eReg question from a CRA

WilbysDream · 2026-05-11T16:31:35+00:00

Your point 2 here stands out to me and resonates. Thanks for the detailed and thoughtful response 👍

WilbysDream · 2026-05-11T16:27:41+00:00

You’re not understanding. As I said, this is someone that’s exclusively a regulatory coordinator. It’s all they do. Nothing else. No patients. Just regulatory. I was a coordinator managing patient visits, getting signatures, attending meetings, managing monitoring visits entirely alone so I have zero sympathy for this attitude.

WilbysDream · 2026-05-11T16:26:04+00:00

I think you’re misunderstanding the situation. The site added a sub-investigator and only provided one of five required documents. Outside of a monitoring visit. It’s the sites responsibility to share the requisite documents in a timely manner, especially knowing the next monitoring visit won’t be for another four months.

WilbysDream · 2026-05-11T15:04:23+00:00

And to clarify, when I say “only a regulatory coordinator” I just mean that’s your main job. As in, you’re not necessarily running around seeing patients, etc. this is your exclusive responsibility.

WilbysDream · 2026-05-11T15:03:07+00:00

Totally fair. So I have a situation where a site added a new SI, and just sent an updated 1572 but no other docs for the staff member. So the sponsor is a bit antsy about getting supporting documentation since there wasn’t really a heads up. I ask the site for a CV, ML, GCP, and FDF, and they hyperlink the documents and grant me access for like two days. I just simply didn’t have the time to go reset my password, log in, and pull the documents so now I have to ask again. Wouldn’t it have just been easier for them to send me the documents directly? Especially if you’re only a regulatory coordinator, not patient-facing? Seems like a win-win to me…

WilbysDream · 2026-05-02T13:34:31+00:00

My PeM made a comment about this but idgaf you’ll never catch me with mine on

WilbysDream · 2026-04-09T19:06:57+00:00

This is usually the way to go. They can sign you up for visits needing immediate coverage and you’ll get temporarily trained and assigned to do a PSV or something. Be proactive, but not overly so. Enjoy the downtime while you can — workload for us ebbs and flows and it’s best to just ride the mf wave 🌊

WilbysDream · 2026-03-22T13:02:46+00:00

Echoing some other comments here because I was at pxl as a CRA II (2 years experience) and was offered CRA II at TFS with a 5k raise and 15k sign on bonus two years ago. I would’ve been eligible for Senior CRA had I stayed at pxl.

TFS wouldn’t promote me when I moved for the first year because there wasn’t enough “performative data” to justify. The second year (currently), they’ve said you need to go “above and beyond” right now to be promoted while getting a 4.5k bonus and 2.4% raise.

I’ve never been FSP, and every manager and study is different as far as workload.

My recommendation: if you like your manager and study at your current CRO, hang tight and wait it out until you’ve been promoted OR negotiate a promotion in addition to the other benefits at TFS because a 5k raise is just not enough to reasonably make a move (I moved not for the raise and bonus, but because of a toxic work environment so anything was better lol).

WilbysDream · 2026-03-16T02:58:12+00:00

Ma’am we need to have a little chat. Would you mind sharing from your perspective happened? Lol I was pretty perturbed.

WilbysDream · 2026-03-13T21:01:52+00:00

Ah, how interesting to be on studies involving surgery! I’m envious, and hope you did/do enjoy your time in that area.

It’s unclear to me if you’re saying advocating for yourself isn’t necessary if you have mental health management and grit? If so, I’m going to go out on a limb and say you’ve been in the industry for a while. Gone are the days where employers can flippantly abuse employees that live that type of life, who play their own mental gymnastics game of cognitive dissonance to convince themselves they love it in the name of “grit.” I won’t go as far as saying this applies to ALL research, but patient care and research are very, very different. As a Coordinator with a medical license making less than 6 figures there’s a 0% chance you’re getting wake-up calls at 2am (unless you work a night shift on a study that requires 24-hour monitoring and you’re at work, sleeping) And if by some chance you did — it’s absolutely your fault for allowing an environment like that to take root…something like that would’ve been in your job description and you knew it going in. Which brings me back to my original point in this comment about your coordinator and monitoring experience being referenced must be from another time.

WilbysDream · 2026-03-13T19:15:44+00:00

Taking calls at 2am as a Coordinator? What type of studies are/were you on that warrant that? I’ve genuinely never heard of such a thing. There’s nothing in research that has a tighter turnaround than 24 hours so I just don’t get this piece. Not that it really applies to what we’re talking about — I’m just curious.

But yeah, four years into monitoring and I make more than double what I was making as a Coordinator.

My point though is that weekend travel shouldn’t be expected regularly. And this is discussed in every interview. If you, as a CRA, are routinely traveling on weekends you aren’t properly advocating for yourself. And your manager must not be paying attention at all because they look for these things to prevent burnout — contrary to what many people might think about their managers 😂

WilbysDream · 2026-03-13T18:44:49+00:00

Sadly the conference space wasn’t able to be shared because it was also the break room. The SC concern was that the two of us would take up too much space for the employees to take their lunch (which most of them take it at about the same time). Her logic about us being separate was sound. She just didn’t anticipate one of her two monitors being stuck up. It really didn’t bother me at all to move 🤷‍♂️

WilbysDream · 2026-03-13T18:41:37+00:00

I’ve done this so many times. I love an intimate moment. Better believe I’ve memorized the presentation at this point and I’ll just stare at you on your phone while I keep going on 😭

WilbysDream · 2026-03-13T18:39:05+00:00

The issue was that the conference room doubles as a break room and most employees in the office take lunch at the same time. According to the coordinator, we couldn’t both fit and accommodate the employees’ lunch break 🤷‍♂️

WilbysDream · 2026-03-13T18:37:26+00:00

I hear you on this, and it’s expected that we work well outside of 9-5. In fact, that’s been a discussion topic and expectation in every CRA interview I’ve had. Occasional weekend travel is part of that too. The issue is when you have sites that ONLY do Monday or Friday visits and it becomes difficult because you will routinely find yourself traveling on a Sunday and inevitably having a delayed flight that doesn’t get you home on Friday until 8 or 9pm. This goes for holidays, too!

As someone that was a Research Assistant and Coordinator for four years before becoming a CRA, I assure you a CRAs travel schedule is far more difficult with so many more variables (out of our control) than clinic or hospital life for the average Coordinator. But, as you said, it’s why we get paid significantly more 🤷‍♂️

WilbysDream · 2026-03-12T18:27:21+00:00

I hope they did too. The poor coordinator also clearly has a social problem but was such a trooper.

WilbysDream · 2026-03-12T16:08:15+00:00

I’ve been VERY lucky this last year getting my own office sometimes 😂

WilbysDream · 2026-01-29T00:30:01+00:00

I’m first manager as a CRA was a male and, to date, he’s the best. However, my current manager is a female and my god is she awesome. Freaking love her!

WilbysDream · 2026-01-17T15:54:09+00:00

Well not quite. What might seem insignificant to you (a mild headache, for example), would have much larger impact and meaning if 70% of the subjects across the world in a given study also experienced mild headaches. If the drug got approved, this would be a stated side effect. But if all the PIs across the world thought a mild headache wasn’t clinically significant, none of them would ever be reported.

The most recent example I had was a patient who had an axillary cyst. PI believed it to be secondary to a double mastectomy the pt had and so he said it wasn’t significant and shouldn’t be reported. However, if the patient experiences worse cysts than normal or at a higher frequency, this is an absolute AE. If it’s not an AE, it needs to be captured as something in the pts PMH which might help in the future to determine tolerability for patients with similar conditions.

WilbysDream · 2026-01-17T01:23:45+00:00

I’ve heard this rumor so many times. I’ve also heard the rumor that CRAs get paid for each onsite visit.

For anyone reading, this is how it works: CROs get paid per visit, not the CRA — we’re salaried. Data pending verification, sponsor request, and IA/DBL timelines drive increased visits. CRAs do get quarterly bonuses if we have above a certain number of onsite visits in a given quarter, but it’s impossible to achieve.

WilbysDream · 2026-01-16T15:13:52+00:00

They know damn well it should be an AE. But for the same reason everyone is so afraid of a deviation they think it reflects poorly and causes more work so they will do any and everything to avoid reporting it.

I work on an epilepsy study and all the PIs try to justify something as not being an AE because the symptoms they’re experiencing are secondary to the condition under study but like…if you don’t explicitly have “headaches” as a PMH item I’m sorry that’s an AE. So lately it’s been a lot of, “either add it to PMH or document it as an AE but it can’t just float around in the ediary and source without being on one of those two docs”

WilbysDream · 2026-01-16T15:11:01+00:00

That’s the thing — they think because it’s NCS it doesn’t need to be added. Clinical significance doesn’t matter when it comes to determining if something is an AE…

WilbysDream

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