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Monday, February 21, 2011

Motivating your Study Coordinators

As monitors, we rely on the Study Coordinators (SC) to assist us in site management activities like record-keeping and re-supply.  We ask them to keep us informed of progress at the study site through reporting, screening/enrollment logs, issue identification, etc.  We have them prepare the CRFs, complete data-entry, attend trainings, review newsletters/correspondence/memos, answer emails, fax in documents, and answer queries.  On top of everything else, we insist that they organize and prepare for our monitoring visits.  During the monitoring visits, we request that they are available to resolve any issues that are identified or to complete additional training.  This ongoing administrative burden during study conduct is all in addition to the primary requirements that they assist the Principal Investigator in executing the study according to the protocol and monitor the safety of all study participants.

In short, we ask a lot.  Many coordinators have several studies competing for their time and attention and one of the most important skills for a CRA is to motivate the SC to focus and respond to the demands of the trial at hand.  For the most part, my coordinators are prepared for my visits; I owe that to a mix of luck, experience, and the following techniques:

Establish and Maintain Rapport - Whether you meet your coordinator for the first time at an Investigator's Meeting or a pre-study or initiation visit, every interaction is a chance to build the relationship.  Answer your voicemails and emails promptly and invite your coordinators to reach out to you with their concerns. If you can listen and empathize, your coordinator will trust you more and keep you informed if they are falling behind.  If your coordinator feels respected and valued they will put in the time to get the work done properly.

Communicate the Timelines and Study Status - Share the study progress through regular site contacts or a newsletter and ensure that study staff know the timelines and overall picture of the trial.  Review site performance regularly and let coordinators and investigators know how they are doing compared to other sites.  You can set goals and make comparisons in terms of recruitment, enrollment, data entry/query resolution, and monitoring completion; sites find this extremely motivating if you can deliver the message and metrics in a non-confrontational way.  SCs are juggling so many competing priorities that they may not be working on something you need just because they don't realize it is "on fire" at the moment, that is way regular site contact and effective communication is so important.

Recognize Good Performance - When your site completes a required task or important milestone let them know you appreciate this and thank them for their contributions. I am constantly complimenting my sites; they are not perfect but they do lots of things well and I think they deserve that recognition.  I produce a monthly newsletter and I try to include a regular "Site Profile" section where I introduce the site, highlight their study accomplishments, and discuss their tips for success. It is a bit corny but my sites are always flattered and this seems to produce great results.
Don't be afraid to submit to bribery.
Understand and adhere to your company's
policy on gifts. Typically a non-material
small appropriate token such as a box of
donuts or pastries will do a lot to "butter-up"
and endear you to your coordinator
without the risk of appearing coercive.

Partner with your Coordinator - Convince your coordinator that you are a team and that you want them to be successful, "I know you have a lot on your plate, so let's get through this so I can get out of your hair."  Ask your coordinator, "What are the obstacles preventing you from getting your work done? Would you find it helpful if the sponsor, the Project Leader, or I spoke to the PI?"

Break out the Big Guns - All of the techniques I mentioned above will keep your study sites on track and foster a productive and collaborative working relationship.  At the end of the day however, if the work just isn't getting done you may explore alternative less positive methods of motivation.  Expose the deficiencies to the Principal Investigator or withhold site payments pending completion of the work.

Above All, Be Patient - See a related post where I discuss how issues outside of work can sometimes distract coordinators: What is up with this coordinator?

Please comment to let me know if there are other tips or techniques I should highlight in regards to motivating study coordinators.

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Thursday, February 17, 2011

Little Wrap Dress

One of my co-workers commented
the other day that I really own a
lot of dresses.  OK, that is true but
it hasn't stopped me from adding
this little beauty to my birthday wishlist!
My go-to garment in my work wardrobe is the wrap dress (recommended only for the ladies, sorry guys!).  The wrap dress is perfect for travel because it is easy to accessorize (scarf or long beaded necklaces or chains) takes up next to no space in my suitcase (read here about what I pack for a monitoring trip) and looks professional when paired with a cardigan sweater, pashmina, or blazer.  Also, I pay attention to fabrics and always go for a dress that is wrinkle resistant so I don't waste time ironing or money cleaning (think polyester, spandex, matte jersey, etc. - not totally luxurious but ideal for balling up in a suitcase and typically machine washable or can be hand-washed rather than going to the dry cleaner).  Spring is coming and these don't take up much room in my closet either so I can usually sneak in a new one every now and then without my fiancĂ©e noticing. ;)

I do like to pack a wrap dress for multi-day trips but I typically save it for day 2 or the midpoint of the visit. I make other choices on travel days because a dress is really not ideal for going through airport security; I don't want to take off my shoes and walk around barefoot there and I am a bit more restricted and limited in reaching or bending.  Gee and I would not be thrilled to receive a secondary pat-down/feel-up in one of my beloved wrap dresses (I refuse to go through back scanner x-ray machines).  Also, I might get a little cold on the airplane so I prefer long sleeves and slacks.  Other than that, I really feel this is must-have smart attire for all the young female monitors since it is forgiving enough to flatter most body types.  Ladies (again, sorry Gents, this post is just not for you), if you haven't rotated one of these pieces into your wardrobe I recommend you give it a try.

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Wednesday, February 2, 2011

Lead CRA Q&A: What makes a good CTA?

Anonymous said...
I want to be the best CTA possible, with the opportunity to become a CRA. As a Lead CRA, what qualities do you look for in a CTA? APRIL 12, 2010 2:38 PM

NadiaBoBadia responds...

Thanks for another great question.  You know what the problem is with all of my favorite Clinical Trial Assistants (CTAs for short)?  They are so awesome at their jobs that they get promoted and then I need to start over with a new CTA. :)  In all seriousness, I have a pretty standard approach to evaluating candidates for the CTA role.  Among the things I look for are relevant experience, strong organizational skills, great written and verbal communication, ability to multi-task and focus/produce, flexibility, eagerness to accept all tasks gracefully (no matter how boring), and desire to learn.

That is a big laundry list and I haven't necessarily ranked things in order for priority so I will discuss a few of the items in more detail.

Relevant Experience: Certainly, there is some amount of training required for this role but I am looking for candidates with the correct emotional maturity and enough professional experience to operate in a dynamic, fast-paced, and stressful environment.  I don' want to hire someone who will be preoccupied with facebook or text messaging. I need someone who can buckle down and do the work without becoming distracted.  The role is a good opportunity for a worker bee who can innovate as needed to get the job done.

Flexibility/gracefullness: A CTA has to be flexible.  The needs of the Clinical Operations group tend to change on a moment's notice, several times a day, actually.  So when we get to work I may say to my CTA, "please prepare 40 FedEx labels and package up these lab supplies that need to go to the sites.  Report in mid-day to let me know how you are progressing with this task." Then at 10am I may get an urgent request from an Executive to run an ad hoc report and I will need to re-focus my CTA to help me with the request.  Is the original task no longer important? Not necessarily, the FedEx drop will still occur at 4:00pm but this new special request will force us to shift our priorities.  I really do not want a CTA who will be grumpy about this because, guess what, I'm not thrilled either but that is the nature of our job.

An ideal CTA is interested in the role and
engaged in the work they are doing.
Desire to Learn:  Administrative work like taking meeting minutes, producing binders, preparing shipments, and filing/scanning Trial Master documents (all pretty routine CTA responsibilities) are a bit dull but made easier when you can understand their importance to the team and the conduct of the clinical trials.

The nature of the work is pretty administrative so the best CTA candidates are efficient, reliable, eager to please, pleasant to work with, and extremely task-oriented.

Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.

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