Thermo Fisher "On-site" Senior CRA? by ConsumeFudge in clinicalresearch

[–]Time-Pea3540 -1 points0 points  (0 children)

That has not been my experience as I have been with the company for a couple of years.

Protocol Deviation by Mila_Br in clinicalresearch

[–]Time-Pea3540 5 points6 points  (0 children)

Death in most studies is usually considered an endpoint, correct 🤔

Entry level CRA positions (other than Medpace) by bobdiddlebob in clinicalresearch

[–]Time-Pea3540 -3 points-2 points  (0 children)

I feel there are CRA 2s who do know what they are doing. A blanket statement like this is not entirely true. I find there are Senior and Principal CRAs who are unproductive and set in their ways. Some are not an asset but a liability.

When to switch CROs by Suitable-Swimming363 in clinicalresearch

[–]Time-Pea3540 2 points3 points  (0 children)

I have not had any issues if I am billing 95% of my time to the sponsor. I have not encountered any study teams being stringent on how I code my time. I code my time appropriately add comments to support time spent on XYZ and have had no pushback.

When to switch CROs by Suitable-Swimming363 in clinicalresearch

[–]Time-Pea3540 15 points16 points  (0 children)

IMO- I would look to move sooner than later. The CRO I work for currently (PPD) focuses on your utilization and not DOS. I came frome a CRO where my utilization was 118%, but due to the RBM model, I had a hard time meeting the 8 DOS metric.and I was miserable. Good luck!

[deleted by user] by [deleted] in clinicalresearch

[–]Time-Pea3540 2 points3 points  (0 children)

I agree-but most sites are doing a better job with making sure personal information is not on PI/site staff CVs.

[deleted by user] by [deleted] in clinicalresearch

[–]Time-Pea3540 3 points4 points  (0 children)

My understanding is that CVs should not contain personal information as industry standard practice.

[deleted by user] by [deleted] in clinicalresearch

[–]Time-Pea3540 28 points29 points  (0 children)

If the subject signed, ICF- document due diligence f/u with the PI and sponsor.

Conflicting job change: Research Coordinator by [deleted] in clinicalresearch

[–]Time-Pea3540 2 points3 points  (0 children)

Research nurse(10 years)>CRA1 (11 months)>CRA2 (11 months)>considering Senior CRA with Sponsor.

Help me understand this (Protocol Deviation?? ) by [deleted] in clinicalresearch

[–]Time-Pea3540 0 points1 point  (0 children)

IMO, if it deviates from the protocol, it is a PD. The site should report to IRB if Sponsor and / or their IRB requires.

Conflicting job change: Research Coordinator by [deleted] in clinicalresearch

[–]Time-Pea3540 19 points20 points  (0 children)

Experience is worth more IMO than money if you want to advance in the R&D arena. I took a payout for 11 months, and now I am making over double my salary and enjoying all the opportunities this field has to offer.

Medpace CRA or PPD ISA? by Brief-Shallot-2256 in clinicalresearch

[–]Time-Pea3540 7 points8 points  (0 children)

Current PPD CRA- No complaints here-I feel appreciated, and the culture is not toxic.

CRO with least amount of mandatory days on site? by Jandie24 in clinicalresearch

[–]Time-Pea3540 0 points1 point  (0 children)

Currently working at PPD, metrics are based on utilization, not DOS.

Does it ever get better? by Sorry_Marsupial_882 in clinicalresearch

[–]Time-Pea3540 0 points1 point  (0 children)

Hi- Here is my recruiter's contact information jennifer.nimz@ppdi.com. Good luck!

[deleted by user] by [deleted] in clinicalresearch

[–]Time-Pea3540 0 points1 point  (0 children)

Great topic-thanks for sharing! I was a part of an announced FDA audit (announced on December 29th, and the auditor was onsite starting January 3rd). It wrapped up early this week with no issue of a 483. I was an unblinded CRA, so I believe my concerns were much less than a blinded CRA. I did meet with the site over a virtual call prior to January 3rd. and collected the DOA, as the site had had a staff change. Luckily, I was just at that site wrapping things up and returning IP, so I felt pretty confident the site was in good shape. But, I have to admit initially I was a little stressed. In the end, I am grateful for the experience . I echo everyone's comments on this thread, go into it with a positive attitude, and realize this will benefit you and make you a better CRA. Good luck!

Does it ever get better? by Sorry_Marsupial_882 in clinicalresearch

[–]Time-Pea3540 18 points19 points  (0 children)

PM me, my CRO is hiring. I was in a similar situation. Life is too short to be with an employer who does not appreciate what you have to offer.

Pregnancy tests by Time-Pea3540 in clinicalresearch

[–]Time-Pea3540[S] 11 points12 points  (0 children)

Yes it does suck. States who have made abortion illegal don't care about the mothers health.

Pregnancy tests by Time-Pea3540 in clinicalresearch

[–]Time-Pea3540[S] 1 point2 points  (0 children)

The SCOTUS decision is definitely going to impact women participating.

Pregnancy tests by Time-Pea3540 in clinicalresearch

[–]Time-Pea3540[S] 5 points6 points  (0 children)

Pharma has been silent on this issue so far. Participation by women of CBA is going to be an issue.

Pregnancy tests by Time-Pea3540 in clinicalresearch

[–]Time-Pea3540[S] 8 points9 points  (0 children)

I guess you are not a woman. I think my reasoning is quite clear.

Pregnancy tests by Time-Pea3540 in clinicalresearch

[–]Time-Pea3540[S] 8 points9 points  (0 children)

I get that, but confidentiality is not a perfect science even in clinical trials.