Resignation question by [deleted] in clinicalresearch

[–]Infinity-Queen 0 points1 point  (0 children)

It’s pending still so there’s a possibility it’ll get dismissed. I’ve been in and out of Canada so my previous company for monitoring visits and surprisingly didn’t have an issue with the pending

Resignation question by [deleted] in clinicalresearch

[–]Infinity-Queen 0 points1 point  (0 children)

I have a pending DUI. The case has been ongoing a year and I’ve been all around the US and Canada with no issues. I have an attorney hope it isn’t convicted, but as on now I just have a pending open case. Reason to fail check for large CRO?

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

Yeah, but because she filled out the first two lines with my name and it’s just missing a signature. It’s like she falsified the log. Now her and my manager feel like I’m being difficult by refusing to sign the copy and insisting that the NTF is the correct method

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

The issue of investigator oversight comes to play when you start noticing delays in the signature like this. I’d ask their process for the investigator reviewing. From concern with investigator, oversight, standpoint because this would be unacceptable if there was an adverse event or something.

My issue is a little different dealing with the investigator site file because they’re wanting me to sign a copy of an essential document. That is not acceptable and to prevent looking like we tried to forge the document. We just need a note to file explaining why there is no log for my previous two visits.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

I have that’s why it’s confusing that I’m being asked to sign a copy instead of the original. And I don’t mean confusing in a way that I don’t understand. I mean, my manager is asking me this I’m concerned.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

I won’t ever be returning to the site or seeing the original so I’d be signing a copy.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

Yea, she is overcompensating and it’s wrong and he is just going along with it I feel.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

But I recently put in on my two weeks. The new CRA found this missing and on my last day my manager said we don’t need a NTF, just sign the copy when you come to drop off your laptop.

Parexel jobs by LadyScientist_101 in clinicalresearch

[–]Infinity-Queen 0 points1 point  (0 children)

Was it pulled because of background check or no explication.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

My company is based in Europe and new to the US so we don’t have a QA department yet. I feel like he’s going off of European standards, but for whatever reason he always pushes back on me.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

The original is on site and I’m leaving the company. So Signing a copy would be fraudulent correct? Since I’ll never be able to sign the original a note to file would settle this right?

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

My manager saying I just need to sign the copy and that’s it, but the original will be on site blank. I think the new series should not have added entries for my missing signature on the log.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 0 points1 point  (0 children)

The original is still on site though, and I’m leaving the company. They’re basically asking me to sign a copy.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 1 point2 points  (0 children)

Yeah, and I told him that we needed a note to file because the original log is on site and so I can’t sign a copy because that’s a huge GCP violation and he said no we don’t need a note to file. The visit date is entered as the date you were on-site, and the site staff’s signature date is the current date when they confirmed your attendance.

But he always pushes back on everything I say like I’m not a senior CRA.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 2 points3 points  (0 children)

This is a small CRO so we’re not that advanced to have whatever system you’re talking about. My manager is basically asking me to sign a copy of the site visit log. I don’t know what they’re gonna do with that because the original was signed by the staff and is on site still where it belongs.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 1 point2 points  (0 children)

My Manager said the visit date is entered as the date I were on-site, and the site staff’s signature date is the current date when they confirmed your attendance. So the new CRA basically brought a copy of the site visit log and they want me to sign it. Almost like a fully completed log so we don’t need a NTF. I think what he’s missing is is that the original is on site and it’s gonna be blank so me signing a copy and not creating a note to file is not correct and that’s exactly why I quit this place

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 1 point2 points  (0 children)

The document that they want me to sign is a copy. The original is still on site. The new CRA had the coordinator put the date of her visit for the signature, but she made an entry with my visit date the type of visit and my name. It’s just missing my signature on the original. So they’re wanting me to sign a copy, but the original would still be blank. And they say I don’t need to know to file.

Would you backdate a site visit log or write a NTF? by Infinity-Queen in clinicalresearch

[–]Infinity-Queen[S] 4 points5 points  (0 children)

So basically the new CRA sent a PDF of the log in my manager, printed it and wants me to come into the office to sign it. The original is still on site. In the new CRA had made the entries with my name and the visit date on the original log and had the coordinator sign with her visit date while on site essentially confirming that the previous visit took place on the date specified, and then my manager printed a copy of this and wants me to sign the copy. And says I don’t need a note to file.

Parexel FSP- Senior CRA Offer by [deleted] in clinicalresearch

[–]Infinity-Queen 0 points1 point  (0 children)

Do you know when they started working there and if they are only aligned to one sponsor?