![Mario DeSouza](/img/default-banner.jpg)
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Mario DeSouza
United States
เข้าร่วมเมื่อ 29 มิ.ย. 2007
Hi, I am Mario and I have been working in clinical research for over sixteen years. I was a Clinical Research Coordinator for the three years, two years at the Dana-Farber Cancer Institute and one year at Stanford, and I have been a Clinical Research Associate for over thirteen years. My main therapeutic focus is in oncology.
I enjoy teaching, mentoring and guiding those looking to break into or advance their career in clinical research.
I am also very interested in personal finance and am part of the Financial Independence and Retire Early community. While I have no intention to retire soon, I do hope to one day be financially free.
I enjoy teaching, mentoring and guiding those looking to break into or advance their career in clinical research.
I am also very interested in personal finance and am part of the Financial Independence and Retire Early community. While I have no intention to retire soon, I do hope to one day be financially free.
CCRA Exam Prep: E6 (R2): Good Clinical Practice - Part 2
Prepping for the Certified Clinical Research Associate Exam
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วีดีโอ
CCRA Exam Prep: E6 (R2): Good Clinical Practice - Part 1
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Prepping for the Certified Clinical Research Associate Exam
The Clinical Research job question I'm often asked that I can't answer
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Living in country X, how do I get a job as a CRA or in clinical research in country Y.
CCRA Exam Prep: E8: General considerations for clinical studies
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Prepping for the Certified Clinical Research Associate Exam
CCRA Exam Prep: E9: Statistical Principles for Clinical Trials
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Preperation for the Certified Clinical Research Associate Exam
CCRA Exam Prep: E11(R1): Clinical Investigation of Medicinal Products in the Pediatric Population
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Prepping for the Certified Clinical Research Associate Exam
ACRP CCRA (Certified Clinical Research Associate) Exam - Overview
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An overview of the Association of Clinical Research Professionals CCRA exam.
Clinical Research Coordinator (CRC) to Clinical Research Associate (CRA) Bridge Program Interview
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CRC to CRA interviews.
What clinical research role is right for me?
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CRC, CTA, in-house CRA, CRA, Project Manager, Data Manager, Quality Assurance, Regulatory Affairs?
How to have a difficult conversation with the Principal Investigator as a CRA.
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How to have a difficult conversation with the Principal Investigator as a CRA.
Do I know nothing? Is being a Clinical Research Associate (CRA) worth it? How do I become a CRA?
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In this video, I walk through a comment left on TH-cam and answer several Reddit questions.
Pros and Cons of being a Contract Clinical Research Associate (CRA)
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Pros and Cons of being a Contract Clinical Research Associate (CRA)
Clinical Research - Getting your foot in the door (entry-level positions to consider)
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Clinical Research - Getting your foot in the door (entry-level positions to consider)
How to write queries as a Clinical Research Associate (CRA)
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How to write queries as a Clinical Research Associate (CRA)
THANK YOU! (500+ subs) & Soliciting topic suggestions for my future videos
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THANK YOU! (500 subs) & Soliciting topic suggestions for my future videos
Everything you need to know about Source Data Verification (SDV) as a Clinical Research Associate
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Everything you need to know about Source Data Verification (SDV) as a Clinical Research Associate
How to be successful as a Clinical Research Associate (CRA)
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How to be successful as a Clinical Research Associate (CRA)
How to get an entry-level Clinical Research Associate job
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How to get an entry-level Clinical Research Associate job
Reasons clinical sites might become problematic - Thoughts from a Senior Clinical Research Associate
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Reasons clinical sites might become problematic - Thoughts from a Senior Clinical Research Associate
How to build connection and effectively communicate with sites as Clinical Research Associate (CRA)
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How to build connection and effectively communicate with sites as Clinical Research Associate (CRA)
Effective Monitoring Visit Report Writing
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Effective Monitoring Visit Report Writing
Why Clinical Research Associates (CRAs) Burnout and tips on how to deal with burnout
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Why Clinical Research Associates (CRAs) Burnout and tips on how to deal with burnout
Clinical Research Associate vs. Nursing - Which is better?
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Clinical Research Associate vs. Nursing - Which is better?
The Entry Level Clinical Research Associate (CRA) Interview
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The Entry Level Clinical Research Associate (CRA) Interview
Answering More Reddit Questions - Clinical Research
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Answering More Reddit Questions - Clinical Research
Detailed video on the Site Initiation Visit (SIV)
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Detailed video on the Site Initiation Visit (SIV)
Answering More Reddit Questions - Clinical Research
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Answering More Reddit Questions - Clinical Research
Answering Questions asked on the Reddit Clinical Research page
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Answering Questions asked on the Reddit Clinical Research page
Detailed video on the Pre-Study Visit (PSV) / Site Selection Visit (SSV)
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Detailed video on the Pre-Study Visit (PSV) / Site Selection Visit (SSV)
Answering Viewer Question - Clinical Research
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Answering Viewer Question - Clinical Research
HI Mario,any part 3 that you woul like to share ?Thanks!
Than you ,Mario,I want the Declaration of Helsinki preparation part for CCRA,thank you for your support
Hi Mario. I was asked in an interview for a CRA role what I would do if I have to deal with a particularly difficult PI and what I would do if I have already spoken to them at length about this issue. What would I do next? Another question I was asked is : what documentation is needed for a new sub PI for a study. Please can you help me by answering these questions. Thank you so much!
The answer for any difficult PI situation is escalate to the study team. You need all updated documents for the Sub-I addition (1572, CV, Med License, GCP etc.).
MARIO…. THANK YOU FOR THESE CLEAR VIDEOS. These are so helpful. Hope you get more followers. I have shared your videos with my staff.
Hi! Where is the best place to find practice questions?
If I remember correctly, I just found free questions on Quizlet to practice. You should be able to google around for "ACRP CCRA exam questions" and find a few resources. Technically, you could also purchase a question bank though the questions are out there.
Greetings from Australia! Thank you.
Hello Mario, what is approximate time it takes to prepare for ACRP CP or CCRA or CRCC exams?
It depends on your experience level and current knowledge of regulations. I took the CCRA exam with 18 years of clinical research experience so started refreshing my knowledge 90 days before the exam by reading through the relevant ICH GCP sections for an hour a day and studied seriously for 2 weeks leading to the exam date (it would have been similar for the CP exam). I had a colleague that had 5 years of experience and she started studying about 6 months ahead of the exam with a 90 day intense study window leading up to the exam.
Hi Mario, thank you soooo much for uploading this video. I found this video very helpful. In fact, as you mention, there are no much content available in TH-cam with regard to CCRA exam. Thanks again for taking the effort for creating and uploading this content on TH-cam. I am a Pharm-D graduate and I have 3 plus years of working experience as a CRA in India. I am moving to Canada in 4 months. I am planning on appearing for this exam online. However, could you please help me understand if we need a clinical research degree to become eligible for this exam. Also, while preparing for this exam in ACPR website, I found that some of the courses listed are with Contact hours and some are not. Could you please help me understand what is the contact hours used for in those courses. How does it help. Please note, I am a member of ACPR. Thank you.
You do not need a clinical research degree to take the exam. You only need approximately 2 years of prior CRA experience. ACRP can review your CV to see if you qualify to sit for the exam. The contact hours are continuing education hours that you will need to upkeep your certification.
Can a CRA close system queries?
Can a CRA close system queries?
This will depend on the specific study. Sometimes they ask CRAs to close out system queries when they can and sometimes they say to please leave them for DM review. There's no general rule.
What about if you have CTA (clinical trial assistant) experience?
You're fine applying to CRA positions with prior CTA experience. Ideally, you'd have at least one to two years of CTA experience.
Great video. Thank you.
This has been really helpful . Thank you so much for sharing these videos
Hey, wanted to give a suggestion on a possible ytb video. could you say more abou AI in clinical research and how it will interfer on many rolls, some people say that is cappable of the AI replace CRAs and stuff
Thank you very much for the suggestion. I'll plan for a video on how AI will change clinical research.
Hi,I have done my clinical trail course Can you please refer me entry level job site’s
Your best bet for job site's are LinkedIn and Indeed.
Thank you so much. What's the best way to reach you. I'm looking for CRA training. Thank you
Unfortunately, I don't have the time at the moment. There's another person here on TH-cam, Jasmyn Adams, that you can reach out to and Dan Sfera has a CRA academy as well.
Hi there, I found you on reddit haha. Can you provide specific salaries for those who come right out f a BSN program for instance and apply for clinical research nurse positions......then apply for a CRA position (salary for this one as well)....then salary for CRA II as well as a salary for a senior level CRA and how long it would take between each role to advance. Thank you
I have a video here on TH-cam that details CRA salaries that can serve as a rough guide. That question has become impossible to answer since 2022. Some places offer unusally high salaries in 2022 that we are unlikely to see again. The salary sheet on Reddit shows that salaries are all over the place too. Research nurse positions generally pay between $75k-$100k with $85k-$90k being realistic.
Hello, thank you so much for these videos. I am a foreign MD, can I directly apply for CCRA certification? I do have several years of coordinator experience in US. Kindly guide me.
To apply for the CCRA certification you'd need to have about 2 years of CRA experience. There is a separate CCRC certification that you can take now with several years of coordinator experience.
Thank you
As a licensed social worker.. would you have any advice to get into the field as a Clinician?
I can't think of a clinican entry point as a social worker within clinical research. To do medically rated procedures, you'd need to be a RN. MSN, MD, DO or PA. The only person I know with a background in social work started off as a Clinical Research Coordinator which is a non-clinican job.
Would going back over CITI training be helpful for the exam?
I do not think it would be that helpful as it'll likely only help you answer a few questions at best. The best resource to go over would ICH E6 R2 multiple times combined with sample questions. That's where about half the exam questions come from.
Great video!
Thank you!
Another thing that may be both positive or frustrating about this job is that there is no standard job description in each company or CRO. In one company you are only responsible for monitoring, in another you are also preparing IRB submissions, investigator payments, contract negotiation. These would of course improve your knowledge, experience and oversight in clinical research but at the same time make someone really exhausted if they are done besides monitoring visits. I think it’s another reason for burnout.
Watching from south Africa. Found you when i was searching for tips on initiation visit. I am a junior CRA.
Thanks for watching. Hoping to visit S. Africa some day. Would love to see Cape Town.
"The one question that you should never ask" - So, it's common sense that the CEO of any company will make the most money so that is a given. In today's economy, with rent for a 1 bedroom in my city being at $1600 and the average cost of a home for purchase is $400K, a LOT of people are totally focused on the money.
If it’s abundantly clear your only intention is what money the job pays with no mention whatsoever of the skills you bring to the job, you’ll never be hired so it’s a moot point. The way to phrase the question is, “I’m really interested in X job for Y reasons and can I get insight into what my salary potential may be and could those skills be used in other ways that may better enhance my career.” The way not to ask the question is, “I need money so who makes the most?”
How many months are you dedicating to preparation?
I took the exam a while ago. I spend about a month total. For the first two weeks I read the regulations for 1 to 2 hrs a day after work. For the final two weeks, I increased to 2-4 hrs trying to answer sample questions. I was already really familiar with the content so most people may need more time and I'd budget 3 months for most.
Thank you so much, man.@@MarioDeSouza
Thanks, Mario!
Great detail video Mario. You indeed nailed this one.
You are doing a great service for new and even the young at heart CRAs. You do not know how helpful and ceiling breaking your videos have been. Please don't quit making them. Keep them coming.
Great Interview hints. Refreshing
Great video
Very detailed to the point and refreshing
Very much informative❤
great video, I agree
Thanks a lot
What about data manager or data coordinator..is it an entry level job?
Data coordinator at a site is usually an entry level role. Data Manager (at a CRO/pharma company) would not be entry level.
I really appreciate you sharing your knowledge!
Thank u. How do I find a job in Canada from overseas
Unfortunately, this isn't a question I can provide much insight on as I've never looked for a job in another country. My best advice would be to visit Canada and network with people that do the role you're interested in.
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Thank you for your open and honest experience in the CRA and Clinical Research areas. It is always interesting to hear from people in the real world. Some people will need to do their homework and find out what works for them as far as salaries, experience, and GCP.
Thank you Mario. Perfect timing as I have an interview tomorrow as a QS, but the recruiter told me to look for clinical quality assurance to get a better idea of what goes on and that is how I found this video! Thank you ... Thank you!!! 👍👍
This video is so helpful!
Stumbled across your page because I am preparing for a CRM interview (zero clinical research experience) but your content is seriously what I needed. It’s perfect, and I think you delivered the information is the most concise effective way! You’re someone I definitely look up to!
Thank you for watching! Really appreciate the kind words. Good luck with the interview!
Preparing for my first-ever CRA interview and came across your video!! Thanks for keeping it short and simple. I will be using your tips!
Good luck with the interview! Keep me posted on how it goes.
Thanks for the video series. I plan to study along with your video.
How about an International Medical graduate, i.e. a fresh MBBS graduate ? Can they get CRA positions in UK?
I get a lot of questions about UK/Europe. Unfortunately, I don't know much. In the U.S. it would be a challenge and I'd tell you to get a year of coordinator experience. I'm headed to London this week for the first time and will attempt to learn a little bit about how clinical research works there.
@@MarioDeSouza thanks for your efforts
I just started watching your videos and I have to say I loved watching your comfort level grow as the videos progressed. Always great info! Thank you.
Thank you for the support.
Hi there, I’d love some guidance on how to get my foot into clinical research coming from social behavioral research with a masters in public health.
Your best bet is to start as a clinical research coordinator to learn about clinical research. From there you can decide what you want to do in the future.
Hi, how would you write a query in this scenario where the exclusion criteria exclude any subject with surgery 6 months prior to screening data and the clinical site has screened and randomised a patient who had leg surgery 3 months prior to this screening? Can you tell me exactly how to issue this query?
For inclusion/exclusion criteria not being met, you first want to bring it to the attention of the study team. The only thing you might want to query (assuming you're not on-site and looking at the source) is "please confirm that data for leg sugery being done 3 months is correct as entered." If you're on-site, you need guidance from the study team. This subject will likely be withdrawn from the study and your query should be explicit with their instructions. For example, "per source, leg surgery was done 3 months prior to screening. If data is confirmed correct as entered, please withdraw the subject from the study as subject should be excluded from the study per protocol."
@@MarioDeSouza thank you
Excellent!!!