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Relationship sustainability—It’s the bigger picture

Monday, November 20, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

In clinical research, we are taught to always move forward—through change to a better process, through error toward the true lesson. Our industry is constantly evolving: risk-based monitoring, ClinicalTrials.gov, social media for patient recruitment. Progress has made us so efficient with accomplishing the short-term goals (interim analysis deadlines and query resolutions) that it can take our sight off of the bigger picture tasks that, though more time-intensive, have a longer-lasting impact. Relationship development is one of these. 

The relationships we form in this industry sustain, teach and re-connect us in the most fortuitous ways. The first therapeutic area in which I was fully vested as a monitor was oncology.  During the course of my assignment to a large oncology study, I was partnered with some outstanding investigative sites. Though I received top-notch study training, I honed my oncology monitoring skills working alongside the study coordinators. 

The oncology nurse who most strongly impacted my technical skills also expanded my narrow view of the importance of site relations. She was the sole coordinator for a single physician oncology practice in a small Montana town. Despite her workload, she was very capable and very friendly. She always engaged in small talk at the start of each visit. She sensed my inexperience and was encouraging, for which I was grateful and a little defensive. (I did not want to appear inferior.) I understood the importance of the CRA/study coordinator relationship, but as my workload grew, a small part of me resented the distraction of her small talk. I was so determined to “prove myself” as an oncology monitor that my hyper focus on efficiency nearly blinded me to the opportunity to build a strong site dynamic, which would serve the bigger picture far longer than the immediate data retrieval task. 

As a new monitor, I had two strikes against me when it came to regional travel. One, I was from California. Two, I was still new to the CRA role. This made me slow to consider changing weather conditions and how to prepare. While collecting my rental car for my third monitoring visit to the site, I encountered a small, strange device not previously present in the trunk. It looked like a tiny shovel. Perplexed, I asked the rental car attendant what it was. “For the snow…” he said. 

I decided to ignore the sarcasm in his voice. “It’s only October,” I replied. 

He rolled his eyes slightly at my linen coat and open toed boots, and walked back to his booth. 

I put the attendant’s strange behavior out of my mind as I drove to my hotel under clear skies. I had more to worry about with the impending site visit. They had screened a new patient since my last monitoring visit, and I was not yet through the case books of the three still receiving the study drug. Add the task of drug accountability and the slow progress my inexperience demanded, I faced an overwhelming task. I could not afford any distractions—like the study coordinator’s chattiness. 

The first day on site was productive and I could not have gotten through all of the data without the study coordinator’s assistance.  

The morning of the second day, a call was transferred to my hotel room. It was the study coordinator offering to give me a ride to the site. Her offer was strange as she knew I had a rental car. Did she think me so green and incapable that I even needed help to the site? I politely declined and told her I would see her shortly. My insecurity was on high alert.

As I excited the hotel lobby to the blanket of white that was the parking lot, I regretted the ignorant pride that caused me to decline the study coordinator’s kind offer. A foot of snow had fallen overnight. She wasn’t patronizing me. She knew I lacked snow chains for the tires, and she drove a four wheel pickup truck. Now I had to face the elements unprepared. 

I slipped twice traversing the parking lot and was forced to use a credit card to scrape a small viewing space in my frozen windshield as I had forgotten the ice scraper in the trunk. It took twenty minutes to drive the three miles to the site, and my chafed hands (and ego) ached. 

During the drive it occurred to me the small talk and random kindnesses that annoyed me were the building blocks to a solid partnership; the very tools the study coordinator had been trying to use that I so ignorantly rebuffed. I learned a strong lesson that cold morning and vowed to value the small courtesies that embodied true professionalism, the behavior the study coordinator demonstrated. 

I arrived to the site partly frozen and thoroughly humbled. The study coordinator ran my cold hands under warm water and offered her woolen coat to my chilled shoulders. Not one word of reproach was spoken. I did take the opportunity to thank her for the fantastic work on our study, and for the kindness she had shown me. As an afterthought, I asked about her children. 

Due to project re-organization, I never returned to that site. But I did return to that town 17 years later for a pre-study visit. The study coordinator at that site knew the study nurse with whom I had worked 17 years prior, and confirmed that she was still there. “What a nice person she is” the study coordinator declared. 

“She sure is.” 

The smallest courtesies are the most effective tools to a lasting relationship.  

 

Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She also is author of the novella Clinical Research Trials and Triumphs. Currently she works in relationship development/study startup in the CRO industry. Email ebwcra@yahoo.com or tweet @ebwcra.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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