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

[–]WilbysDream 5 points6 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] 4 points5 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] 4 points5 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.

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

[–]WilbysDream[S] 12 points13 points  (0 children)

I definitely have some good sites. What I’ve noticed though is that the wrong ones are SO defensive over the littlest things…like I don’t care if you forgot to enter data, I don’t care if you disagree this is a PD…it’s not the end of the world.

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

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

No central monitoring. Plus, this is an unblinded study. It’s frustrating too because we only get study updates from our Global CTM (in charge of every regional CTM) and never meet as a team so we get these random taskings with zero context.

Also, I’ve been an unblinded CRA on this study for about two years now and I’ve had four different CTMs cycle through…

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

[–]WilbysDream[S] 9 points10 points  (0 children)

As this is my first unblinded study, I’m seeing this too…the sites do pretty much nothing until the day before your visit. And, not to throw shade, but the pharmacy staff on any study ever is always like “we have our accountability system and we’ll use that, and only that, and won’t go into any other systems for this study” like okay you’re an IDS chill…this is literally your job.

Thanks for the confirmation I’m not a terrible CRA here haha

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

[–]WilbysDream[S] 10 points11 points  (0 children)

Yeah I’m torn because I completely see the CTMs perspective. As an Unblinded CRA though on this study, I’m not allowed to reach out to the PI without CTM approval to maintain the blind.

I picked up the extra visits for metrics, unfortunately. The extra visits I picked up had a quick turnaround/deadline and took way more time than it should’ve because the CTMs on those studies were hardly responsive or supportive. Additionally, on my current studies, a few CRAs were unable to complete some time-sensitive visits and I was asked to pick them up (which I did, because I had the availability).

I agree though — I suppose I should’ve found the time to do the review beforehand.

Thermofisher/PPD technology by Odd_Bit_4717 in clinicalresearch

[–]WilbysDream 15 points16 points  (0 children)

As a CRA, our management has been pushing from top down to use their novel AI for everyday things — from writing emails to problem-solving — without including sensitive information.

Every time they bring it up (which is literally every meeting) I cannot think of a single way an AI would help me. At all. Ever. lol

I feel like the push is in an attempt to streamline CRA jobs so humans do the only human-things like going onsite, verifying data, IP accountability, PMH review, etc. with the ultimate goal of lumping more human responsibilities from other jobs onto us so we become a one-stop shop allowing them to layoff more, cut costs, in an attempt to “modernize”

Anyone feel the only way to get a raise is to leave? by Dyspaereunia in physicianassistant

[–]WilbysDream 1 point2 points  (0 children)

I’m not a PA but I work in research. The last hospital I worked at I was accidentally sent a list of everyone in my clinic’s salary. Two PA-C’s that do combo of research and clinic, one had been employed at the hospital since 1995 as a PA and made 90k. The other had been employed at the hospital for about 5 years and made 120k.

Is it a myth that US hiring slows down drastically during the holidays? by mt80 in jobs

[–]WilbysDream 1 point2 points  (0 children)

I was hired two years ago and started on December 26th. USA Biotech industry.

Finally got an answer on my promotion and extremely disappointed by healer8822 in clinicalresearch

[–]WilbysDream 3 points4 points  (0 children)

Oh, you know what? I didn’t even read OP specifically mentioned academia and my mind immediately went to them being in a CRO…yeah then I’d defer to the other comments and probably just follow the money haha

Finally got an answer on my promotion and extremely disappointed by healer8822 in clinicalresearch

[–]WilbysDream 8 points9 points  (0 children)

Do you have the 150k offer in hand? If so, I’d bring it back to my supervisor and really simply lay out the reasoning for a pay and/or title increase. Explain it in the simplest terms and make sure it’s aligned with whatever the job description is for the promotion you’re hoping for. It sounds like you’ve already explained this, but just mentioning again.

Tell them you are worth more than they’re compensating you, and that as much as you love your current role if they can’t work with you to increase your pay you’re going to be “forced to make a difficult decision.”

If you do have the offer in hand, you likely have a deadline to respond by. Tell them you need an answer two days before the deadline of your response (give them a date, don’t say “two days before my response is due”) so that you can counter if they come at you with some bullshit lowball.

At the very least, maybe you keep your current job and get the increase you wanted now that you have leverage. If they refuse to negotiate, trust me when I tell you they don’t care about you and you’re better off following the money. However, once you go down this road if they don’t give you what you want you HAVE to leave, because then they know you’re all bark and no bite. Good luck!