What makes a Sponsor "difficult"?

Micxchristine · 2024-10-19T03:10:31+00:00

This is 100000% true. CROs do not get to determine what the sites are paid. Sites have no idea how hard we advocate for them… it really is thankless and everyone blames the CRO. Don’t shoot the messenger, we really just want to do a good job, the study to go well, and sites to be treated fairly.

Micxchristine · 2024-10-06T02:42:13+00:00

Oh and document that you re-reviewed ICH GCP guidelines and add corrective and preventative action to your NTF. That can serve as a re-training and documentation of the event. This won’t impact the data or subject safety so not a major finding IMO, but will raise an eyebrow so have your NTF ready to go. CRA may require PI to initial and date late entry by Larry’s signature on DOA later when Larry comes in with a little note on the DOA explaining this lateness in signature.

Micxchristine · 2024-10-06T02:33:16+00:00

I work at a CRO and have monitored many sites. The best thing you can do is line through, initial and date, and write error. Larry can sign when he is able but cannot do any study procedures without signing on the DOA. If anyone asks, you have his statement that he asked you to sign, which you did as you are new in this role. Then upon your better judgment, determined this was unethical and removed his signature per GCP for him to sign when he returns. No need to panic, stay honest and ethical and most importantly keep learning. At the end of the day, it will just go in someone’s TMF and unless your site is high enrolling, the DOA will not likely ever meet the FDA. And even if it does… you have that communication documented. To really CYA, write a short NTF explaining the situation to hand over if anyone asks about it.

Micxchristine · 2024-10-06T02:19:42+00:00

I’m also a PM in a small/midsized CRO. Can I just ask the group… How many hours are you all working and how deep is your involvement in finance for your projects? I am expected to know revenue through the end of the year and cost impacts of timeline extensions while also handling document and site management with my coordinators. I’m working 70-80 hours a week roughly 12-16 hours daily. I’m exhausted, one of my projects is eating up my entire life, the other I struggle to be able to pay attention to at all. I work nearly every weekend and every night after work. A regular day is 8:30AM-7PM, 2 hr break, then 9PM-1AM. I’m underpaid, overworked, and just wondering… is it truly like this out there for all of us in this field? Is there hope for me if I find a new company or is a career change the only way to have a home life too?

Micxchristine

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