CRA Foundation Training & Collaboration with ClinEssentials
Jan 23, 2021
Hi, Elizabeth here, and welcome!
In this post I will discuss my new course in addition to a new collaboration I am excited about. More to come on that 😊
So, without further ado, the new course is called CRA Foundation Training – and please do not think this is going to be something salesy. I really want to share not only what the course entails, but also my purpose, passion, and motivation for this.
I have always learned, even in church, that having a strong foundation is vitally important. With a strong foundation, a structure can stand during trials, storms, or anything, right? The same applies with learning as well. Picture the ‘structure’ as your CRA career, and you want that standing on a strong foundation. Because of this, I designed a 5-module course in order to lay the foundation of quality monitoring and prepare you for a career as a Clinical Research Associate.
This training is actually an expansion of my podcast: Let’s Get Clinical, Tips from The CRA Helper. If you found my podcast helpful, then the course will also be helpful as it goes even deeper. This training will walk you through the tasks and deliverables a CRA is responsible for, while focusing how to do it with quality.
I have been where you are, and I want to share my knowledge of this complicated industry. I want to teach you areas where even seasoned CRAs can get stuck, and some things that took me years to learn myself. I want to give you tips for successful monitoring and teach you quality from the start.
In this course, I break things down into 5 modules: starting with the WHY and leading to the HOW. The lessons include:
Module 1 – The WHY
- Overview of Drug Development - In this lesson I will discuss an overview of drug development from the lab to the pharmacy. This starts off "The Why", and where CRAs fit into the drug development process.
- Review of ICH/GCPs - Now that you have learned the process at which an Investigational Product goes from the lab to the pharmacy, I want to review the ethical and quality standards of clinical trials. You may have experience already with ICH/GCPs, but have you learned them from a CRA's perspective? In this lesson I want you to put your CRA hat on while we review Good Clinical Practices. Also included is a Beginner's Guide to Common Clinical Research Terms, systems, and common documents found in the Regulatory Binder.
Module 2 – The HOW
- Types of Monitoring Visits - As CRAs, the two primary responsibilities are ensuring subject safety and data integrity. We must visit sites in order to do this. In this lesson, you will learn the four types of monitoring visits - From the type of visit, to the purpose, to the tasks performed at each. So much to learn!! Also included are checklist templates for all 4 visit types.
- Monitoring Visit Prep and Follow-Up - Now that you know the types of monitoring visits conducted, it is time to learn what happens before and after. In this lesson, I will walk you through preparation and follow-up responsibilities of a CRA. Also included is a Routine Monitoring Visit Prep & Follow-Up Checklist.
Module 3 – The HOW (continued)
- Investigator Site File Review - Now we will begin review of on-site monitoring activities! Woo hoo!! In this lesson, I will review the contents of the Investigator Site File, and tips for CRA review.
- The Trial Master File - Now that you are familiar with an Investigator Site File, let us discuss the study file at the sponsor/CRO level. In this lesson, I will discuss the Trial Master File, the contents, and classification/platforms used for submission of essential documents.
- IP Accountability - In this lesson, I am going to teach you all about Investigational Product. I break down each item the CRA is responsible for verifying, and also walk you through the drug accountability process.
Module 4 – The HOW (continued)
- ICF/HIPAA Review - We will continue our review of monitoring tasks. Yay! In this lesson, you will learn about the Informed Consent Form and HIPAA document. I will discuss the consent process, break down the steps of review, and provide extra tips for success.
- SDR/SDV/RBM & Eligibility - In this lesson, you will learn about Source Document Review, Source Document Verification, Risk Based Monitoring, and confirming subject eligibility. Wow, that was a mouthful! I will discuss each item in detail, and then provide tips for successful review. I want you to become the best CRA in your industry, and to monitor with quality.
- Monitoring Tools - Now that you are familiar with monitoring visits and CRA responsibilities, let us go deeper and review the tools used. When a CRA is prepared for a monitoring visit, it will go smoother and save so much time. In this lesson, I will review tips and tools used at monitoring visits, and the methods that worked for me.
- Safety Reporting - Safety reporting is huge in clinical research. Remember, as a CRA, verification of subject safety and data integrity is so important. In this lesson, I will discuss safety reporting definitions, safety assessment, and PI responsibilities. I will also discuss CRA review of Serious Adverse Events, including the sponsor responsibilities.
Module 5 – The HOW (continued)
- Query and Trip Report Writing - In this module we are continuing to learn "The How". In this lesson, I will discuss two items that will be a big part of your CRA career - Queries and Trip Report Writing. I will review query examples and provide tips for generating SMART queries. You will also learn about the contents of a trip report, tips for successful completion, and how to document issues.
- Professionalism, Communication, and Site Relationships - As a CRA, being professional is key. In addition to the relationship with your study team, you will also be the main point of contact between your sites and the sponsor. In this lesson, I will discuss tips for successful relationships and building rapport, communication, professionalism, working from home, and dealing with difficult personalities.
- Time Management & Metrics - Time Management is an area that CRAs of all levels can struggle with. In this lesson, I will review deliverables and metrics that a CRA is responsible for between visits and the importance of meeting deadlines. I will also share tips for managing time that helped me during my clinical research career.
- Pathways to Becoming a CRA - Getting your start as a CRA can be tricky as most companies require experience. Have you ever wondered how to get your foot in the door? I have definitely been there! Over 19 years ago I started my journey in clinical research, and it has been a blessing ever since. Now it is YOUR turn. In this final lesson, I will discuss the different pathways that can lead to your CRA journey. Also included is an updated guide listing CRA Entry Level Companies.
In addition to the above training, guides, and checklists, there is more 😊 I am so happy to begin a collaboration with ClinEssentials, a company built by Clinical Professionals that creates and develops products to help us all become more efficient during the clinical trial process. Their products have been requested by clinical research sites, clinical research organizations, auditors and sponsors alike and are proving to be timesaving and an essential part of a clinical trial’s success!
With ClinEssential’s flagship product, the CRA Audit Notes line, clinical professionals can breathe a sigh of relief and save the time of writing the same phrase over and over across multiple patients (I have definitely experienced this!!). With 16 custom pre-printed clinical research statements (that are also color coded, by the way) you can jump right into noting the details of the task. And because of the clever color coding, everyone will know exactly where to look for the most pressing issues.
For a limited time, when you register for CRA Foundation Training you can get your free CRA Starter Bundle which includes 6 of the most popular CRA Audit Notes plus an Action Item Carbonless Pad and a Visit To Do List Pad (two other popular ClinE products!). This is a value of nearly $60 so do not forget to take advantage of this great freebie while you can!
You can check out all of the CRA Audit Notes as well as other great, time-saving products at www.ClinEssentials.com.
In addition, for those that are already certified through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA), it was confirmed that this course can be used as 8.50 contact hour points/continuing education hours for maintenance renewal.
Clinical research has been a big part of my life and has been such a blessing. I have been in the clinical research industry for 19+ years, with the last 4 years focused on training and development. Most entry level companies require a knowledge of ICH/GCPs, familiarity with the drug development process, and time management skills which this course will review. Again, I want you to gain a strong foundation, be confident in the interview process, and have a step above the rest!! You have shown initiative and motivation by being here, two qualities an excellent CRA needs to possess. I am ready to take you to the next level!!
You can learn more on my website, and if you have any questions feel free to DM me on any of my social media platforms.
Thank you so much, and I pray you guys are safe and doing well.