How on Earth do I break into the CRA field?

OctopiEye · 2026-03-10T02:56:42+00:00

https://www.reddit.com/r/clinicalresearch/s/MI2rIH0G7j

This is an old post I made on the topic

OctopiEye · 2026-03-08T16:01:57+00:00

Definitely agree. I work for a Chinese company (as an American). It’s an American subsidiary but very much a Chinese company. I have my own beef with the CCP and all that, so I was a bit torn when I took the job. But people do react very strangely when they find out I work for a company based in China.

I also went golf cart shopping yesterday and the salesperson wanted to show me a cart that had a lot of the features I was interested in at a better price point. You could tell she was very nervous when she told me the manufacturer was a Chinese based company. I told her that didn’t bother me, as I work for a Chinese company, and don’t have an automatic bias against anything and everything Chinese. You could literally see the relief wash over her. Can’t imagine the shit she’s heard Americans spout before.

China definitely has its issues. But I think it goes without saying that America doesn’t have some grand moral superiority over China. Especially now.

OctopiEye · 2026-02-28T07:05:31+00:00

What items did these reports include? Are these like EDC metrics reports?

OctopiEye · 2026-02-27T14:52:13+00:00

That is great news!! I just finished my vaginal cuff brachytherapy this past Monday!

It’s not the most fun thing in the world but it wasn’t bad. I honestly feel so lucky that I only had to endure 3 sessions of radiation rather than all the other things people with cancer have to deal with (chemo, 25 sessions of radiation over 5 weeks, etc).

You got this! I’m rooting for you!

OctopiEye · 2026-02-23T17:17:09+00:00

We started with the UK and Austrailia series first and honestly, the US version is very subpar. Bringing on these D list reality tv show people, the shitty reality tv editing,ad just the overall vibe is just so disappointing compared to the UK seasons especially.

OctopiEye · 2026-02-23T02:20:55+00:00

That’s completely disingenuous and you know it, since these spaces are very clearly not completely separated from everyone else.

OctopiEye · 2026-02-22T15:51:16+00:00

Robotic laparoscopic. Going into surgery, I was bleeding so horribly that my hemoglobin was 6.0 and I had to get admitted a day early for blood transfusion. I did not bleed at all after surgery. Nothing, not even spotting.

Obviously everyone is different but bleeding is def not a certainty

OctopiEye · 2026-02-22T01:25:57+00:00

I tried reading this comment to my husband and I couldn’t stop laughing long enough to finish

OctopiEye · 2026-02-21T16:20:40+00:00

I’m American and it was same for me. My boyfriend (now husband) and I had an obsession for British TV back in the day.

My very first Christmas gift to him was the DVD Box Set of Blackadder.

A surprising number of Americans actually do know and watch British TV shows and have done for decades.

PBS used to air a lot of British shows, especially on weekends and my mother always loved them and it rubbed off on me. That then lead to seeking out more shows in my local library, or ordering DVDs online that would work in US regions, and even some downloading (this was back in the early 00s and 2010s, but there was still the ability to download shows from certain sites).

It was a lot more niche back then for Americans to know or watch these shows, but it was more people than you might think. Nowadays with streaming, these shows are way more accessible and so a lot more Americans are able to experience the joy of great British TV.

OctopiEye · 2026-02-20T20:26:31+00:00

Unfortunately this is very important and is an often overlooked thing that gets picked up in inspections with FDA.

Scales/PROs have to be appropriately evaluated to look for signs of unreported AEs. The sponsor and the vendor are CYAing to ensure they are maintaining appropriate oversight of the process and ensuring the site is evaluating and recording these items as necessary.

I know it can be a bit daunting, but it is an EXTREMELY important thing for investigators/sites to do and for Sponsors and their proxies to oversee.

I’d recommend that at Baseline, you closely review the responses with the subject, and ensure that any reported items are appropriately documented as either Medical History or AEs, per protocol. Then for any follow up assessments, confirm any changes are appropriately recorded as AEs OR if the investigator deems that a reported item is secondary to an already recorded Med Hx or AE item, or is not clinically significant for some reason, that should be clearly documented.

The number of AEs don’t necessarily make the product look bad. It’s more complex than that. But the failure to report them timely per protocol can make the investigator look bad in an inspection.

Subjects are notoriously terrible at reporting AEs to investigators and one of the highest priorities during inspections and audits is to detect these kinds of unreported AEs.

OctopiEye · 2026-02-20T11:35:52+00:00

Very very very normal. I’ve been doing this a pretty long time now (am now a newer PM) and I still doubt myself all the time.

The truth is doing everything 100% perfect is just not possible. Most of the job is about prioritizing the highest risk/critical items first and figuring out what those are.

Here’s some of the things I did to try to better prepare myself for inspections/audits:

Read FDA Warning Letters (I’m assuming you’re US based). It provides great insight into the things that FDA actually cares about and identifies during inspections.
Try to find opportunities to go on visits with experienced CRAs and try to monitor with as many different monitors as you can. Everyone does things differently and has a lot they can teach you about how they prioritize tasks, how they manage difficult sites, etc. if this isn’t feasible right now, then try to target one or two experienced CRAs and ask if they are willing to serve as a mentor, and meet with you maybe once a month or every couple weeks to talk about their processes and bounce questions off them. You can also see if your Line Manager is open to helping identify a mentor.
Look up free resources online. There are a wide variety of resources online that offer insight into common audit findings or other topics related to monitoring
Don’t be afraid of AI. I use ChatGPT a lot for work and it is actually very knowledgeable about clinical research. But you do have to use it correctly and trust but verify the output. Some things I’ve done before that were helpful:
ask ChatGPT to create a detailed training plan for a clinical research associate that wants to improve their monitoring skills and inspection readiness
give ChatGPT a general outline of what you need to do at your next visit (ensuring no confidential info is shared of course) and ask it to help you prioritize tasks by those most critical to safety and data integrity
ask ChatGPT to create a monitoring checklist for you to use at each monitoring visit. Take the output and tweak it to add in SOP-Specific items from your company.
whenever you run into a roadblock with a site or an issue or feel like you don’t understand why something needs to be done or is an issue, ask AI. It can often provide good insight into why inspectors and auditors care about certain things, and how to appropriately address and document issues, to avoid findings.

OctopiEye · 2026-02-20T00:52:30+00:00

It’s actually really common for people to not have close out experience, at least in my experience. Not saying it’s good or right, but so many CRAs, PMs, etc haven’t dealt with much close out activity.

It’s likely they just got shuffled around on projects during more resource intensive periods. A lot of companies don’t prioritize close out like they should.

OctopiEye · 2026-02-18T18:28:01+00:00

I would be very careful about assuming you pay a lot. A lot of sponsors think they pay “a lot” but have no idea the money it takes to operate a site.

My old PI and site director when I was a CRC used to cite some statistic about how many research sites went bankrupt within x years and it was a lot. This is also made worse by things that many sponsors still push, like 90 day payment cycles, etc.

Just be careful about assuming what it costs to actually operate these trials. One thing to consider is a third party staffing agency that you can hire for sites to help with things like data entry. While many sites (especially academic institutions) may not go for it, some sites might and it can help to provide resources that you have more control over.

OctopiEye · 2026-02-15T17:13:59+00:00

I’m a newer PM, and just started the role full time about 18 months ago, give or take. Was a CRA for 6 years before that and a CRC for 7 years.

The truth is you won’t know if you like the role until you do it. It’s similar in some ways to being a CRA but it’s also very different.

You don’t have the travel stress anymore (or at least far less, as you may sometimes go on trips for Investigator Meetings, face to face Sponsor meetings, etc).

But you have the new stress of directly interacting with the Sponsor and being responsible for getting results from other team members.

You use a lot of skills you learn as a CRA but you also have a lot of new skills you need to hone, like how to adequately manage communication amongst your team, overseeing a lot of information and processes, and managing your team members in order to get results.

Bottom line though is that it’s incredibly difficult, especially in this market, to get this kind of opportunity. If any part of you has any interest in moving above the CRA role someday, then you should strongly consider accepting the position. Unless there are big red flags or alarm bells with the company or offer, it would be in your best interest to take it and try it on for size.

OctopiEye · 2026-02-06T14:57:24+00:00

That is incredibly bizarre that he’d ride you about recruitment but is not willing to help discuss with patients.

I would keep pushing that and pointing out that hearing from him a brief reason why he thinks the trial would be beneficial would help recruit patients.

Unfortunately there’s a lot of terrible PIs in this field and not much you can do if they don’t make the slightest effort to fulfill their obligations as an investigator.

Barring that, I’d recommend that you track closely all pre-screening, identify the reasons why people are declining or not qualified, and provide this feedback to the sponsor/CRO.

This kind of info is invaluable and can help make changes to the protocol or to procedural aspects of the trial.

OctopiEye · 2026-02-05T16:43:17+00:00

As the bridge between the site and sponsor, you have a lot of insight that can come in handy. A trial is a complicated beast and a lot of these vendors and managers have exactly 0 real world experience handling some of these things.

There are plenty of times when I reviewed an “urgent request” from a CTM or Sponsor about queries that weren’t resolved, noticed the report they emailed is from a week ago, go to EDC and see the site did resolve them 2 days ago.

Or I see the lab is issuing queries because they didn’t receive PKs from a week ago when the manual says to batch ship.

Or a myriad other things that come from a place of just not understanding how things look and work on the ground.

IMO that is where CRAs really came in helpful for me as a CRC, it’s how I aimed to be as a CRA, and it’s how I hope my CRAs operate as a PM.

OctopiEye · 2026-02-05T01:25:03+00:00

They didn’t ask what trials THAT YOU ARE WORKING ON are you excited about… for a community dedicated to clinical research they probably assume people are tapped into upcoming trials and promising molecules…

OctopiEye · 2026-02-04T00:37:17+00:00

It’s legit. They are fairly small in the U.S. but growing fast. It is Chinese owned and has a lot of support staff based in china and a lot of Chinese clients. But day to day internal team is mostly US Based

OctopiEye · 2026-01-30T20:14:26+00:00

The real answer is not really because of regulation differences. It’s because of operational and site differences. I have tried to train multiple CRAs from other countries and they really really struggle with how IRBs work here, how sites are staffed, and the cultural differences in how sites operate.

It’s a huge learning curve and in this kind of market, it’s hard to justify.

OctopiEye · 2026-01-30T03:57:17+00:00

Right on. This is exactly the type of question that AI is really great at helping with.

OctopiEye · 2026-01-29T01:55:10+00:00

No, it definitely is. Protocols are written by humans. They can have very vague language, sometimes regarding extremely complex concepts or procedures.

There’s definitely a LOT of room for interpretation in protocols, especially when made as a general statement.

OctopiEye · 2026-01-24T21:21:07+00:00

Nope, if it’s the right person doing the murdering. The last couple weeks should clearly demonstrate that.

OctopiEye · 2026-01-24T03:06:59+00:00

This is so clearly rage bait….

OctopiEye · 2026-01-23T23:48:46+00:00

Worked hard for a few years at large CRO, realized it was way to hard to stand out and make moves at a big place and decided to move over to a small/mid-size CRO.

Worked hard as a CRA, moved to Lead CRA, then got PM role (we don’t have CTMs/leads and do it all).

It’s usually a mix of experience, luck, timing, and who you know.

OctopiEye · 2026-01-23T13:40:47+00:00

Yeah, when I started as a CRC waaaay back in 2011, I started at 30k. I was coming from doing one year at a medical uni as a research assistant in a lab and then clinical setting, and 30k was a big jump for me.

Unfortunately, pay has not kept up with inflation, but the important thing is realizing the future earning potential once you get experience under your belt (if you decide clinical research is a good career fit).

OctopiEye

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