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Readers like Lynn Sadowski, a senior clinical research associate at Sention Inc., share their experiences.
Lynn Sadowski is a senior clinical research associate at Sention Inc., 4 Richmond Square, Providence, RI 02906, (401) 272-7177, email: firstname.lastname@example.org.
If youre a monitor, one of the most important relationships youll ever have is with the coordinators of your sites. After all, when the database is about to be locked, and you need one final data clarification form (DCF) completed and returned to you in three hours, its the coordinator to whom you beg and plead for assistance. Past experience tells you that the coordinator is your go-to player when you need something done. You want to make sure that this go-to player is on your side.
Although much of this is common sense, it seems worth repeating. In our worlds of connecting flights, DCFs, lost reservations, and visit reports, sometimes some of the finer points of relationship-building are left on the plane with the empty bag of snack mix we had for lunch.
In order to build and maintain your relationships with your coordinators, you need to use both technical and personal methods. Early on, the technical methods that you are going to use to build your relationship will be to provide training and define expectations and roles in the study. In order to maintain the relationship you will continue to use these technical methods by providing ongoing training, providing support for the site, and making sure that you wear your monitoring hat when you visit the site.
The personal methods may be a little more obvious, but nonetheless, are worth repeating. Early on, you will want to develop a personal relationship with your sites in order to break the ice. The easiest way to do this will be to get to know your coordinators outside the clinic walls. In order to maintain this relationship, you must make sure that each coordinator feels appreciated. Recognize the efforts that have been made for your study, and provide feedback both verbally and in writing.
Early in the study
During your first meetings with the coordinators, you can use the following methods to build the monitor-coordinator relationship:
Emphasize strengths, both yours and theirs. You are a regulatory guru. You are a master of the protocol at hand. The coordinators are the experts in the disease that you are working in, experts in the operation of the units that you are monitoring, and experts in the subjects enrolled at the sites. To complete the study successfully, you need to find a way to tap into both your strengths and the strengths of the coordinators.
To accomplish this goal, you need to form a team with your coordinators. And by all means, let the coordinators know what their role in this team is going to be. Ask the coordinators questions about the disease background, ask their opinion on issues, and work with them to develop resolutions to noted issues.
Nobody likes a monitor who comes to his or her site and says, Do this, and do that. Making the coordinators active participants will help them feel like a part of the team you are trying to form. Ultimately, this will lead to a more effective and more productive working environment.
Train. Take the time during the qualification and initiation visits to assess the knowledge base of the coordinators. If the coordinators dont know how to consent subjects, randomize subjects, complete source documentation, complete the case report form, and dispense the medications after the initiation visit, they arent likely to do it right when the study begins. Nobody wants to author (or monitor, for that matter!) a truckload of Notes to File detailing all the mistakes that were made that could have been prevented through training.
This is not to say that training should end at the initiation visitreeducation and training should take place at every monitoring visit. Remember, your job is to give every one of your sites the tools that they need to successfully complete an FDA audit. If you fail to do this, you have done an injustice to your study, and most importantly, to your site.
Define expectations. Nobody is a mind reader. You need to be very clear about what your expectations are, both verbally and in writing. If you expect all corrections requested at a site to be made to the case report forms before the next monitoring visit, tell the coordinator that, and write it in the follow-up letter.
Also be very clear about what the coordinators can expect from you. If you are going to assist the sites in generating Notes to File, notifying their IRB of issues, or revising regulatory documents, make sure you let the coordinators know this.
In order to work as a team, monitor and coordinator both need to know what the other person is doing. Defining your expectations of each other will ensure that all needed tasks are accomplished, and that efforts are not duplicated.
Get to know your coordinators. I am not suggesting that you spend evenings drinking margaritas with your coordinatorsyou need to maintain a professional boundary. I am suggesting that you simply make an effort to communicate with your coordinators on a personal level. Make it a point to ask your coordinators about their weekend activities or plans, or their families.
Ultimately, the more comfortable your coordinators are with you, the more likely they are to call you with a question or a problem, rather than letting it fester until you uncover it at your next visit.
During the study
After your relationship is established, you can use several methods to maintain that relationship.
Avoid coordinator isolation. No doubt you have done a great job making your coordinators feel like part of a team while you were onsite. The tricky part is making those same coordinators feel like they are not in this alone when you are in your office 2000 miles away, and your next visit is in two months.
The easiest way to prevent this coordinator isolation is simply to make yourself accessible, be it by fax, email, telephone, pager, or cell phone. Encourage the coordinators to contact you with questions or concerns, and make sure that you respond quickly to messages, emails, faxes, and so on.
If you are like many monitors, and any time not spent at site is spent in an airport, have a backup contact person available, and make sure that your coordinators know who that person is and how to contact him or her in an emergency.
The last thing you want is for coordinators to feel abandoned. Find a way to communicate with your coordinators that is convenient both for you and for them. Maintaining an open line of communication while you are not at the site will ensure that your team does not disintegrate between monitoring visits.
Wear the right hat to your monitoring visits. When you are monitoring, remember to take off your auditing hat. Your job as a monitor is to note issues onsite and to work with each coordinator to develop acceptable resolutions. Dont turn yourself into the Big Mean Monitor who tells the coordinators about issues with an implied, Youre so stupid! tacked on to the end of the statement.
Issues are going to come up. Some issues will come up that you cant resolve with a Note to File. When you are discussing issues with a coordinator, make sure that you explain them in an informative fashion, not a degrading one. Be honest, tell the coordinator how serious the issue is, and initiate an open conversation to determine the best way for your team to proceed from that point. Dont revert to a you need to do this mentality when issues are noted. This will only serve to isolate the coordinator and break up your team. If you want your coordinators to act as a team through thick and thin, make sure that you, yourself, act as a team member.
Do something nice. Do something nice for your coordinators whenever you can. Often incentives or gifts that are offered to the sites pass by the coordinators desk and land on desks of those less deserving. Try to single out your coordinators and do things solely for them whenever possible.
If your sponsor approves, take the coordinators out for lunch, bring breakfast into the site on a monitoring day, or send the coordinators chocolates or a gift certificate.
If money is an obstacle, send the coordinators a thank-you card for extra efforts made, call the coordinators to personally thank them for their hard work, or send them each an e-card to break the tension of a difficult time period in your study. This will ensure that coordinators are aware their efforts are appreciated and will encourage them to continue to make such efforts.
Thank them for their time. Personally thank coordinators for the time they spent in preparation for and during the course of your monitoring visit. Often coordinators will work long hours to prepare for a monitoring visit.
Simply acknowledge that you value the time a coordinator spent organizing the study documentation, making appointments with various study personnel, and generally remaining at your beck and call during the course of the monitoring visit. Consider how nice it would be if someone came into your office and said, I know how busy you are and how valuable your time is, and I just wanted to say that I really appreciate the time that you took to . . . .
Pat them on the back. If a coordinator is doing a great job, tell the principal investigator (PI). After all, dont you like it when someone compliments you on a job well done in front of your boss? Inform the PI during the course of the visit and also try to follow that up in the letter to the PI detailing the findings of the visit. Documenting this in the follow-up letter is nice because this ensures that the contract research organization and/or sponsor are aware of what a great job this coordinator is doing.
What if its not working? If you find that the relationship you would like to have with a coordinator is not being built, have some frank conversations with him or her to determine what is keeping you from attaining that team relationship. Often these relationships stagnate as a result of some miscommunication along the way. Once you clear up the miscommunication, you can move forward to build the strong team relationship that you need to successfully complete the study.
If you do establish a strong team relationship with your coordinators and are able to maintain this relationship throughout the course of the study, you will be blessed with sites that you enjoy going to monitor. You will find fewer errors, more resolved issues, and coordinators who are more than happy to work with you to accomplish your goals. The bad news is that when the study is over, you will likely be very sad to see those coordinators go!