#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.  

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Monitoring During COVID-19 - Interview with Jasmine Smith, Senior CRA

#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. 

Types of Monitoring Visits Overview

#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! 

Where have I been?

#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. 

Site Updates or Issues and the Domino Effect

#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. 

Monitoring Tips Q&A

#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 regarding Source Document Review in addition to the Investigator Site File.

Consistency In Monitoring

#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. 

Monitoring Tools

#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.

Principal Investigator 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.

Discussion of FDA Guidance Regarding COVID-19

#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.

CRA Soft Skills

#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 addition to subject safety, one of our primary obligations as a CRA is to ensure data integrity and quality. Essential documents demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. The Investigator Site File, aka Regulatory Binder, and the TMF, should be audit ready at all times. In this particular episode I focus on the Delegation of Authority Log and training documentation.  Join me, as I share some helpful tips for successful Reg Binder review.

Common Audit Findings_Missing or Incomplete Essential Documents - Delegation Log

#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, provided to only eligible subjects at the protocol specified doses, and stored appropriately in order to ensure it is stable, safe, and effective for subject use.  This is my favorite area, and I could go on and on regarding study drug LOL. Join me, as I share some experiences from my monitoring journey, as well as, tips for successful IP review.

Common Audit Findings_IP Accountability

#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 regulatory decision making and approvals.  We need to ensure that trial data is of high quality as these are patients’ lives. Join me, as I share some experiences from my monitoring journey, as well as, tips for successful AE review.

Common Audit Findings_AE Review and Reporting

#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. Join me, as I share some experiences from my monitoring journey, as well as, helpful tips for CRA review.

Common Audit Findings_Source Docs and Subject Eligibility

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 in regard to 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 for CRA review.

Common Audit Findings - Informed Consent

Ready to become a Clinical Research Associate, and you wonder what to do next, or what prerequisites are required? Have you been applying for CRA positions with no response? Or, are you new to the CRA role, and wonder what to expect? These are some questions that Clinical Research Professional, Elizabeth Waddell, dives into on her Let's Get Clinical Podcast. In addition to her online courses and step-by-guides, each episode is designed to help YOU pursue a career in clinical research while providing foundational tips that will help transition to a successful CRA career. Elizabeth comes from 18+ years of clinical industry experience that includes time as a road warrior CRA and Clinical Operations Manager/Trainer. Elizabeth's specialty is her communication style, love for people, and the desire to see those succeed in their dream career. Discover the intricacies of the CRA role, and tips to excelling in this amazing career as a Clinical Research Associate.

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Let's Get Clinical, Tips From The CRA Helper

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