There is nothing more exciting to a new Clinical Research Associate (CRA) than the first independent on-site monitoring visit, for it is an enormous accomplishment demonstrative of organizational trust in the CRAs judgement, monitoring proficiency, and critical thinking.
A fitting baseball metaphor describes it perfectly; it is like being called from the minor leagues to “the show” (major leagues). In this scenario the minor leagues signify the new CRA working through a rigorous onboarding process that includes learning organizational SOPs, and the CRA role through online and instructor led training. The “show” is the actual monitoring visit observation/sign off process on the path towards independent monitoring visit conduct. This process is an industry standard across pharma/biotech. A new CRA observes an experienced CRA conducing a monitoring visit and accompanying activities (drug accountability, regulatory binder review, source data verification/source data review, PI and site personnel communication and follow up on deviations/findings from previous monitoring visits). The new CRA assimilates key information from this observation to prepare for their own performance evaluation monitoring visit or “sign off visit” (the show). During the sign off monitoring visit, a CRA evaluator will assess the new CRA completing an actual on-site monitoring visit and activities to determine sufficiency for independent monitoring visit conduct. Once authorized, the CRA beings their journey in the ‘big leagues.”
The sign off visit process is fraught with anxiety and excitement for new CRAs. The responsibilities for which to prepare are vast: learning clinical research fundamentals/guidelines for their new role, while familiarizing themselves with the protocol, monitoring plan and study systems. They are also navigating the communication/organization involved with managing regional sites. And though it is not a black and white, pass or fail process, the CRA feels the heavy burden of organization investment and personal expectation to succeed. However, once the CRA is authorized for independence, the transformative CRA journey begins.
My assimilation to the CRA role would have been more seamless had I started my journey with essential clinical research fundamentals that a program like Clinical Research Fastrack provides. I would have felt more confident during this CRA sign off transition process with the knowledge gained from attending this course.
I will never forget my first independent monitoring visit, for it was a lesson in humility and the importance of empathy. As a new CRA I was assigned to a renal failure study with fifteen sites across the Western US. My first independent monitoring visit was a two-day visit to a nephrology medical practice that had a flourishing research department. They were participating in two studies on the program to which I was assigned. The nephrologists in the practice each served as investigators on the studies they conducted, alternating the roles of Principal Investigator and Sub Investigator. The research department had a primary and back up study coordinator, research administrator and four physician investigators.
My relationship with the site had an auspicious start. On the day I planned to contact the site to schedule the monitoring visit, the lead study coordinator instead contacted me about an SAE for a study patient. They had not had a monitoring visit in a while due to high CRA turnover and they were in panic mode over the circumstances of reporting. It wasn’t exactly fertile ground for a friendly conversation about scheduling. Despite my own nervousness, I managed to provide them with the correct SAE reporting information. The last words out of the harried study coordinator’s mouth to me were, “you need to come here as soon as possible. The data is piling, and we need help.” So much for easing into site management. I scheduled my first monitoring visit for the following week.
My naïve daydream of the site visit circumstance was in stark contrast to the actual reality I would face. In my mind, I would arrive at the site and be greeted by enthusiastic and kind site personnel, who had organized the study documents perfectly in the plush, air-conditioned monitoring office they had reserved exclusively for me. The office would have a beautiful view, ergonomically comfortable chair, dedicated Keurig, and mini fridge with snacks. They would allow me to stay on site each day for 9 hours, they would be accessible for immediate corrections, and they would liberally compliment me on my eagle eye observations. I would be confident, at ease and successfully review the backlog of data and queries that had accumulated. I would leave the site a conquering hero who had successfully navigated her first monitoring visit. The reality was an exercise in struggle and self doubt; I made my discombobulated way through case books, source documents and regulatory files, while I dealt with frustrated study coordinators and a manageable working area. I was responsible for procuring both coffee, snacks and even water. The site personnel were hardworking, without the time or inclination to babysit a newbie monitor. Grounded, practical exposure was what I needed to knock my unrealistic expectations back to common sense level one, and this was accomplished during this two-day monitoring visit.
I arrived at the site that fateful day duly caffeinated and nervous. I had barely slept the night before in anticipation; thankfully the travel was uneventful. My visit preparation was thorough to the point of being ridiculous. I checked and rechecked my monitoring bag for my supplies; site folder, sticky notes, pens, laptop (thankfully I remembered it), printed copy of the last monitoring visit report, protocol and monitoring plan, (this was in the dinosaur age when people still printed documents for reference), a listing of queries to address and CRF pages pending review, pocket size pharmacopeia, business cards, cell phone charger, copy of my travel itinerary and site contacts and directions. Though a formal site transition with the previous CRA I was replacing did not occur (they had unexpectedly left the company) I was given a copy of their monitoring visit notes, which I had committed to memory. I had confirmed my log in to the EDC system and sponsor system for monitoring visit report documentation and felt as ready as I would ever be. My suit was dry cleaned and crisp, my mind was semi-alert, and I was, well, terrified. The negative feedback loop and cheerleader chant were competing for space in my head. The negative feedback loop was telling me that I was not ready, that I was in over my head, that I did not know the study/protocol/therapeutic area enough, and that I was going to fail. The cheerleader’s mantra was a repetitive exercise in encouragement; You’ve got this! You are ready, well prepared, and this is your dream. Go for it!!
I walked into a comfortable lobby and checked in with the front desk receptionist. Soon thereafter a very serious, very imposing woman came out from the busy back area to greet me. She introduced herself as the lead study coordinator, and as she led me through the door separating the lobby from the practice, she let me know quite frankly that they had needed a monitoring visit for a while, and that I should prepare myself for the backlog.
I nodded my head and assured her that I would do everything I could to help get them on track.
The monitoring room was a fulfillment of the study coordinator’s words. Paper medical charts and regulatory documents were piled high on the desk. Dialysis patients had a high rate of adverse events and there were pages and pages of data to comb through. Though the room was small, the desk was large enough to accommodate the study documents and as well as my monitoring tools. I looked at the piles of study folders that tilted precariously before me, exhaled, and began my day. My protocol was open, my computer open to the monitoring visit report, sticky pad in my left hand, and black pen in my right. The tools in my arsenal were poised and ready for battle!
The first patient chart I selected for review was coincidentally the previously mentioned patient for whom the site had contacted me about SAE reporting. There was a sticky note attached to the front of the patient’s chart, addressed to “CRA du jour” with a question about the follow up SAE reporting. I grabbed that sticky note and stared at it for several minutes, for it was more than a humorous tagline regarding the high CRA turnover the site had experienced. It spoke to the negative impact of rotating CRAs on the site and the resulting gaps in communication, documentation, and study directives. The site had inadvertently been left hanging and their frustration (evidenced by the study coordinator’s attitude to me) was certainly understandable. This simple sticky note communication lent clarity and created empathy, the cornerstones of relationship development that are so critical to the CRA site dynamic. I was thankful the study coordinator had left it for me, for the message was received.
I spent the next two days studying that site: infrastructure, personnel, communication style/process, environment, and energy. I learned site process for organizing patient research charts and accompanying source documents, regulatory binder maintenance, and supply storage. I reviewed each new patient’s informed consent form, screening and eligibility visit data, to ensure compliance. I did a high-level review of IRB and consent approvals and confirmed that all personnel on the delegation of authority log were present, appropriately delegated to each respective task that they were completing, with documentation of their experience and training to support this delegation. I developed a newfound respect for the difficulty of navigating an EDC system that tended to freeze and/or kick the user out that they had to start again. I was able to verify in the EDC system all the source documents I had reviewed/confirmed; this was not such a great feat as I had only reviewed three patients. The large learning curve new CRAs face make for slow progress.
The biggest accomplishment of the entire visit was the new relationship I started with the site. There was no miraculous resolution of issues. However, my sincerity and hard work were the first steps in reparation. The study coordinators were frustrated, understandably. They perceived me as some green upstart who would stick around for a little while to gain additional experience and then leave for “greener pastures” as my predecessors. My presence was an additional burden to their workload that an experienced CRA would not present with their ability to rapidly assimilate new site assignments and information. So, I was determined to gain a little ground, a little trust, by my actions and words.
They had heard the same superficial reassurances from other CRAs; however, my approach was a little different. I let the lead study coordinator guide the encounters; she would check on me when she had time, and then we would discuss my progress, questions, and queries. I was transparent about what I did not know and confident in what I did know. I never let on that she intimidated me terribly and instead spoke to her professionally. I also listened. I listened to every complaint, every frustration, commiserated, apologized, and let her know that I was in for the long haul. I communicated my understanding that trust had been broken and it was my goal to repair it, no matter how long it took. The study coordinator did not engage in any personal “chit chat” during these encounters, but she completed all my requests diligently and we worked well together. Not only was progress made with the CRF backlog at the site, but a foothold was established in the foundation of site partnership that would assure the research tenets of patient safety and credible data.
I worked with that site for almost two years. That lead study coordinator taught me an enormous amount about clinical research, site dynamics and how a successful research site is managed. Towards the end we even became friends and went out to dinner several times while I was in town for monitoring visits. The slow and steady approach we both employed built trust, restored faith and left us with an effective dynamic that positively impacted both CRA and site performance.
For more information about Clinical Research blogs and industry insights, visit clinicalresearchfastrack.com