Let's Get Clinical, Tips From The CRA Helper

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

Fri, 04 Dec 2020 16:00:00 -0500

#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.

Types of Monitoring Visits Overview

Tue, 24 Nov 2020 15:00:00 -0500

#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.

Where have I been?

Sun, 08 Nov 2020 01:00:00 -0500

#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!

Site Updates or Issues and the Domino Effect

Sat, 20 Jun 2020 21:00:00 -0400

#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.

Monitoring Tips Q&A

Fri, 22 May 2020 00:00:00 -0400

#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.

Consistency In Monitoring

Sun, 10 May 2020 00:00:00 -0400

#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.

Monitoring Tools

Sun, 03 May 2020 23:00:00 -0400

#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.

Principal Investigator Oversight

Fri, 24 Apr 2020 01:00:00 -0400

#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.

Discussion of FDA Guidance Regarding COVID-19

Thu, 02 Apr 2020 23:00:00 -0400

#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.

CRA Soft Skills

Sun, 22 Mar 2020 01:00:00 -0400

#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.

Common Audit Findings_Missing or Incomplete Essential Documents - Delegation Log

Tue, 10 Mar 2020 01:00:00 -0400

#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_IP Accountability

Tue, 25 Feb 2020 00:00:00 -0500

#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_AE Review and Reporting

Sat, 15 Feb 2020 18:00:00 -0500

#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_Source Docs and Subject Eligibility

Sat, 08 Feb 2020 15:00:00 -0500

#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 own monitoring journey, as well as, helpful tips for CRA review.

Common Audit Findings - Informed Consent

Fri, 31 Jan 2020 18:00:00 -0500

#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 for CRA review.

Tips for the Home-Based CRA

Sat, 25 Jan 2020 16:00:00 -0500

#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 all about boundaries, being accountable, and discipline. Join me, and let’s talk about the perks from working at home!

Tips For Monitoring Visit Reports

Fri, 17 Jan 2020 00:00:00 -0500

#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 visit reports and to be successful in all that you do!

CRA Tips For Travel - Part 2

Fri, 10 Jan 2020 01:00:00 -0500

#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!

CRA Tips For Travel - Part 1

Sat, 21 Dec 2019 16:00:00 -0500

#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, and I will give you tips for successful travel!

CRA Challenges With Time Management

Sat, 21 Dec 2019 16:00:00 -0500

#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, and even result in a PIP (Performance Improvement Plan). Join me, I want to ensure you are set up for success right from the start!!

Introduction To The CRA Helper And How The Journey Began

Wed, 18 Dec 2019 19:00:00 -0500

#001 - Welcome to the Let's Get Clinical Podcast! I am so excited to begin this podcast, and share the life of a Clinical Research Associate with you. My family will be excited too, because I can go on and on when it comes to the life of a CRA, and now someone else has to listen LOL!!

As you may know, I have been in the clinical research industry for over 18 years which has included being a CRA for 15 years, as well as, a Clinical Operations Manager and Trainer. In this first episode, I want to share my personal journey with you, and tell you about a new course coming out in January for the aspiring CRA. To learn more about the course "Bring Your Dream Job To Life!", visit www.thecrahelper.com.