What is an average day like for a CRA?

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Jacob Brosnan in Charleston, South Carolina

14 months ago

Sara said: Hi am a CRA I have blog where I talk about some of the basics of being a CRA check it out beginnercra.wordpress.com. I plan on including some hands on stuff how to get started the right things to say on an interview. I also offer coaching so if you are interested please check it out at beginnercra.wordpress.com

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

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Alex in Melbourne, Australia

13 months ago

Please help to clarify!
Are there differences between CRA (Clinical Research Associate) and CRS (Clinical Research Scientist)?
Thanks a lot in advance

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d-digger in Wilmington, North Carolina

9 months ago

Mather in Pittsburgh, Pennsylvania said: The CRA gig is not cut out for everyone. It's a tough job and you have to love what you are doing. A CRA's job is to:
...
Here's a list of things that CRAs do and find joy in:
-Working with a new group of people every day.
-Working with a new electronic medical records system everyday.
-Playing a bit of detective
-Playing the bad guy and asking doctors/nurses to prioritize the your study. When the sponsor changes their mind and a site has to re-do a significant amount of work, you are the one to break the news to them and work your magic to make sure it gets done.
...

Mather, could you elaborate on "When the sponsor changes their mind and a site has to re-do a significant amount of work"? A few cases would go a long way.

Thanks in advance.

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James Wacker in Seattle, Washington

9 months ago

d-digger in Wilmington, North Carolina said: Mather, could you elaborate on "When the sponsor changes their mind and a site has to re-do a significant amount of work"? A few cases would go a long way.

Thanks in advance.

If the sponsor makes a large amendment to the study, the site will have to go and change a bunch of what they have set up to match what the new protocol wants. This could involve changing physician, nursing, lab, radiology, pharmacy, or coordinator processes which is an annoying this to do. However, everyone knows amendments happen and usually are annoyed by but understanding of them.

Mather is probably moreso referring to if a sponsor decides not to open a study (after the sites have already spent lots of time preparing) or to alter their plans for how the study will be implemented.

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Mather in Pittsburgh, Pennsylvania

9 months ago

Digger,

That could happen in a multitude of ways:

1. A site spends a lot of time developing advertisements and obtaining IRB approval and then protocol change is made and then they have to make all new ads.

2. Sponsor wants to capture more details in the eCRF, so they add a new CRF page that has to be completed for all subjects.

3. Sponsor audit is done and auditor mentions that delegation of authority log only says "labs" and doesn't distinguish between drawing labs and interpreting labs, so they make every site study-wide re-do all their delegation of authority logs.

4. Sponsor finds out drug is unstable / DMC results are unfavorable so they immediately shut down study.

5. Protocol amendments

6. Issues with protocol that require study-wide telecons and retraining.

7. EDC guidelines that say one thing but when it's time for data lock, they change their mind and query everything and require sites to change every ug to mcg for every dose amount.

8. There's a new system introduced and you'll need to register for access, complete training and change your processes and procedures.

The list could go on- if there's one thing you can count on in this industry, it's change!

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KellyJ in Newark, New Jersey

8 months ago

Hello All CRAs,

Could anyone of you please answer this interview question?

1. What would you typically do when you have a very short time or limited time at a site for a monitoring visit?

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Researcher 1 in Lafayette, Indiana

8 months ago

I would never plan a monitoring visit where I knew I would be short on time. Common-sense Prevention is key, but unfortunately sometimes the best made plans do not work out.... But one must first ensure that poor planning isn't the issue.

I would set my priorities in this manner:

1. Meeting with PI/CRC.

2. Subject safety (informed consent, SAEs, subjects I've identified ahead of time that will have problems/deviations related to safety.

3. Data lock goals

4. Patient visits where end points are measured

5. Drug accountability (a huge potential subject safety issue in the event of IP misallocation)

6. Regular subject visits/Non-database lock data points and queries in EDC

7. Regulatory binder

8. Checking to make sure site has adequate supplies

9. Checking frozen samples (if applicable)

10. Correspondence section of ISF

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Ernie S. in Concord, California

3 months ago

There are no correct answers here. The interviewer probably wants to find out your thoughts and approach. My answer would be:

"If I had only a short monitoring visit (1 day), priority and advance preparation is probably the key. 1 or 2 weeks before the actual site visit, I would make a list of items that need more urgent attention and ask the site to have things prepare before I arrive. This will ensure that no time is wasted looking people or searching for missing records. An example would be to set up a definite time in advance with the PI, request subject files and medical records for subject xxx to xxx to be pulled, and make sure that the site coordinator will be available on that day to answer any question or issue that may come up. To summarize, going in well prepared, and be flexible for any issues that may come up is what I would do if I had a short visit"

Ernie S.

Note: if you want to learn more about career and work related topics in clinical research, please visit my website below:
www.clinicalresearchassociatecra.com/

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