when at dinner (which being a single parent with a growing child, requires skilled juggling) or when on vacation! Patients call me. So i could be working 60 hrs. So you are always involved.” Such is the dedication and commitment required as part of the job and which we salute CRCs for.
Next our conversation moved on to her experience with administering informed consent to patients. Informed consent can be a time consuming task but it has to be done for each study and each patient. Jen says that a patient who really reads the informed consent will either have no question or a lot of questions. Jen says she could “easily be spending 45 minutes and even 1.5 hrs or more if the need be, in administering and explaining informed consent to her patients.” She has developed a heuristic that if she notices that patients have taken then less than 10 mins to go through the consent form (which are usually 10+ pages long), then she knows she will have to do more explanations to the patient. So usually “goes section by section. Looks at the side effects evaluates and re-evaluate sections”. She tries to “explain the risks as clearly and exhaustively as possible. She believe “in being upfront about everything, spelling the risk possibilities” so that patients can be confident. She is also particular about explaining general surgical risks (such as chances of embolus, anesthesia, etc). She says she is “very honest with them so that the patients don’t say ‘you didnt tell me that’.”
She continues. “When i talk to them on the phone, i could easily be on there for 20-30 mins, to really know if they are involved in the study. By the time they get to the clinic, they know what to expect, so they know what they are coming up here because they need to get help or a different way to get the treatment they cant get otherwise.” By following these simple principles she has managed to get a very good consent agreement rate. In the 13 yrs of her being a coordinator she has had only a few patients who may have not decided to sign the consent form. And usually it is so because of the problems when you have to translate, like in Armenian or Chinese.
We next discussed what she thought about the reasons why patients volunteer to be part of the clinical research studies? What motivates them? Jen explains, “It depends on the study. For example, if you are studying something with no legitimate cure, then the patients maybe do the study to help themselves and others in the future. But if there is a weight loss clinical trial, then i think people want a quick fix. Same in a cosmetic trial.”
And what do her patients think about the experience of participating in the clinical trials? She adds that a lot of her patients do have a “positive experience.” They will tell their friends, “oh my god, it was so easy,” “i did it, it was enjoyable” or “it educated it me.” Jen thinks lot of people are getting involved in them and patients always recommend her to other patients. She gets ‘thank you’ notes, hugs, appreciation cards – as she says, “its just that they are happy to get their life back.”
And in the end she says its all worth it. She get her reward from the way the trials may help patients change their lives. She remembers cases where ‘”patients with endometriosis enroll and then do a clinical trial and then go have a child.” Then there is the personal reward of ‘getting to know people, getting to educate them, giving them firm options if things are not working for them. Then you randomize them and then hearing them say ‘Jennifer, i was able to walk 5 miles without having to take medication’, or ‘if they get pregnant after they have been trying for 2 years. So that it really makes it worth it.”
She also recounts one patient who participated in an endometriosis trial two years ago. Jen says, “She hated to be touched. She had had lots of exams, pelvic exams, so much so that she just hated to be touched. She even was having problems with her spouse, as she couldn’t have intercourse. And then after she enrolled she was randomized, she took the study medication, and called back after a month saying ‘a don’t see any difference’. And then the second month, the same patient called back saying, ‘i just had a period, and OMG, i didn’t have any pain. And it was normal, then it continued on all like that’.”
Or she remembers another patient who was on the verge of hysterectomy. This patient called and canceled her hysterectomy. She came in, got treated in this uterine fibroid trial , and then they call back a month later and say, ‘Awwww i am so happy its normal (periods), great reduction in blood flow, fibroids shrunk. I am so happy.’ So that is the good times.” Jen adds wistfully that people don’t often hear the positive stories but only the negatives. This does work at times.” It is exactly such stories of hope that motivates us to continue improving on ways to enable patients to find new treatments or to discuss such stories as we did in our previous posts on Cure Heroes (Jen was one of those mentioned).
Moving on, we next talked about some of the challenges Jen faces as part of being a clinical research professional. Jen says one of the concerns has been how to get more studies. She believes, the trials have slowed down either because the “phases are slowed, or new drug pipeline has slowed down”. She adds that the FDA is strict and that they can pull drug studies for safety reason (such as reports of serious adverse events). She also expressed concerns with the timing of payments , as they usually get delayed. Plus there are some extreme cases, for instance when a company went belly up. They had to for another 6 months to get paid and that too after the company was sued!
In terms of management of work and tools she wishes, “All sponsors would use one e-CRF (electronic case report form). Everybody has their own, some of these are not so easy and so you have to learn each one of them. But if you are going to do it, be on top, then you are going to be on top of it. It is just how you get through with it. They are nice, they are easy but if they could make it standard, it would be so much better.” This is indeed a much felt need. The different e-CRF systems make it very challenging to learn each one individually.
So before we planned to wind down the interview, we touched about the topic of keeping up-to-date with the happenings in the industry in general. And this is where Jen said something that was really exciting and good to hear (definitely the first we have heard from CRCs) she uses Google Alerts to keep abreast of upcoming trials, the FDA website and changing regulations! Now that is cool because normally coordinators are known to use technology only because they have to. Beyond Google alerts, she reads journals and relies on her colleagues to know what is going on. She tells excitedly, “I Got Google alert for an infertility trial and i clicked on it took me to the trial page for her trial on TrialX!
And lastly we touched upon having fun as part of the job. She did say and (as can be readily apparent), coordinators work a lot, so it would be nice to have something fun to do. Some activity or get together. Yes there are conferences, but maybe something simpler, manageable would be interesting (this is something we hope to get going- stay tuned for more info to be post soon).
Before we ended i asked Jen, if being a clinical researcher has been personally, professionally and financially satisfying. And not surprisingly her answer was, “Yes. Yes. Yes, to all three.” Kudos to Jen, for having been a dedicated Clinical Research Coordinator and for help patients every day to get back their lives.