Let's Get Clinical, Tips From The CRA Helper

#021 - The COVID-19 pandemic has affected so much including the clinical research industry.  Have you wondered how this will affect monitoring as a Clinical Research Associate?  

During this episode, I will be talking with Jasmine Smith and I am so excited!  She has over 6 years of clinical research experience and is a Senior CRA.  Jasmine is knowledgeable with Risk Based Monitoring, 100% Source Data Verification, Unblinded, and Remote Monitoring.  She is experienced with Phase II and III studies in the following therapeutic areas: Vaccines, Cardiovascular/Vascular Disease, Rare Disease, Gastroenterology, Endocrinology, Musculoskeletal, Pediatrics/Neonatology, Rheumatology, and Nephrology/Urology.

Join us, as we discuss helpful travel tips and monitoring during COVID-19.  

#020 – If you are new to research, you may not be familiar with the types of monitoring visits that CRAs perform.  In this episode I will address questions regarding monitoring visits and why each type of visit is required.  Yay!!  Join me for Q&A, as I share some experiences from my own CRA journey. 

#019 –Have you wondered what happened to me?  LOL!  So sorry for fading out, but I do have a good reason.  In this episode, I will tell you where I have been and what I have been working on.  I’ll give you a hint, it involves a new course 😉 Join me as I share details regarding the course, my purpose, my passion, and some experiences from my own CRA journey.  See you there! 

#018 – Have you ever heard the term domino effect? Where something sets off a chain of events? This happens MANY times in monitoring when there are changes at a site, or an update with regulatory documents. One thing can cause a whole domino effect. In this episode I will discuss different scenarios when monitoring and the chain of events, or documents, that follow. Join me as I share some experiences from my own CRA journey, as well as helpful tips to monitor efficiently. 

#017 – It is time for Questions and Answers!!  In this episode I will address listener questions. Yahoo!!  Have you ever wondered how to develop good monitoring visit routine and habits? What tools to help keep organized and meet deliverable deadlines? How to calculate study drug compliance? Tips to getting your start as a CRA? Join me for Q&A, as I share some experiences from my own CRA journey, as well as helpful tools to monitor efficiently. 

#016 – Monitors are responsible for ensuring subject safety and data integrity. As a CRA, sometimes I felt like a detective on-site looking for clues in order to verify compliance with the protocol, GCPs, and federal regulations.  What happens when these “clues” are inconsistent? In this episode I discuss the importance of consistency in monitoring, and ways to ensure data is reliable. Join me, as I share helpful tips to think about when reviewing source documentation in addition to the Investigator Site File.

#015 – Do you ever wonder how a CRA knows where to begin at a monitoring visit, or what to do next? On this episode, I discuss helpful monitoring tools for all visit types. When a CRA is well prepared for a visit, it will go smoother, and save so much time. Each monitor is unique regarding what works for them, but I wanted to share what specifically helped me. Although everyone may have a different method, the end goal should be the same: subject safety, data integrity, and doing our jobs with quality. Join me, as I share some experiences from my own CRA journey, as well as helpful tools to monitor efficiently. 

#014 – In previous episodes I reviewed the Delegation of Authority Log. Although the PI maintains this list of appropriately qualified persons to whom he/she has delegated significant trial-related tasks, it is important to remember that the PI is ultimately responsible. The PI is more than just a signature and is responsible for overseeing all site activities. We as monitors, must ensure that the PI at each site is involved, and appropriately overseeing the study. In my career I have seen various levels of PI involvement, from one extreme to another!! Join me, as I share some experiences from my own monitoring journey, as well as helpful tips in verifying PI oversight.

#013 – One of the soft skills that I discussed last week, is the importance of being able to adapt to change. There is an example now causing so many changes, affecting all areas of the clinical research industry, COVID-19 (Coronavirus Disease 2019).  The FDA recognizes that this pandemic is going to impact the conduct of clinical trials, and recently issued a guidance document for industry, investigators, and Institutional Review Boards regarding the conduct of clinical trials of medical products during the COVID-19 pandemic. Join me, as I review and discuss this guidance document and its recommendations for clinical trials.

#012 – In addition to knowledge and experience, soft skills are so important for a CRA to possess. These skills can range from being able to adapt to changes, time management, being coachable, the ability to have difficult conversations, being able to deal with difficult people, being passionate about customer service, and having empathy for others. In this episode I discuss the importance of soft skills while sharing some experiences from my own monitoring journey. Join me, as I discuss successful tips in monitoring and site relationships.