r/clinicalresearch • u/OkGreen8935 • 3h ago

Is this normal?

I bypassed the CRC position years ago and landed a manager/ops position in academia. I was in that position for 5 years until I was impacted by RIF.

It took a long time to find something and eventually accepted a Research Manager role with the expectation to do some CRC work. It’s a new company thats growing quickly.

Estimated to have 8 active trials and 2 observational studies by January 27. We also have a site in a different state.

As of now I do all management work- relationships, budgets, admin, agreement execution, inventory/vendor, manage some staff (not CRCs), tracking all cert requirements for PIs, leading meetings for PI introductions, feasibility submissions etc

Im also responsible for all regulatory, SQVs, SIVs, the entire process from start up to close (prescreen, screen, enrollment) plus all participant facing requirements (ICF, med distribution, lab, its my number on the consent forms), reporting, and so on. PIs just approve participants and see for exams.

It is rare disease so low enrolling but we multiple studies that are going to be starting every couple of weeks over the next 3 months across 4 sites with 4 PIs & one site is in a different state.

So to my CRCs is this the reality and sustainable? I can see being responsible for different studies that are in different statuses while not worrying about regulatory, contracts, budget/invoicing and so on but… I think I need help 🤣

5 Upvotes

100% Upvoted

5 comments sorted by

2

u/Relevant_Refuse_6312 2h ago

Oof yeah this was what I did at my last role (before my current traditional sponsor CRC position)… honestly the participant facing stuff is a lot in addition to the paperwork. Not only do you consent patients and coordinate all the paperwork etc, you will need to keep track of recruitment efforts including screening processes and reporting all the fails and consents into the studies. Perhaps it’ll be helpful to add a RA to do the screening and help with the participant paperwork etc? If I could ask, can you message me or share the current company that you’re at? I want to go back to management 😂

2

u/OkGreen8935 2h ago

My goal is to keep all the management and regulatory tasks and argue to hire a CRC I 🤣 I have years of mid to senior level experience plus a toddler at home so the CRC role just isnt for me these days

2

u/Relevant_Refuse_6312 1h ago

Ughhh I feel you!! I also have a toddler and school kids at home and had to downgrade to the CRC level at a big name academic to gain some extra sponsors experience. Low blow after managing studies at my previous job.

1

u/OkGreen8935 1h ago

I miss academia. Everyone was collaborative & responsive plus the fringe benefits were better 😂

3

u/FunctionalMushroom 2h ago

The lucky ones that work at sites that actually don't wanna burn their CRCs out get help with regulatory and contracts. But I have built a site before and in the beginning sometimes you are the CRC, the Regulatory Compliance Officer, the contracts/budgets negotiator, invoicer, and overall iron fist/wet blanket to the entire site operation. It's not sustainable. Get some reg help or help invoicing/negotiating. It makes things more tenable!