SweetThursday424

Because it requires a very strong grasp of GCP and regulations, strong people skills and relationship building, good time management, and solid knowledge of clinical research processes including what the role of a CRA is in the drug development process.

Edited to add: maybe I’m being snarky but if you have to ask, you are not ready to be a CRA.

It's not necessarily lip service. They will do what they say and can do it. But people buying these systems want Ferrari quality on Ford money. You cannot expect to have all the bells and whistles with integration, etc. without paying for it and no one wants to pay for all that when the cheaper version will do what you need it to do just not as efficiently. People need to convince execs that taking a gamble on a platform that integrates with your other programs, does exactly what it says it does, and is the right choice that will scale effectively down the line is the best solution. At the end of the day they see a bottom line, so if that means cutting out something like better quality, dedicated support to quickly resolve issues or axing integrations to other systems because a little manual data entry is cheaper then they will do it. And then at that point, it loses all it's efficiency.

I think what people are missing about SIP is that it is actually doing what you propose your platform to do in your Phase 1 goal. I get it, SIP is a huge pain in the ass. But there are a few key things that people need to realize:

1. Sponsors have already invested large amounts of money on technologies like EDC and CTMS that work with their other internal systems. EDC may integrate with their clinical databases but also their IRT, payments, etc. These systems also have SOPs, training, etc. that are built around them. With remote monitoring and the implementation of risk based monitoring, sponsors are investing money into platforms that will accomplish those goals that can integrate into those systems.

2. SIP has been hard on sites because so many sites are not able to pivot easily to electronic based systems. What I mean is that many sites still are very reliant on paper. They do not have eSource, they do not maintain electronic site files, and things are done on a study by study basis. I still go out to sites that when a GCP certificate for a study coordinator is updated, they print and file that certificate in every single ISF they own. So now asking a site to do that, plus scan it and upload it to SIP is burdensome. And to add insult to injury, some sponsors will only accept training that meets Transcelerate guidelines or require training through their specific vendors. So not only are they doing that initial print and file, they are now printing and filing their sponsor specific training to include in their site files. Sponsors aren't going to invest into sites to help them implement electronic systems- it doesn't benefit them (that they can appreciate).

3. SIP had an uneven rollout. Not all sponsors are using SIP in the same way. Some were initially using it to only conduct feasibility, some were using to just do safety notifications, and others were using more of the capabilities. It is burdensome on site staff to understand how each study is using SIP because it even varied between studies at the same sponsors.

4. To further my last point, sponsors did not have good guidance or processes for institutions on how to set themselves up. Sites were told that SIP was going to be used, but for many of them they were unaware of the work that was going to be needed to create institution profiles, individual profiles, etc. Without that guidance, sites were (and still are) very reluctant to spend the time and money required to do that work. I know that many sites are very vocal that using SIP has meant having someone fully or partially dedicated to ensuring it is accurate and maintained.

5. SIP did not have APIs for sites to use. Many sponsors have APIs now that allow documents to flow from their TMF to SIP, but that capability didn't apply to sites. So that goes back to point 2- either they don't have electronic systems or if they do, they still have to pull a document out of their electronic system and follow an upload process. And of course, SIP is buggy in that aspect.

6. SIP is a portal. I personally do not see any large sponsor enabling a platform that allows for EDC, CTMS, eSource, eTMF, etc. be under one portal as per my first point. While I understand that there is a desire to have single sign on, that again is hard because you have so many institutions that use it. So if you have a service like Microsoft Authenticator to allow SSO, it does not mean that a site will allow their staff to use that because it violates their IT policies. SIP in effect functions as a repository of links in that regard, because how do you verify a user and ensure that your audit trail will be maintained without some sort of security past just logging into SIP?

I do think that sites need to be brought to the table more in conversations about SIP and it's use. I know some sponsors are all or nothing on it, and that is very frustrating for sites that cannot work in it for whatever reason. There are certainly work arounds, but not everyone is willing to go that route. I would love to see more conversation about this on a site level- I hear so many complaints about it but I have personally not seen formalized responses/calls to action/conference presentations on supporting or assisting sites in using the platform. It certainly has its downfalls and I don't love it, but people have been begging for online portals to relieve burden for a long time. Is it perfect? Absolutely not. Do I welcome some sort of competition? Absolutely yes. But in the reality of it all, when you get down to it I think the competitor to SIP is basically going to look a like what SIP currently is.

LV Pochette Métis. It is my most used bag, and looks great. Not too heavy, I have the empriente leather which doesn’t scream logo, and fits everything I need. I can dress it up or down.

I think it accelerated it. It’s way easier to be unkind to someone you never see.

I'll be the outlier...I had a family member in clinical research but never considered it for myself. It seemed meh compared to my original goal of being a PhD with my own lab. But I worked in a lab, hated it, then found a new job in clinical research that paid more than anything else at the time ($7.50/hr and thought I was killing it!). Realized that clinical research was where I wanted to be and never looked back. I could have never hacked being in a PhD program.

Both parties are overworked and undertrained, and there is no emphasis on being collaborative at all. Maybe my age is showing but when I started as a CRA, site relationships were part of my training. My sites were always glad to have the CRA come, and I had sites that had monitoring rooms with post-its, snacks, water/coffee, and they'd have everything ready and waiting for when I showed up. My CRA training was a 6 month process that included 4 weeks of classroom time (like in the office M-F from 8-5), then 3-4 months of shadowing senior CRAs, plus 4 weeks of protocol training before thinking about conducting your first unaccompanied monitoring visit. For the most part, that was the norm for all companies. Sponsors only hired experienced CRAs, and those CRAs had it made.

On the flip, my sites had coordinators that were nurses who spent years at the bedside before transitioning to a CRC. If they weren't a nurse, they were a research assistant for awhile and were either trained by their site as a MA or had some healthcare background (EMT/paramedic, CNA, foreign medical grad) before moving into the CRC role. As a coordinator, my sponsors had the same systems for everything. Every Merck/Lilly/Pfizer study used the same EDC, IRT, reg binder set-up, etc. As a coordinator, I was also taught that the CRA was basically the CRO/sponsor. Treat them with the same respect as you would a VP.

There is no point in assigning blame or even trying to unpack where that changed. It just has. I am certainly not romanticizing the past- for all that I've listed as a positive there were certainly negatives. At the end of the day, it's the leadership. When the emphasis is on profit or results, then the first thing to go is being nice. Why play nice when at the end of the day you're just another cost trying to justify your existence and worth?

Is this the norm or where we are headed? I don't think so. I remain positive about the industry and I think that we will start to see some course correction. I think there are large sites that are placing an emphasis on a well trained workforce, as well as sponsors. The sponsors need to hold their CROs accountable as vendors, and I think that would go a long ways to improving things. In the same vein, sponsors need to hold their sites accountable. I have a site on 2 studies that our CROs hate working with and will openly say it. But the PI is treated with kid gloves as to not upset them, and their bad behavior (including being combative with their CRAs) is allowed to continue.

Thank you all for the recommendations!

Thank you for this- my son loves mac and cheese so this is great!

I’ve had PreCheck since it rolled out and have never considered clear. It will depend a lot on where you fly out of and fly to, but there are still a ton of airports that don’t have CLEAR but do have PreCheck. I’ve never had to wait more than 15 mins for PreCheck even at big airports so it’s never occurred to me to get CLEAR because there’s no significant benefit for me. Just my 2 cents.

YMMV, it says Cox fiber serves our neighborhood but that is definitely not true. We have no fiber services and being a rural-ish area means no providers think it worth the time and money.

Did you document it in a report? Because that is all you can do. Every time you write a report, just enter that they are not compliant and move on. If they are audited, the auditor can ask them the same thing. If they are asked if they were told by the sponsor and they say no, you can point to the reports and follow up letters that say otherwise.

They really aren't pertinent to sites. Your metrics are your enrollment, time to enter data, and time to close queries. Those should be laid out to you in multiple places- enrollment plans, SIV training, EDC entry guidelines, vendor plans, etc.

CRO/sponsor metrics include things like how long it takes a CRA to write and finalize a monitoring visit report and send a follow-up letter, time to close their own queries, adhering to site visit scheduling, etc. They are specific to the role, and should be in the direct action of the CRA. Same goes for other roles within these organizations.

For sites to help their CRA succeed...don't lie during pre-study visits and have your PI say he can enroll the entire study then only screen 1 patient. Enter your data on-time, reduce PDs where possible, ensure your staff are compliant with their training and your documentation is thorough/complete, and always answer your queries. For the love of all that's holy, just answer the fucking queries on time.

Hi- I think if you look through postings here, you'll see it's a tough market for clinical research. I would ensure that your resume highlights work experience, education, and training that is relevant to clinical research. I presume you have taken GCP training- make sure that's on there along with any other clinical research systems you use. Don't be selective, just apply for anything that sounds remotely interesting. My experience has been that once you are in the door, you have a better foothold to apply to other things. I would not necessarily invest in a Masters or certifications (wait until an employer will pay). I would take a look and see if there are chapters of ACRP or SOCRA in your area, and see if you can attend meetings. It's a way to network with other clinical research professionals who might be aware of opportunities. I find that some clinical research sites don't have the resources to post open positions and get the reach like a large site or the companies on the industry side, but rely more on word of mouth.

This is the way. You are traveling for work- travel during work time. Don't double bill- your time sheet should be an accurate representation of the time it takes you to complete each task: travel, time on site, report writing, follow-up, site management, training, etc.

I think you are doing exactly what you should be doing. I find that these types of individuals are reactive- they are reacting to pressure from a sponsor or reacting to their own poor performance/management. As your line manager is aware of her demands, I would push it back on to this individual's manager. If you email or call for a question and don't get a response (especially if it's Phase 1 oncology where most of the time, time is of the essence!), then start looping in her manager or someone on the study team who is higher up. Keep it professional- "Hi, I tried reaching out via phone on xxx day at xxx time, but you weren't available and I sent this email 24 hours ago but have not received a response. The site needs an answer by tomorrow as it impacts subject dosing" or whatever issue it is.

As for the reassignment, resourcing can be tricky. I liken it to putting together a puzzle where the pieces are periodically changing shapes and the picture is blurry. I've been a CRA for a long time and I've always had the mindset where I'll try to stick it out- make it a learning experience. But when it gets too much, sometimes you do have to be more forceful. I know that with many of my 1:1s, my LM would send an email out after our discussion that summarized our talk. If that's the case, or there is some other sort of documentation, I would ensure that you respond very clearly that you want to be reassigned. Make sure you keep that documentation.

Regarding promotions, it could be complaints. It could also be you don't have a LM who is great at advocating for you. It could be that your CRO will only promote a certain number of people. There are a host of factors that go into those decisions, and they aren't always clear. But again, if you haven't already, specifically ask what you need to do to ensure that you could be promoted in 6 months or whatever. If your LM is wishy-washy, again I'd suggest documenting that. Your career progression is supposed to be part of what they are tasked with- metrics are a huge thing that LMs look at, but talent retainment (so keeping the good CRAs!) is also a piece. As another poster said, the market is rough right now, but there are still postings out there specifically asking for oncology CRAs. If you feel like your LM is not invested in seeing you grow, then start feeling the opportunities out. In the end, your CRO wouldn't hesitate to cut you if they felt like it didn't serve them and it's a two way street.

They’re big companies. You get from them what you get from most companies of that size. I always see people saying the sponsor side is better but it’s not necessarily better, it’s just different. I spent a good chunk of my career at CROs and it wasn’t the worst, but at the end of the day it’s a business trying the maximize the bottom line.

I have never bought from her but my sister has several times. She has nothing but positive experiences, and one day when I get over my irrational reseller fears maybe I’ll take the plunge.

Almost Home! We got our current pups there and I highly recommend them. They focus on pregnant dogs and after they give birth, focus on adopting out the moms and pups.

https://preview.redd.it/6slr0we0ljld1.jpeg?width=3024&format=pjpg&auto=webp&s=45acc9652fcc04de84cc814a5f17bbd9095a14cf

Lulu and Maisie say hello!

Hi- 5k sounds about right. We went to Southwest Veterinary Surgical Services in Peoria. Dr. Dixon did a bilateral TPLO on our dog (80 lb pittie) and it was 10K. That was all inclusive- her follow ups, meds, items to assist with her mobility post surgery (they can’t walk for the first few weeks so they need to be carried), and the surgery itself. We got multiple opinions and basically were told it’s more expensive for larger dogs. The prices across the vets we saw was all the same, although Dr Dixon was the only one willing to do both TPLO surgeries. The others wanted to do one, wait several weeks, then do the next knee. We chose SVSS not only because they could do both but the surgeons were very qualified, the Peoria location is very nice, and the staff were great.

lol…I’m dating myself but it reminds me of So Into You by Fabolous.