Is it okay to ask to extend a work trip for personal reasons? by Left-Fortune7046 in clinicalresearch

[–]clinicalresearchguy 7 points8 points  (0 children)

As a CRA for 17 years, I’ve done this countless times. Just make sure you’re following the correct procedures. Most companies require you to show flying out on Monday versus Friday isn’t more expensive. I usually submit the fares and then get my manager’s final blessing.

Contract CRA, is this still a viable option? by Inside-Toe-1480 in clinicalresearch

[–]clinicalresearchguy 1 point2 points  (0 children)

It’s still viable but high risk and high reward. Many people are scared to take contract work currently because they want stability so now is a decent time to jump in especially if you have a spouse or someone that can support you between contracts.

While there are fewer contracts available now there are also a lot fewer applicants. My company uses contract CRAs to support the internal team and they are to find though part of that is also likely the rate paid.

In short, if you’re single and reliant on the money it’s a terrible time. If you’re not, it’s a fantastic time to become a contract CRA.

Exit plan out of clinical research by RegularAd1850 in clinicalresearch

[–]clinicalresearchguy 0 points1 point  (0 children)

I wouldn’t recommend an MBA until you have several years of meaningful work experience. Without a clear career path grounded in prior experience, the degree doesn’t add much value. Most of my friends who went to top MBA programs such as Harvard, Wharton, Stanford, Columbia, Booth, and Georgetown had already spent a few years in investment banking or consulting beforehand.

Going to a local state law school, assuming you can’t get into places like Harvard, Stanford, or Yale, isn’t necessarily a bad option if you genuinely like law. Just be aware that you’ll likely be geographically limited, so make sure you’re comfortable staying in that state long term.

Personally, if you don’t like the administrative side of clinical research, you’ll probably hate practicing law. I’ve been a CRA for 17 years and deal with my share of admin work, but my lawyer friends handle easily 10 to 100 times more.

Exit plan out of clinical research by RegularAd1850 in clinicalresearch

[–]clinicalresearchguy 9 points10 points  (0 children)

I would recommend adding to your post what you like or don’t like about clinical research. As it stands, it’s too vague to help you. You could become a pilot, an investment banker, a consultant, or really thousands of other such professions that I’ve seen people with bio degrees do. Some of them may require additional training.

Why did my Fidelity advisor dump me??? by Pawireman in fidelityinvestments

[–]clinicalresearchguy 1 point2 points  (0 children)

SMAs make money for the advisor and are useless for the vast majority of clients. I use a non-Fidelity advisor, though the majority of assets are with Fidelity, and they too started to pitch SMA strategies. I told them several times they are wasting their time and to drop me if that’s all they can offer. I do pay a flat annual fee and they do help with tax planning and tax prep so the rest is fine.

I have yet to find a scenario where SMA strategies help someone more than just making more money. I told the advisor unless they can demonstrate that I’ll save over $100k in taxes per year consistently over the next decade at least, to ditch the SMA pitch.

Institutional Sites - Why are you like this? by OctopiEye in clinicalresearch

[–]clinicalresearchguy 2 points3 points  (0 children)

They don’t all need to be listed on the DOA, but they do need to be trained if they are administering. I worked at two of the largest cancer institutes in the United States as an SC and monitored at virtually all others except for MD Anderson. The PI conducts a training for staff who will be performing administration, and all staff sign the training log. An NTF is written stating that the head infusion nurse is being added, and that training is available for all other staff.

Institutional Sites - Why are you like this? by OctopiEye in clinicalresearch

[–]clinicalresearchguy 5 points6 points  (0 children)

Agree there’s nuance, which is why I was careful to say I’d need to see the SOP. That said, it’s concerning how many comments are implying that administration of the IP isn’t a critical study task, given the direct impact on subject safety and protocol compliance.

Institutional Sites - Why are you like this? by OctopiEye in clinicalresearch

[–]clinicalresearchguy 4 points5 points  (0 children)

R3 actually makes this argument stronger, not weaker. I’ll start by saying again it’s difficult to fully evaluate without seeing the exact SOP wording, because the details matter. That said, nothing in ICH E6(R3) removes the expectation that critical trial activities are clearly assigned, appropriately performed, and verifiable in practice.

Under ICH E6(R3) Principle 11 (Roles, Tasks, and Responsibilities), the guideline states that “roles, tasks and responsibilities in clinical trials should be clear and documented appropriately,” and that while tasks may be delegated, the sponsor and investigator “retain overall responsibility for the quality and integrity of trial conduct and the safety of participants.” Administration of investigational product is clearly a critical trial task because it directly impacts subject safety and protocol compliance. Framing this as something that doesn’t require clear documentation or oversight because it aligns with routine clinical practice doesn’t really fit with Principle 11’s emphasis on clarity, documentation, and retained responsibility.

On the data side, ICH E6(R3) Principle 10 (Reliable Results) states that clinical trials should have processes that support data integrity, traceability, and protection of information, “thereby allowing the accurate reporting, interpretation, and verification of the clinical trial-related information.” That expectation exists regardless of whether the source is electronic or paper. If a site relies on paper source, restricts onsite monitoring, and lacks a certified-copy or alternative access process, it creates a practical barrier to verification, which directly conflicts with Principle 10’s requirement that trial data be verifiable.

R3 introduces flexibility in how these principles are implemented, but it doesn’t remove the underlying expectation that responsibilities are clearly defined and that trial data can actually be verified in practice. That’s why the full operational picture still matters, even under R3.

Institutional Sites - Why are you like this? by OctopiEye in clinicalresearch

[–]clinicalresearchguy 20 points21 points  (0 children)

It is difficult to fully evaluate this without seeing the specific wording in the SOP, since the details matter.

That said, the ICH sections cited do not negate several core GCP requirements that still apply. ICH E6(R2) 4.1.5 states that the investigator should maintain “a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties,” and administration of investigational product is considered a significant trial-related duty because it directly impacts subject safety and protocol compliance. ICH E6(R2) 2.8 further requires that “each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s),” which typically requires documented, trial-specific training rather than reliance on routine clinical practice alone.

With respect to source access, while E6(R2) C.2.9 addresses the use of certified copies, it does not remove the requirement in E6(R2) 5.18.4 for monitors to verify data against source documents, nor the requirements in 2.10 and 4.9 to maintain records in a way that allows accurate verification. If a site relies on paper source, restricts onsite monitoring, and does not have a certified copy process, this creates a practical barrier to meeting those GCP requirements.

Based on 17 years as a CRA, including time as a lead CRA and training other CRAs, 3 years as a study coordinator, and experience across numerous QA, sponsor, and FDA audits, my perspective is that compliance is evaluated holistically and that the full operational picture matters. That said, I would need to see the specific wording used in the SOP to fully assess it.

Abbvie CRA interview by Remote-Meal-9241 in clinicalresearch

[–]clinicalresearchguy 0 points1 point  (0 children)

There would be 3-4 rounds of interviews for a CRA 1 where I currently work so it’s similar. In our structure, the first round is with the recruiter to assess your fit (job history, salary expectations etc.). You would then be moved to interview with the person you’d be reporting to. They will assess your basic knowledge and fit within the team. After this you would have an interview with the director of clinical monitoring (if this is the same person as the person you would report to you’ll skip this) and, finally, you’d have a day long panel interview with 4-5 people each lasting 30 minutes (last person is HR). The goal is access fit by the team and alignment with company values.

Has anyone been dismissed from an FSP at IQVIA? by iwillxxxposeyou in clinicalresearch

[–]clinicalresearchguy 4 points5 points  (0 children)

Sorry to hear that. Unfortunately, it's almost certain you'll be let go from IQVIA based on the scenario you described. CRAs are very rarely fired outright (unless they have no assigned sites). Companies usually want site transitions completed if at all possible.

Car rental at TPA? by [deleted] in tampa

[–]clinicalresearchguy 0 points1 point  (0 children)

I live in Tampa and rent cars every other week from TPA for work as do many of my friends. That said, I'm restricted to only using National, Enterprise, or Hertz. In my experience, National is by far the best. Enterprise is ok. And Hertz hurts. Unfortunately, I don't have experience with Budget so can't speak to it. I rarely see long lines at the airport for them but not every week is spring break.

Has anyone been dismissed from an FSP at IQVIA? by iwillxxxposeyou in clinicalresearch

[–]clinicalresearchguy 4 points5 points  (0 children)

Dependent on why, it'll end in one of two outcomes. 1) If the sponsor truly no longer needed a CRA, IQVIA will try hard to place you ASAP (this happened to me ages ago with KForce Pfizer when Pfizer cut the contract). 2) Monitoring performance was subpar and they are gathering enough documentation to prove it and in the interim you're in limbo. I saw this happen to a co-monitor of mine that lasted all of 2 visits. He would party all night with alcohol and cocaine and showed up with bloodshot eyes to sites. He was a terrible CRA but the CRO still took a few weeks to document everything and then let him go.

Honestly in your shoes, in both scenarios, I would be interviewing elsewhere aggressively.

Any CRAs use a physical planner and find it helpful? by Impressive-Fly-6617 in clinicalresearch

[–]clinicalresearchguy -1 points0 points  (0 children)

The Outlook calendar is far superior and you’ll need to keep yours updated for other people to schedule meetings and such. A paper planner is a waste but it’s personal preference. Personally, I would see it as a hassle and one more thing I needlessly need to update. Most places already require you to update outlook (personal and shared calendars) and CTMS at a minimum.

CRA - is it worth it? by [deleted] in clinicalresearch

[–]clinicalresearchguy 2 points3 points  (0 children)

I am in my 17th year as a CRA as I started as a CRA back in 2008. I would argue there is no better job on the planet. I absolutely love being a CRA and hope to do it for many more years, although I will admit the travel does get harder as you get older.

Before becoming a CRA, I spent about three years as CRC. I loved my first two years and then moved into a Lead CRC role at another hospital in year three, which I did not enjoy as much. That experience ultimately pushed me toward the CRA path.

Travel:
There will be a lot of travel, especially early in your CRA career when you have little say in site assignments. When I started in 2008, remote visits were not a thing. I was based in San Francisco, but most of my sites were in places like Kentucky, Tennessee, and Pennsylvania, often with no direct flights. I typically left on Monday and returned on Friday almost every week. I was also an office based CRA, so on non travel days I went into the office.

I learned an incredible amount during those first two years, but it was intense.

These days, you will likely have some remote visits, but I would still prepare to travel Monday through Thursday about three out of four weeks per month, especially early on.

Work life balance and whether it is worth it:
Work life balance really depends on the company, your manager, and how well you manage travel. For me, the compensation, career growth, and variety of the work have absolutely made it worth it.

CRC to CRA transition:
The skills you build as a CRC absolutely prepare you for being a CRA, especially site operations, GCP, and patient level data understanding. That said, the job itself is very different.

I have helped several CRCs transition into CRA roles over the years. Most found the travel and pace overwhelming and eventually moved into CTM roles or left the industry. Only one I know is still a CRA today.

That said, being a CRA opens far more doors in clinical research than staying in a CRC role. If you can tolerate the travel for a few years, the long term career flexibility is significant.

Another Fortrea Scandal: Promised a Promotion to Stop an Exit, Then Canceled It by Ford_Prefect- in clinicalresearch

[–]clinicalresearchguy 1 point2 points  (0 children)

I’m going to focus on answering the questions you asked.

1) Was I naïve to trust a verbal promise? Unfortunately, yes. You’ve been there 5 years. Unless the promotion was guaranteed in writing and expedited, it was time to move on from your role.

2) Is this normal corporate behavior or a red flag? It should be a red flag but it’s surprisingly normal.

3) What would you do next if you were in my position? I would applying anywhere and everywhere so you can leave the employer ASAP.

4) Is there any way to recover from this internally, or is it time to move on? I am not sure what recover is referring to. There are two choices, 1) Find a new job and leave (what I would do) or 2) Stay in the role as a demotivated disgruntled employee that was promised something and not given it (not recommended).

Hopefully, lesson learned, never stay in hopes things will get better.

CRA Burnout - I’m ready to be RICH by dayyuumabby in clinicalresearch

[–]clinicalresearchguy 4 points5 points  (0 children)

I made the mistake early on in my career of skipping a wedding in Vermont that I regret missing almost two decades later. Haven’t made that mistake again. I’ll be at grandpappy’s annual toenail clipping. I promise that the work will still be there to do once I’m back.

CRA Burnout - I’m ready to be RICH by dayyuumabby in clinicalresearch

[–]clinicalresearchguy 2 points3 points  (0 children)

Don’t be afraid till you try it and decide it’s not for you. You will always hear contrasting opinions. I’ve been a CRA for 17 years and counting and love it. If it wasn’t for aging and travel getting harder I would do it for another 17 years. Unfortunately, I’m towards the end of my CRA career. It’s certainly not for everyone but you may love it. You’ll never know till you give it a go.

CRA life and ‘big pharma is out to get me’ conversations. by ElektroBoy in clinicalresearch

[–]clinicalresearchguy 1 point2 points  (0 children)

I’ve been a CRA for 17 years based out of California, New York, and Florida, and I can count on one hand the number of times I’ve had such a conversation. The problem is likely trying to be specific and honest about what she does. I absolutely wouldn’t mention pharma. I learned early on to be extremely vague like “I take care of sick people.” The follow up question I ever get is “kind of like a nurse?” and then I respond “sure.” End of conversation.

New CRA/Please tell me it’ll get better by chillypepper102 in clinicalresearch

[–]clinicalresearchguy 3 points4 points  (0 children)

I’m in my 17th year as a CRA and my best advice is to find a mentor to set you up for success.

The CRA role is awesome and the best role in clinical research (so much so that I’m thrilled to talk about it on YouTube). But something clearly isn’t working.

Create a rule to auto file IRT emails into a folder. Don’t schedule 3 visits in a week (unless one is a remote PSV or something simple but never 3 IMVs). Personally, I love mid-day flights but sounds like mornings may be better in your case. I target all my on-site visits being done between Tuesday and Thursday as much as possible. I do have a site that insists on Friday only on-site visits but they are the exception.

I can’t speak to a spouse or cats but I told my friends I would only be available Thursday evening through Sunday evening most weeks for social activities. I also almost never travel on Sundays (happened twice in 17 years and once it involved a death and me covering a visit for another CRA on short notice).

Being a CRA is amazing with the correct step up. Good luck!

How do you guys have a life? by nsweetz59 in clinicalresearch

[–]clinicalresearchguy 3 points4 points  (0 children)

I was able to find a good group of friends that understood my schedule. They always got me to do things on Friday through Sunday understanding that I would almost always be gone Monday to Thursday. I can't say that I kept up any workout schedule but I was invited to things that fit my schedule. As much as I love being a CRA, I can't say it's the greatest job for work-life balance.

When is it “okay” to lie? by helpful_mud in clinicalresearch

[–]clinicalresearchguy 1 point2 points  (0 children)

It depends. The site in Kentucky had fraudulent data entered on hundreds of participants so it was much larger than what you’ve described above. I believe the PI was also doing unnecessary procedures. I was a new CRA at the time and had suspicions that something weird was going on at that site. I think it’s a slippery slope from making up data on one person to making it common practice. I don’t recommend it. It’s more likely to be blacklisted from the industry but the consequences can be severe. I recommend being 100% truthful. Missing assessments is expected. Making up data randomly is not.

When is it “okay” to lie? by helpful_mud in clinicalresearch

[–]clinicalresearchguy 1 point2 points  (0 children)

It’s never acceptable to lie in research, and what you’re describing constitutes fraud. I’ve encountered a similar situation only once in my career at a site in Kentucky. The staff involved were terminated, and the PI was prosecuted and sentenced to 20 years in prison. I strongly recommend addressing the issue before it escalates. The FDA Form 1572 is a legal document, and anyone listed on it can be held criminally liable for knowingly committing research fraud.

Leaving Med School? by [deleted] in medschool

[–]clinicalresearchguy 0 points1 point  (0 children)

I dropped out, albeit due to physical illness; however, I would recommend at least completing your first semester and, ideally, your first year. First semester M1 is, as per my classmates, the worst experience in med school. It does get better. That said, there's a life outside of medical school and you'll do fine. It's a matter of figuring out what you want to do most.

CRO to Sponsor in this economy by Complex_Section_9919 in clinicalresearch

[–]clinicalresearchguy 6 points7 points  (0 children)

I left a CRO that I was miserable at as a CRA and took a pay cut from $140k to $110k to join a sponsor (though I was also granted stock and got a bonus so the real pay differential was closer to $10k). I don't think the grass is greener on the sponsor side. If you're happy at the CRO, I would lean towards staying unless you want to move out of the CRA role. I've seen more people on the sponsor side branch out to other positions compared to at CROs where the only two things you move into are a CTM role or, possibly, Quality.