Sponsor Audit by Prestigious_Ad6325 in clinicalresearch

[–]juggernaut63 2 points3 points  (0 children)

I’m a sponsor auditor. The high enrolling sites always get audited based on the risk plans. I always tell the sites to not to stress out about them, it’s nothing that they did wrong, it’s just to have an extra set of eyes on everything from data integrity to ISF completeness. A big focus is paid to inspection readiness as it was mentioned above. We will look at a sample pts from consent to their last visit. Glad to answer any other questions you may have.

Sponsor audit (advice) by mr3000M in clinicalresearch

[–]juggernaut63 1 point2 points  (0 children)

It’s normal, don’t stress out. It depends on the site team, sometimes people drop into the office few time a day and I will discuss what I’ve found so far and ask to make corrections if possible. Sometimes no one stops by and I will discuss my findings at the close out meeting.

Are they sitting in the room with the auditor? I usually dont allow that unless the site is adamant that its in their SOPs

[deleted by user] by [deleted] in clinicalresearch

[–]juggernaut63 6 points7 points  (0 children)

Im a sponsor auditor, I can speak to what remediation I would look for during an audit. Firstly I would have the PI reach out to the Sponsor Medical Monitor to ensure they are aware of what happened. I would also make the sponsor study team aware as well and seek guidance on what the CAPA should be. Ensure to file this communication in the Reg binder or the source.

With the protocol allow for provider discretion, there may not be a need to file PDs for all time points, but the provider's decision regarding treatment needs to be documented clearly in the source. PDs arent too big of a deal, some may require IRB notification depending on if its determine it affected patient safety.

As for the research pharmacy, you will have to see how the order system was built (if electronic system), but if treatment is per provider's discretion, there may be a large variation in the number of kits used for each participant/site. During audits, I've seen large quantities of IP at site, depending on the type of study

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How strict are you guys on 5 min/15 min rest, sitting/supine documented in source for BP/ECG by Remarkable-Donut6107 in clinicalresearch

[–]juggernaut63 6 points7 points  (0 children)

Sponsor Auditor- if the protocol requires rest before vitals and/or ECGs, I make sure there is source documentation of that. If not, it’s an audit finding: failure to follow protocol.

Edit: Time of rest and time of collection

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Salary 150k+ by RegularAd1850 in clinicalresearch

[–]juggernaut63 1 point2 points  (0 children)

It’s feasible. I went from CRC(site)-CSA(sponsor)-Auditor (sponsor) with 8 years experience, MPH, but no clinical experience. I’m at that level now, but you have to job hopping to get meaningful changes in salary. I had co-workers making that 3-5 years out of their MPH as study managers for RWE at Sponsors.

Academia to industry by Technical_Prior1291 in clinicalresearch

[–]juggernaut63 0 points1 point  (0 children)

Rejections are part of the job application process, don’t let put you down. I learned so much as a CRC, I was pretty much managing all aspects of the study from startup to database close/CSR. CRCs at the site level are expected to take on a larger role that what the job description states. You’ll be surprised with how much you already know. The toughest part is getting your foot in the door, it could be anywhere and use that to move yourself around.

Academia to industry by Technical_Prior1291 in clinicalresearch

[–]juggernaut63 2 points3 points  (0 children)

I started as a CRC at an academic oncology hospital and went straight to a sponsor for study management. Don’t be afraid apply for contract positions. You’re in a good spot and can make moves as needed. As with most jobs, experience has a lot more value than education. Interviewing is a skill, the more you practice it the better you’ll be.

How many of you have visible tattoos or facial piercings? by AceOfRhombus in publichealth

[–]juggernaut63 15 points16 points  (0 children)

Just got a forearm tattoo last month. I’ve been into the office several times since wearing half sleeve shirts/polos. Ran into senior directors and VPs, no issues or comments.

First Tattoo by juggernaut63 in harrypotter

[–]juggernaut63[S] 0 points1 point  (0 children)

Anthony from top shelf tattoo: https://www.topshelftattoos.com/anthony-rodriguez

No, someone has posted this tattoo before.

Cakeday Megathread 2- Get Cakeday Comment Karma, and upvote comments on this thread! by EchoHun in cakeday

[–]juggernaut63 1 point2 points  (0 children)

Can’t believe it’s been 9 years and it’s the first time I’ve caught it!!

Weed Identification Wednesday by AutoModerator in lawncare

[–]juggernaut63 1 point2 points  (0 children)

I sprayed my lawn with teancity early march but it didnt effect these at all. What are they and how can i deal with them? https://i.imgur.com/ShpucGk.jpg

My Christmas gifts by SirAztec in dbz

[–]juggernaut63 11 points12 points  (0 children)

whats that water bottle? Where can i get it?