The Coordinator and PI relationship: Get to Know it.

I am very excited to bring you this next article describing how you can interact with your PIs more efficiently! Many Coordinator friends have stated that they would like to hear some perspective on how to accomplish a growing relationship without feeling like they are bothering their PIs.

As you know, our friends at TrialJoin have comprised a team of many former Investigators and Coordinators and these folks gave a step forward to give you a better understanding from each viewpoint. They’ve also interviewed some of the Coordinators and Investigators that we work with throughout the country. What we found was stunning!

We realized that there were frustrations from each person that led to a lack of communication, which ultimately hinders patient enrollment. We hope that you have been finding our articles interesting so far, and hope that this is a highly influential one for your site.

Here you will find some findings from interviewing former Coordinators. After that we will dive into what we found with our Investigators — you will be shocked!

Coordinator Perspective

Each morning, the Coordinator will come in and get organized for the day. Often times there are missing signatures from the day before or there is a little bit of work left to finish the previous day. It always seems like an emergency in this fast-paced environment, but our Coordinators have found ways to deal with these things that I think you will find useful for your own site.

Check your schedule for the day:

Before getting the day started, most of our Coordinators would check their schedule for the day and ensure that they are on track to finish up all the various requirements. We all know that Sponsors have been requiring more and more information for each study and these can take away from the ability to multi-task. To combat this, our Coordinators suggest that you spend a good amount of time getting the schedule on track before starting any of your work. This will ease your mind and allow you to stay in control throughout the day. Also, this will allow you to figure out when to meet with your PI. Make sure you are not meeting with them randomly throughout the day when they have their mind on a dozen other things. This will only make them used to get ambushed and they do not prefer that.

Embed time for finishing up work from the day before:

If you know that you have some outstanding work from the day before, make sure to try and get in a bit early so you can tackle it. Otherwise, it will hang over your head the entire day. For example, if you have to fill out information from a patient visit or you forgot to wrap up a contract negotiation, try to finish this as early as possible. Once these types of things get out of hand, you will continue to stress about this throughout the day and meeting with your PI under these conditions will show that you are unorganized and unreliable. We want you to make sure that you present yourself in such a manner where you look like you are fully capable of carrying out the trial.

Customer Service with your patient AND PI:

What we found interesting was that all of our Coordinators agreed that participating in research is like being a customer service representative. Surprisingly, our Coordinators also stated that working with each of their PIs/Sub-Is also felt like being in customer service. Ensuring that your PI is happy is a big deal, and can really affect the outcome of the study itself. If you don’t have the right relationship, you can literally expect to have a lower patient randomization and most likely, a lower retention rate as well. This will ultimately reflect poorly on your site and Sponsors may not give you another chance with other studies.

Setting aside time for your PI/Sub-I:

Our highly effective Coordinators state that if you carve out time each day to meet with your PI/Sub-I, you can come off as more organized and you won’t spend time looking for the papers that you need signatures on. You will also be more organized when that time of day comes because you know that it will be coming. You will be surprised at how many PIs/Sub-Is are willing to schedule something like this — they ultimately care about the research that they are doing and want to make sure they have time for it, but they also don’t want to be bombarded by it all the time.

Meeting the PI/Sub-I:

Make sure to use sticky notes to quickly find pages that require signatures. Bring a pen with you and a hard surface where they can quickly review the information and sign where necessary. You want to be sure you minimize the time you spend on looking for the pages and instead, focus on providing high-level summaries for what you are looking for. Be consistent!!! Our Coordinators stress that consistency is the key to the relationship between the PI and Coordinator. If they constantly see you as someone in charge of the study, they can come to you as an expert and a teammate. Our Coordinators that were successful in that environment had amazing relationships with their PIs and were able to give them advice on protocols and so forth.

Starting a new study with the PI:

Set the ground rules with them early and let them know what their expectations are. It’s likely that if you are conducting the trial, the PI was interested in the study itself. Make sure to use that energy to really get them involved from the beginning. This is the best time to get them to buy into the trial. During study initiation visits, get them to meet with the CRAs/Monitors and get that relationship going. Also, spend some time to educate your PI on the protocol itself. Don’t do what most people are guilty of and spend time on the stuff they don’t need to know. Instead, go over the relevant information about what the drug does, how many patients you are looking to recruit, and relevant information about the inclusion/exclusion criteria. I cannot stress enough about how Investigators don’t want to hear about all 83 exclusion criteria, for example. Make sure you are an expert and bring them the relevant ones only. Most importantly, make sure you are getting them excited about WHY this trial is important. Tell them that this is the trial that will change people’s lives, or will offer a treatment that these patients never had a chance to get before. This will immediately get your Investigators excited and will get them to have ownership of the trial. Every Investigator wants to be on the cutting edge of research, and now you are providing an outlet for this. Be proud of the work you are doing!!!

So, we got some great tips from our Coordinators and we think that they will come in really handy for you. Now, I wanted to summarize the findings from our Investigators who said gave us some interesting insights.

Investigator Perspective

“I don’t want to be overloaded with information throughout the day!”

This was the number one request that we heard from our Investigators. Let’s face the fact that they have quite busy days between seeing patients and working with insurance companies sometimes. Not to mention, most of our PIs who are physicians are meeting with pharmaceutical reps that take up so much time. If you can somehow use the tips that we got from our Coordinators, then I think you will have a better relationship with your PI.

Bring a list of things that they want from me at once:

This is what we talked about before when we went over the Coordinator perspective. PIs don’t want to be bombarded throughout the day with information that they need to sign or information that can wait until later in the day. Instead, they would prefer that everything is done at once unless of course there is some emergency.

“The Coordinator spends more time with the patient and sometimes I want to hear how the patient is doing in a summarized format”:

This was an interesting comment made from one of our former Investigators. Although they didn’t always have time throughout the day, they still wanted to know how their study patients were doing. It was rewarding for them to hear when a patient who used to have really bad OA or gout is now doing much better. This gets them exciting and they will always have a memory in their head when seeing these types of patients. In fact, having the physician give their personal recommendation to a patient to participate in a clinical trial immediately increases the likelihood that patient will join. This is a very easy thing for all of the Coordinators to do and it takes very little time. Make sure to keep the dialogue of success open with your PI.

Frequently update them on enrollment goals and how other sites are doing:

Often times, Investigators want to get motivated when they know they are behind of far ahead. If you find out from your CRA that your site is behind, make sure to tell your PI so they can start to invite patients more frequently. This will also help the study stay top of mind. Often times, what motivates an Investigator is knowing when they are far ahead of other sites too. This lets them know they are doing a great job and they could potentially be the leading site in the nation/multination. If they already worked this hard, then they want to be considered for such a nice accolade, especially when they are meeting with their friends during another Investigator Meeting. Bragging rights are always fun and can increase your productivity by a lot. And make sure to let them know when a patient randomizes or if the Sponsor congratulates your site on anything in particular.

Providing them with little reminders about the inclusion/exclusion criteria:

We heard this request from our Investigators quite a bit. We learned that they quickly forget the key inclusion/exclusion criteria very frequently. This is to be expected and we cannot take this for granted. Imagine the day of a physician who is also a PI. They are extremely busy and can’t think to recruit a patient for a study when they are meeting patients or writing prescriptions or even conducting procedures. The last thing they remember is that this patient might be eligible for a study. So, make sure that you are on top of them and give them frequent reminders about what the inclusion/exclusion criteria is for a given study. One of our Coordinators stated that a good way to do this is to provide them with a laminated cheat sheet with the RELEVANT inclusion/exclusion criteria for each study. They will surprisingly keep this in their pocket throughout the day, and if they see a patient who might meet the criteria, they can quickly access it and determine if they should send you the patient for further vetting. Make multiple copies because they will be sure to lose these!!

I’ve certainly enjoyed this perspective of such a complex relationship, hopefully you did too! remember that this article is made in conjunction with our friends from TrialJoin, I recommend you to visit them at http://join.study/patients-from-hospitals

Zaddy Alejandro Contreras Ballesteros

Written by

Internal Medicine Specialist. I believe in Alternative Technologies in Healthcare. Clinical Research Enthusiast.

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