What is an average day like for a CRA?

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jameswacker in Seattle, Washington

28 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

28 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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Researcher 1 in Lafayette, Indiana

27 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

22 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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hopefulCRA in Chapel Hill, North Carolina

10 months ago

this forum has been extremely helpful! you all rock!!

im trasitioning from a CRC position in the midst of applying to a CRA position. I've had brief co-monitoring experience so I feel as though I'll be okay in the interviewing process.. but has anyone recently been through the interviewing process and have any questions to share that they can remember?

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SDV-er in Chicago, Illinois

9 months ago

Most interviews now a days ask "tell me about a time...." questions for the whole hour. What you need to do ahead of time is write down at least 25 stories of challenges you faced in the past. Include successes and failures. Never answer an interview question in a general way saying "if I were to encounter a failure, I would do the following" instead you want a specific, authentic story from you past like "the last time I felt like I failed was when I was on this blood pressure study...." Look up the star interview and have stories prepared from your past .

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Phdinwaiting in Sydney, Australia

6 months ago

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

I would also like to know the answer to this question. Is CRA a good path to becoming a clinical research scientist? If not, what are some better stepping stones?

I have a Bpharm and will hopefully have a Phd in 3 months time, I enjoy the research process but don't think that labwork is for me. I'm starting some part time work as a CRC at the hospital where I do my research. Any advice would be much appreciated!

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SDV-er in Chicago, Illinois

6 months ago

A CRA is not a doctoral-level position and is not a stepping stone to get to positions that require PhDs/MDs. If you have a doctorate, pursue doctorate-level careers more in line with your training and experience. Most doctors won't feel fulfilled counting several hundred pills and day and doing paperwork. CRAs follow the scientific decisions, not make them.

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Phdinwaiting in Sydney, Australia

6 months ago

Thanks SDV. That's right. I don't think I will feel intellectually satisfied with the CRA job in the long run. But does anyone know people with Phd's who initially trained as CRAs, and are now clinical research scientists?

If CRA is not a good pathway to becoming a clinical research scientist, then what are some specific positions or titles I should be searching for, as good stepping stones towards this position?

For example, I saw a job ad for a clinical research scientist on Linkedin which required
- Clinical trial experience OR
- Experience in areas relevant to drug discovery OR
- Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)

The job also noted that there were additional criteria needed, if the candidate didn't possess clinical trials experience.
So I'm guessing that CRA would be a good way to obtain such experience.

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SAE4ME in San Jose, California

5 months ago

What SDV-er said is correct, I don't think time spent as a CRA will help you with becoming a clinical research scientist. As a CRA you'll learn two things: how to be a CRA, how to manage several CRAs, & how to manage several people who manage CRAs (Ok maybe that's three things). My background is different from yours however I'm finding the skills picked up during my time spent as a CRA are counting for zero towards anything other than what I mentioned.

I would take a look at pharmas, especially startups, whose drug development pipelines & drug discovery process are closely aligned with your personal research interests & expertise. I'm not sure whether it's the same in industry as it is in allied health for PhDs, are post-docs a thing with pharmas? If so that seems to be the obvious choice. When I worked on the manufacturing side of pharma before I landed at a CRO, I think they were called research fellows. A post-doc/fellowship model seems to bridge the gap between academic training & industry, & provide the experience you described. Also, as with any PhD, the more grant money & publications you can hook to your name, the better off you will be. Start-ups especially will pay close attention to that.

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Phdinwaiting in Sydney, Australia

5 months ago

SAE4ME, just to clarify, you're talking about clinical research scientist, and not research scientist positions?

It seems to me that there are a number of Research Scientist or Scientist I positions available in industry for post-docs (and sometimes for freshly minted PhDs), but that these are all lab based.

I would like to start moving away from the labwork, ideally. My PhD is in medical science/molecular biology so it is basically all labwork, despite my undergraduate training being in allied health (pharmacy).

That's why I'm interested in clinical research scientist positions, as it seems that they encompass the scientific aspects, without being lab-based. It seems like if CRA is not the way to go, then perhaps bench scientist, medical affairs or 'clinical development' (though I'm still a bit unclear what exactly that is) are better transition points.

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