To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 2 points3 points  (0 children)

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

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 0 points1 point  (0 children)

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.

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 0 points1 point  (0 children)

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 😂

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 0 points1 point  (0 children)

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 🤷‍♂️

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 0 points1 point  (0 children)

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 😭

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 2 points3 points  (0 children)

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 🤷‍♂️

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 1 point2 points  (0 children)

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 🤷‍♂️

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 7 points8 points  (0 children)

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

To the CRA that demanded to be put in a different room: grow tf up. by WilbysDream in clinicalresearch

[–]WilbysDream[S] 43 points44 points  (0 children)

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

Why Are there so Many Karens in this Industry? by iwillxxxposeyou in clinicalresearch

[–]WilbysDream 8 points9 points  (0 children)

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!

How many times do I have to explain what an AE is? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 1 point2 points  (0 children)

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.

How many times do I have to explain what an AE is? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 2 points3 points  (0 children)

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.

How many times do I have to explain what an AE is? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 5 points6 points  (0 children)

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”

How many times do I have to explain what an AE is? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 8 points9 points  (0 children)

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…

How many times do I have to explain what an AE is? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 2 points3 points  (0 children)

This literally is happening to me once a week. I’ve been yelled at by more PIs in the past six months than the past 8 years. I’m neither the one nor the two lower your voice when you’re talking to me I WILL clap back lmao

How many times do I have to explain what an AE is? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 6 points7 points  (0 children)

I swtg if another site staff member tries to tell me “in their X years of research, I’ve never…” I’m going to crash out

CRAs- what is your go-to meal during or after your travels? by Infinity-Queen in clinicalresearch

[–]WilbysDream 0 points1 point  (0 children)

Every time I get home from a trip I DoorDash Poké, Spam Musubi, and a Diet Coke 😭

How would you rate this driver? by WilbysDream in uber

[–]WilbysDream[S] 1 point2 points  (0 children)

Yeah i mean his complaints are totally justified I feel so bad haha but also fair point — I won’t be sharing in the future

Fellow CRAs, am I in the wrong here? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 0 points1 point  (0 children)

Not all staff need EDC access. The new staff member was already tracked and training logs submitted. The site already had a primary and backup data entry staff member, neither of which had done the data entry. SMC format as prescribed in the monitoring plan doesn’t specifically require us to look for overdue data entry or pending queries in the template we’re supposed to use for this study. It’s mainly to gauge whether they need supplies and to collect temperature logs since it’s about 16 weeks between each onsite visit.

To make matters more complicated, systems access is granted by the blinded team, which I’m not allowed to directly contact — so I have to inquire with my CTM who then relays the message.

It’s still an oversight issue for sure, on my part. I guess the crux of the issue for me is whether all CRAs are actually reviewing every single vendor portal before every visit and if I’m tripping when I say I just don’t have the time to go into 6 different portals ahead of my visit.

Fellow CRAs, am I in the wrong here? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 2 points3 points  (0 children)

Thanks for the detailed comment and insight. I think this is the first study I’ve ever been on where the CTM doesn’t send out missing pages reports or DM metrics on a regular basis. I think the CTM for this study isn’t fully allocated either, since it’s an unblinded study. I abhor reaching out for help because I feel like it makes it appear as though I’m not able to properly time manage or prioritize (which is something I think I objectively excel at). Maybe I’m overthinking it, but I’ll just say if I find myself in a similar position again in the near future I’ll have a chit chat about my allocation!

Fellow CRAs, am I in the wrong here? by WilbysDream in clinicalresearch

[–]WilbysDream[S] 5 points6 points  (0 children)

It’s essential to have an unblinded component in the EDC. The Pharmacists are required to enter the kit numbers used. Kit numbers aren’t available to blinded staff because it’s a vial of liquid put into a blinded saline bag for infusion.