CRA Foundation Training
A 5-module course designed to lay the foundation of quality monitoring, and prepare you for a career as a CRA.
Whether you are.....
- An aspiring CRA who wants to learn how to get started with no experience.
- An aspiring CRA who wants to learn what the life of a CRA is like, and how to monitor with quality.
- A Study Coordinator who wants to shift gears and start a career as a CRA, and would like to learn more about the monitoring process.
- Someone interested in the clinical research industry and would like to learn more about the CRA role.
- A new or junior CRA who would like to learn tips and gain confidence in their new role.
- An ACRP Certified CRC who is an aspiring CRA (confirmed with ACRP that this training can be used as 8.50 contact hours of research towards ACRP maintenance renewal points) - This is a win-win!
- An ACRP Certified Professional, Principal Investigator, Clinical Research Coordinator, or Clinical Research Associate who needs maintenance renewal points, and could use the 8.50 contact hours (this would be me LOL!).
- A SOCRA Certified Clinical Research Professional in need of continuing education hours.
Then you are in the right place. I am going to tell you exactly how this CRA Foundation Training will give you the knowledge and inspiration for your journey to becoming a CRA, earning SOCRA CE's, or ACRP points ;-)
CRA Foundation Training is an expansion of the Let's Get Clinical Podcast. This course shows you exactly what deliverables a CRA is responsible for, and how to do it with quality. The best part? You can learn tons of helpful information in only 8.5 hours! As you navigate through the 15 lessons, you can jump in all at once, or go at your own pace. The choice is yours :-)
What’s Inside CRA Foundation Training
Learn from someone who has gone before you. I’ve 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.
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've 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.
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's 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's 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's YOUR turn. In this final lesson, I will discuss the different pathways that can lead to your CRA journey. Ready, set, go! Also included is an updated guide listing CRA Entry Level Companies.
After purchase, you will receive immediate access to all 15 lessons, as well as, the above guides and checklists. I want you to have everything up front in order to go at your own pace. You will also have continued access to the training material as all slides, guides, and videos will be downloadable. I want you to have everything at your finger tips as long as you need it :-)
Please note: Because all material can be accessed and downloaded immediately, there will be no refunds.
What is my purpose?
In order to be a CRA, do you need this course, or any other CRA training program? NO. I would never want you to think that or mislead you in ANY way.
My purpose for this course is to help aspiring CRAs, those who want to learn more about the CRA role, and to teach the monitoring process while focusing on quality. This training will teach you step-by-step how to be a CRA and lay a strong foundation that you can build upon.
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. 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’m ready to take you to the next level!!