Let's Get Clinical, Tips From The CRA Helper
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 19+ 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 for excelling in this amazing career as a Clinical Research Associate.
Episodes
21 episodes
Monitoring During COVID-19 - Interview with Jasmine Smith, Senior CRA
#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 Jasm...
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Episode 21
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37:38
Types of Monitoring Visits Overview
#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!!&nbs...
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Episode 20
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9:35
Where have I been?
#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 involve...
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Episode 19
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11:10
Site Updates or Issues and the Domino Effect
#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 ef...
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Episode 18
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14:57
Monitoring Tips Q&A
#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 deli...
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Episode 17
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13:19
Consistency In Monitoring
#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 hap...
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Episode 16
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16:11
Monitoring Tools
#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 ...
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Episode 15
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27:30
Principal Investigator Oversight
#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...
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Episode 14
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18:01
Discussion of FDA Guidance Regarding COVID-19
#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 ...
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Episode 13
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16:04
CRA Soft Skills
#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 ...
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Episode 12
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17:05
Common Audit Findings_Missing or Incomplete Essential Documents - Delegation Log
#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/incomple...
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Episode 11
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13:53
Common Audit Findings_IP Accountability
#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 ...
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Episode 10
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15:22
Common Audit Findings_AE Review and Reporting
#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 re...
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Episode 9
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23:48
Common Audit Findings_Source Docs and Subject Eligibility
#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...
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Episode 8
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24:43
Common Audit Findings - Informed Consent
#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 i...
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Episode 7
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12:51
Tips for the Home-Based CRA
#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 remo...
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Episode 6
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19:57
Tips For Monitoring Visit Reports
#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 impo...
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Episode 5
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23:18
CRA Tips For Travel - Part 2
#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 packi...
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Episode 4
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34:41
CRA Tips For Travel - Part 1
#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 Cli...
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Episode 3
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26:31
CRA Challenges With Time Management
#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, plann...
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Episode 2
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21:23
Introduction To The CRA Helper And How The Journey Began
#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 li...
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Episode 1
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13:06