Beginner CRA

CRA BASICS, TIPS AND CAREER DEVELOPMENT FOR ENTRY LEVEL CLINICAL RESEARCH ASSOCIATES OR THOSE INTERESTED IN BECOMING CLINICAL RESEARCH ASSOCIATES

About the Author

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Hi, my name is Sara. I am a single twenty-something professional living in New Jersey. I grew up on the West Coast and went to college on the East Coast. I went to graduate school shortly after completing my undergraduate degree and was immediately was hired in the drug development industry after graduating. I have 3 years of Phase I to Phase IV clinical operations experience in several therapeutic areas for trials in the US, Canada, South America, and Europe. I  worked my way up to the Clinical Research Associate position and would like to share with others how I was able to achieved this goal in a short amount of time.  If you want to be a Clinical Research Associate or curious to know what it means to be one, this is the place for you.

Please send me any specific questions you may have at BeginnerCra@gmail.com.

16 comments on “About the Author

  1. Jacob
    September 10, 2013

    Hi Sara,

    I would like some coaching from you for CRA interview. I will appreciate if you could drop an email at jacobbrosnan1987@gmail.com. I have my interview on thursday (09/12/2013) so i will appreciate any help.

    Thank you

  2. William Travis
    October 28, 2013

    Hi Sarah,

    Your awesome and have a huge heart for creating this website. Sarah Im 43 yrs old and am looking for a career change. I dont have a college degree, but the future growth Prospectus on this industry is phenomenal!

    Where and how do I start?

    Preq courses on line?

    Whats the easiest path of least resistance considering im a non traditional student that will have to chip away at this part time?

    My email is btravis2013@gmail.com

    again TY!

    Bill

    • beginnercra
      October 29, 2013

      Hi Bill,

      Thank you so much for your comment. I truly appreciate it. You are right on the money. I think getting a bachelors of science is the first step for you. Online, community college or whatever works for you. while going to school part time you can work as a clinical trial assistant or as an assistant study coordinator, which will give you the experience and background for a CRA job once you graduate. Remember education is important but experience is essential.

      Good Luck.

      -Sara

  3. Stacey
    December 16, 2013

    Hello Sara! This is a really insightful blog! I’m definitely going to recommend it to my friends who are wanting to become CRAs. I’m currently a CRA and it is definitely not the most glamorous job. I’m a single (not by choice) 30 something CRA and I agree with you whole heartedly about the pros and cons of this industry. Thank you for taking an honest leap of faith to start this blog. Where do you find the time to do this extracurricular activity! Lol!

  4. amanda squires
    July 28, 2014

    Hi Sarah, This is a very helpful blog, and I am looking forward to more posts! I am nervous my CV is not set up in the best way, I was wondering if you knew of any places or sites to go to have it cleaned up for a clinical research associate role. Thank you!! and cant wait for your next blog!

    • beginnercra
      July 29, 2014

      Hi Amanda,

      I have been receiving the same comments in emails and I have been getting CV’s sent to my email. however because of the sheer volumn I have decided to focus only only individuals that are serious about getting their CV reviewed. Please see my blog post about getting your CV reviewed and get my suggestions in my ” Get your CV reviewed” blog post -Sara

      • Amanda Squires
        July 30, 2014

        That is perfect Sarah, I am currently in the UK. Are there differences for the cv? Also will your pay pal accept GBP?

        I will finalize my CV and send it your way! 🙂

      • beginnercra
        July 30, 2014

        Hi Amanda,

        If you try the Paypal link and it does not work please let me know and I will send you another link that is currency specific.

      • Amanda Squires
        August 6, 2014

        Hi Sarah, I am sending my revised cv tonight as there is a very rare position position posted here in London for a junior cra for a top 20 CRO. I was wondering if I should send my current job description as well as the posted position advert. I am finding it difficult to hit the buzz words and stay true to what I do.

        Thank you.

        Amanda

  5. Sarah
    January 28, 2015

    Hi Sara,

    Hopefully you can help me with a question that I can’t seem to find an answer for. I work as a trialcoordinator in the Netherlands and I wonder who is allowed to receive an informed consent from a patient. If a patient is handed a copy of an informed consent, has taken the time to read it and at a later time signs it and hands it over to me, would that be allowed? Does a physician legally have to have a consultation with a patient before the patient signs the informed consent?

    Thank you so much.

    Kind regards,

    Sarah

    • beginnercra
      January 28, 2015

      Hi Sarah, Please note that I am not 100% familiar with specific regulations pertaining the Netherlands, however per GCP-ICH guidelines and common industry practice the subject should have been consented by an individual who is trained by the sponsor on the protocol and in the informed consent. If the sponsor or CRA assigned to the study, has trained you to consent subjects or the PI who had been trained by the sponsor or CRA assigned to the study, is responsible for training anyone on his/her team on that task before they are allowed to perform it. In addition to having the training this training should be document in the Study File Notebook and your name should have been added to the delegation of duties log with consenting subjects as one of your delegations and the date that duty was given to you.
      The Investigator/or designee must obtain the informed consent of the study subjects. The subject and the person obtaining the informed consent must personally sign and date the Informed Consent Form. It sound to me like you may have received the ICF after subject was consented by someone else.

      I hope that helps you a little. Please reach out to me if you have anymore questions.
      Sara

      • sarah
        January 31, 2015

        Hi Sara,

        Wow, great, this helps a lot! Thank you so much for your effort!

        Sarah

  6. Liz
    March 12, 2015

    Hi Sara,

    I have been in the clinical research industry for about 5 years, starting out from the bottom and moving my way up. Finally the time has come and I was recently offered a traveling position to be a unblind CRA. I’m beginner CRA, YAY! I am both excited and nervous. What was your first CRA experience like? I want to make these visits go as smooth as possible from the traveling to completing the visit. Any advice would be wonderful to this newbie!

    • beginnercra
      March 23, 2015

      I would recommend you read your monitoring plan and Monitoring report template. These will give you the most information in a short amount of time of what you need to keep your eyes out for at the site. Have you study manager’s number on speed dial. Do not hesitate to call him/her if you come across anything unfamiliar. I might do a post on what my first time monitoring was like! Thanks for the idea.

  7. Hope-to-be-CRA-soon
    March 24, 2015

    Hi Sara
    I have 5+ years of experience and even single-handedly helped my PI setup a research site that grew up to be a “collection” of sites participating together. As a part of site, we got several trials and ran them. I did coordinating in some, and then moved on to monitoring participating sites on behalf of my PI. Hence I developed monitoring experience. I learnt everything on the job, with some advise from friends who are CRA’s. I was not formally trained by anyone to be a CRA. Learnt everything in my 5 years experience. Still, when I apply to CRO they say “how come you say you can do monitoring when no one taught you rigorously?” How do I handle that??
    Through all these years, I know what it takes to monitor a site and look for areas where protocol/GCP may have been breached. So how do I answer the question that I just mentioned above? Thanks so much!

  8. Ying
    July 9, 2015

    Hi, SARA
    I have 7years of pre-market drug safety evaluation experience and 2 years of post-market drug adverse events evaluation experience in China. I also have a Master in Public health in U. S. and a Master in Pharmacology in China. But It is very hard to find a clinical research job after graduation in May,2015 because they want clinical experiences first. Can you give some suggestion about the resume key word, or relevant advice regarding job searching?
    Thank you!

    Ying

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