Introduction To The CRA Helper And How The Journey Began

Uncategorized Dec 30, 2019

Hi and welcome!!  This is my FIRST blog ever, so it is definitely another milestone for me LOL. In this post, I wanted you to have a chance to know me better, while giving you additional details regarding my background and experience.

Well, I've been in the clinical research industry over 18 years, and as a manager, I interviewed many aspiring CRAs. So, I know that we all have a different story to tell regarding how we got our start in the industry, and how we got our foot in the door.  It's so funny because when I go to a face-to-face meeting, like an Investigator Meeting, or even to a site with a co-monitor, one of the first things we talk about is how we started in our CRA career.  You could have a whole team of Clinical Research Associates with different pathways of how they got started in the role. 

So, here's my story:

I went to Campbell University in Buis Creek, NC.  Gooooo Camels!!  I was one of those students that changed their majors multiple times. One thing that never changed though, was the love of the medical field and wanting to be involved in medicine somehow. All through junior high, and high school, I actually wanted to be an optometrist. I'm not sure what then diverted me to pediatrics and then thinking of neonatology...hmmm….probably my love for kids LOL!! By the time I rolled into college, I started as pre-pharmacy, then biology, and then there was a NEW major offered....drum roll please....

So, picture this, I was walking with two of my friends and one said, "look, here's this brochure regarding a new major called clinical research". I was really excited and was like, "yeah, let's do it"!!  My two friends and I were actually the first three undergrads in the clinical research program at our school. In addition, we took quite a few classes that went towards our master's as well.

During the last part of the program, we completed an internship, and mine was at Bayer in the compliance department.  This role was involved with GMPs, Good Manufacturing Practices, rather than GCPs, Good Clinical Practices.  One of the directors at school said he really wanted to see me get involved on the clinical side, and little did he know, that would eventually happen!!!

After graduation, I interviewed with Wyeth, before they were acquired by Pfizer, for a position working in the lab.  I was offered the job, but I also received a call from a recruiter regarding an In-House CRA position with a CRO.  The roles were in two totally different directions!  I thought about it, chose the In-House CRA position, and thank God I did! 

I was an In-House CRA for about a year, and there's actually so much experience you can gain in this role. I conducted remote monitoring visits, and completed trip reports based on those visits. I also was responsible for contacting sites between visits and documenting each correspondence. I performed QC of essential documentation to ensure they were ready for submission to the IRB as well.  This next part will definitely show my age, those days we still faxed hee hee.  We actually would send mass correspondence out to the sites via fax, or to request feedback that was needed. 

In addition to these site contacts, we also had a study hotline.  If sites had protocol or study related questions, they would call the hotline number rather than trying to contact and track down their onsite CRA. We had schedules of who would man the hotline at different times through 8pm, EST, and no one wanted that shift LOL.  Just kidding, but the hotline was open until 8pm, EST in order to accommodate the West Coast sites.

So, as you can see, there was a lot of experience that I gained as an In-House CRA.  I stayed in that role for about a year before transitioning to the clinical department as a CRAII, and that started my onsite monitor, and road warrior career, for the next 14 years!! I do have lots to share regarding the experience and knowledge that I gained during this phase of my career. So, more to come on that in future posts.  

As a Senior CRA, my manager would ask me if I ever wanted to be a Lead CRA or a manager. Honestly, I was content in my role unless something became available with training, because training and mentoring were my absolute passion (and still is!!!). So, if anything became open in that area, I definitely would have considered transitioning, but other than that, I was content being a Senior CRA. It was definitely a blessing of an income, and an amazing career, so I was fine.  

One day (and I can still picture it), I was in my backyard letting my dogs out, and my manager called stating that she put my name in for a managerial position that involved training new CRAs. I was completely excited and like, "yes, yes, yes, I'm interested"!!  I then interviewed for the position and thank the Lord, I got it, and the rest is history. I trained and managed CRAs for the next three years. This training included new CRAs coming into a 12-week program, and those that had some performance issues that needed extra help.

This is just my story. There are multiple pathways that someone can take in order to get their start as a CRA, and this is something I'm definitely going to focus on during my upcoming course in January called “Bring Your Dream Job To Life!”.  In this course I am going to review the different avenues for the aspiring CRA to get started, and will also include 1:1 time with each person. There will be five 1:1 coaching calls where I will answer questions, provide coaching, and discuss individual backgrounds.  Everyone has their unique background and skill sets to bring to the table. I want to research the best possible option to get your foot in the door. I also want to help you with completing your Curriculum Vitae (CV), and making sure it is in good shape to stand out in the application process. Lastly, I want to ensure that you stand out in the interview process for sure!!

I interviewed many aspiring CRAs as a Clinical Operations Manager.  When asked if they knew the role of a CRA, the top answers I would get were, "CRAs are the main line of communication between the site and the sponsor, and they have to make sure that sites are completing the study correctly per protocol".  This is definitely a portion of what a CRA does, but for those that didn't really expand on the details, I wondered if they really knew what a CRA was responsible for. 

Again, while yes, these are things that a monitor does, there's definitely so much more. In addition to ensuring compliance with the protocol, a CRA must also verify compliance with GCPs and regulatory requirements. Two of our biggest obligations are to confirm subject safety and data integrity. There are so many processes, tasks, and responsibilities that a CRA must perform in order to accomplish this.

Please know that I am not trying to sound salesy at all, and these details will only be on my first blog post, guys 😊  I just wanted to touch on what the upcoming course consists of, and why. 

In the course, I also want to teach, and lay the foundation regarding all things CRA. From reviewing all types of visits a CRA performs, the purpose of the visits, reviewing task completion step-by-step (on and off-site), and how to manage time with conflicting priorities. In addition, I really want to walk you through the correct, quality way, to complete each step. For example, study drug, aka, IP accountability. How do you complete this task, and what is reviewed/confirmed?  IP accountability is like one big puzzle, and I want to help you perform this task with quality.  IP accountability is one of my favorite topics, so I will try not to stray off too much LOL. I definitely want to help you learn each and every CRA task step-by-step, how to do it, and to do it right.

Now, of course, there will be Standard Operating Procedures, or SOPs, that you have to review when you're hired at a company. Due to this, there may be company specific things that they will require as well. I want to teach you based on GCPs, regulations, and my knowledge/experience from my 18+ years.

It's funny, because those of you with a coordinating or research assistant background, may have already taken ICH/GCP training, and you might be wondering, “I have my CITI certification, or NIH certification already, so why do I need to hear you talk about it?”…LOL!!!  I'm only kidding, but when you take it again, you'll be seeing it from a CRA perspective. You're going to have that CRA hat on because when you took it before, as a coordinator for example, you're thinking from the coordinator mindset and how that helps you do your job as a coordinator.

Well, this time we're going to look at it from a CRA perspective. For example, the roles and responsibilities of a clinical research monitor, as well as, how a CRA confirms/verifies that sites and IRBs meet their obligations as well.

You do NOT have to take this course in order to be a CRA. I would NEVER want you to think that, by any means. However, having a strong foundation is going to give you confidence when you interview. It will give you the knowledge to stand out against someone with a similar background.

For example, I could be interviewing two study coordinators. They have the same education, same years in research, both sites have a person delegated to data entry, and another for maintaining the regulatory binder/essential documentation. So, when these coordinators are interviewed and asked about reg docs or EDC query resolution, for example, it may be difficult to answer some questions as they didn't work with these things on a day-to-day basis (as other site staff was delegated to perform those tasks).  With the training in this course, you will be able to answer all interview questions with confidence even though you may not deal with the task on a daily basis.  

Lastly (and this is the last thing as I do not want you to think this is a sales blog LOL), I want to lay a foundation of quality monitoring that you can take with you wherever you go. Because quality is so important in this industry and drugs being approved, and it's so important to me. I've always had that work ethic. That's just who I am, and it would make my heart sink when I took over a site from a Senior CRA, and I'm wondering what in the world went on here. I would think, oh my gosh, what happened?  As in any job, people can develop bad habits.  So, I want to teach you quality, how to do it right the first time, and teach you the right way from the get-go.  Then everything in addition that you learn from your company, it is going to build on top of that foundation.

So anyway, more to come in future posts lol….If you do want to learn more regarding the January course, you can find this information on my website. I am offering an early bird registration until January 15th which will include a $100 discount. Check it out 😊

I want you to be successful and I want you to have that dream job. If you like what you are reading, click subscribe to take this journey with me.  In the next post we are going to have fun with time management LOL.  I know you can't wait hee hee.  Have a great day and thank you so much!  Until next time……


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