Let's Get Clinical, Tips From The CRA Helper

#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 we...

#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 mon...

#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 abou...

#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 th...

#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 a...

#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 ...

#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 experien...

#011 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I discuss issues associated with missing/incomplete essential documentation. This documentation is so important and is a requirement per GCPs as they permit evaluation of the conduct of a study and the quality of the data produced. Remember, in addit...

#010 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I discuss issues associated with Investigational Product (IP) accountability. As CRAs we have a lot of responsibility when it comes to IP, which remember, is drug that has not been approved by the FDA. We want to ensure it is secure, controlled, prov...

#009 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I discuss issues associated with AE review and reporting. As CRAs our two most important obligations are subject safety and data integrity. It is extremely important that we monitor this closely, and ensure that data is reliable as this affects regul...

#008 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I am discussing the importance of complete source documentation and verification of subject eligibility. A subject that is randomized to study drug, and not truly eligible for the study, can risk a subject’s safety and the efficacy data of a trial. J...

#007 - Learning the common audit findings is so beneficial for a CRA.  It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them.  This week, I am discussing common audit findings regarding informed consent.  I will touch on issues relating to the form itself (the ICF), the consent process, and HIPAA. Join me, as I share some experiences from my monitoring journey, as well as, helpful tips...

#006 – Working as a home-based CRA sounds like a dream, right?  Working from home is definitely a privilege but be careful not to stumble into any pitfalls.  Some can get distracted, non-productive, and feel isolated when working remotely.  In this episode I will discuss tips to work successfully at home and share some stories from my own home-based experience LOL.  Being a remote CRA is such a blessing, and to be successful, it’s ...

#005 - Are you familiar with Monitoring Visit Reports, and what to include?  If not, I'm here to help! In this episode, I discuss why MVRs are required, and what they should contain.  I also review how to document issues, and the importance of corrective/preventative actions. I discuss what to document in regard to review, and the metric of MVR TAT - Monitoring Visit Report Turnaround Time. I want to help you achieve quality v...

#004  - As a Clinical Research Associate, travel plays a big part in your career.  I spent 14 years, of my 18+ year journey, as a road warrior, and want to help you.  In this episode I will discuss recommendations regarding packing, airport security, TSA regulations, tips for smoother travel, and safety. I will also share funny stories from my experience to guide you as well. Join me, and I will give you tips for successful travel!

#002 - This episode focuses on important deliverables that a Clinical Research Associate must manage between monitoring visits, why it is required to be on-time, and how important it is for a CRA to possess skills such as, prioritization, planning, multi-tasking, and organization. Time and time again, I have seen CRAs struggle in the area of time management. This can be overwhelming, lead to burn-out, affect performance reviews, an...

#003 - As a Clinical Research Associate, travel plays a big part in your career.  I spent 14 years, of my 18+ year journey, as a road warrior, and want to help you.  In this episode I will discuss monitoring visit intervals in the Clinical Monitoring Plan, tips in scheduling visits on the earlier side of the window, how a CRA schedules travel, helpful tips, safety, and the importance of a company Travel and Expense Policy. Join me,...