Sarah Lee
@sarah.maxoutput.ai
Former Research Coordinator, now building automation for clinical research sites. President & Co-founder @MaxOutput.
Less time on admin, more time advancing research and patient care.
Less time on admin, more time advancing research and patient care.
Pinned
Sarah Lee
@sarah.maxoutput.ai
· 24d
I left clinical research in October after nearly 4 years in the clinical trial space. I loved the work - the patients, my colleagues, and progressing research. I didn't love the operational chaos. (1/4)
2026 is your year.
To every coordinator juggling impossible workloads: you're not behind. You're keeping trials moving despite broken systems.
This year, let's fix what we can control. Starting with the bottlenecks stealing your time.
You've got this. #ClinicalResearch
To every coordinator juggling impossible workloads: you're not behind. You're keeping trials moving despite broken systems.
This year, let's fix what we can control. Starting with the bottlenecks stealing your time.
You've got this. #ClinicalResearch
January 1, 2026 at 11:14 PM
2026 is your year.
To every coordinator juggling impossible workloads: you're not behind. You're keeping trials moving despite broken systems.
This year, let's fix what we can control. Starting with the bottlenecks stealing your time.
You've got this. #ClinicalResearch
To every coordinator juggling impossible workloads: you're not behind. You're keeping trials moving despite broken systems.
This year, let's fix what we can control. Starting with the bottlenecks stealing your time.
You've got this. #ClinicalResearch
To everyone in clinical research wrapping up 2025: you've earned this break. Close out your studies, log off, and actually rest. The patients you serve need you recharged.
Happy New Year. 🎊
#ClinicalResearch #MedSky
Happy New Year. 🎊
#ClinicalResearch #MedSky
December 31, 2025 at 11:14 PM
To everyone in clinical research wrapping up 2025: you've earned this break. Close out your studies, log off, and actually rest. The patients you serve need you recharged.
Happy New Year. 🎊
#ClinicalResearch #MedSky
Happy New Year. 🎊
#ClinicalResearch #MedSky
Just sent this week's newsletter. No "new year new you" nonsense. Honest look at what 2025 taught us about site operations. 76% of trials amended, 35%+ turnover, same portal chaos. (thread) 👇
maxoutput.substack.com/p/the-good-t...
maxoutput.substack.com/p/the-good-t...
The Good, the Brutal, and What's Coming: 2025 in Review
2025 broke clinical research; 2026 is about surviving the new normal.
maxoutput.substack.com
December 31, 2025 at 4:58 AM
Just sent this week's newsletter. No "new year new you" nonsense. Honest look at what 2025 taught us about site operations. 76% of trials amended, 35%+ turnover, same portal chaos. (thread) 👇
maxoutput.substack.com/p/the-good-t...
maxoutput.substack.com/p/the-good-t...
2026 is bringing changes to clinical research that I hadn't seen in my 4 years in ops.
Some will help sites. Some will make coordinators' lives harder.
Starting in January, I'll break down what's actually coming - and what it means for enrollment.
#ClinicalResearch #ScienceFeed
Some will help sites. Some will make coordinators' lives harder.
Starting in January, I'll break down what's actually coming - and what it means for enrollment.
#ClinicalResearch #ScienceFeed
December 30, 2025 at 1:08 AM
2026 is bringing changes to clinical research that I hadn't seen in my 4 years in ops.
Some will help sites. Some will make coordinators' lives harder.
Starting in January, I'll break down what's actually coming - and what it means for enrollment.
#ClinicalResearch #ScienceFeed
Some will help sites. Some will make coordinators' lives harder.
Starting in January, I'll break down what's actually coming - and what it means for enrollment.
#ClinicalResearch #ScienceFeed
#ClinicalResearch #ClinicalTrials
December 29, 2025 at 1:13 AM
#ClinicalResearch #ClinicalTrials
Spending the holiday break thinking about how to give coordinators their time back in 2026.
The work matters too much to lose hours to broken systems.
Hope you're getting some actual rest this week. #ClinicalResearch
The work matters too much to lose hours to broken systems.
Hope you're getting some actual rest this week. #ClinicalResearch
December 27, 2025 at 4:27 AM
Spending the holiday break thinking about how to give coordinators their time back in 2026.
The work matters too much to lose hours to broken systems.
Hope you're getting some actual rest this week. #ClinicalResearch
The work matters too much to lose hours to broken systems.
Hope you're getting some actual rest this week. #ClinicalResearch
Merry Christmas! Especially to everyone in the clinical research community. You rock!
#ClinicalResearch
#ClinicalResearch
December 26, 2025 at 1:07 AM
Merry Christmas! Especially to everyone in the clinical research community. You rock!
#ClinicalResearch
#ClinicalResearch
Merry Christmas to all the research coordinators out there. I see you. The work you do matters more than you know.
#ClinicalResearch #CRC
#ClinicalResearch #CRC
December 26, 2025 at 1:07 AM
Merry Christmas to all the research coordinators out there. I see you. The work you do matters more than you know.
#ClinicalResearch #CRC
#ClinicalResearch #CRC
Wishing everyone a happy and healthy holiday season!
#ClinicalResearch
#ClinicalResearch
December 26, 2025 at 1:07 AM
Wishing everyone a happy and healthy holiday season!
#ClinicalResearch
#ClinicalResearch
To everyone in clinical research working today: thank you. Your work matters more than you know.
Wishing you all a peaceful holiday. See you soon.
#ClinicalResearch #MSky
Wishing you all a peaceful holiday. See you soon.
#ClinicalResearch #MSky
December 25, 2025 at 1:07 AM
To everyone in clinical research working today: thank you. Your work matters more than you know.
Wishing you all a peaceful holiday. See you soon.
#ClinicalResearch #MSky
Wishing you all a peaceful holiday. See you soon.
#ClinicalResearch #MSky
Our holiday Site Sanity issue dropped. I'm sharing what I'm watching in 2026 for clinical research ops (and one thing I hope we finally leave behind).
If you're not subscribed yet: maxoutput.substack.com
#ClinicalResearch #MSky
If you're not subscribed yet: maxoutput.substack.com
#ClinicalResearch #MSky
Site Sanity | Substack
Site Sanity is a weekly newsletter with practical operations insights for CRCs and site managers. Click to read Site Sanity, a Substack publication.
maxoutput.substack.com
December 24, 2025 at 1:01 AM
Our holiday Site Sanity issue dropped. I'm sharing what I'm watching in 2026 for clinical research ops (and one thing I hope we finally leave behind).
If you're not subscribed yet: maxoutput.substack.com
#ClinicalResearch #MSky
If you're not subscribed yet: maxoutput.substack.com
#ClinicalResearch #MSky
The most underrated superpower in clinical research? Setting realistic timelines during the SIV.
The ones who over-promise? They're the ones drowning in unrealistic expectations three months later.
Your site's capacity is what it is. Naming it upfront isn't difficult, it's professional.
The ones who over-promise? They're the ones drowning in unrealistic expectations three months later.
Your site's capacity is what it is. Naming it upfront isn't difficult, it's professional.
December 22, 2025 at 7:22 PM
The most underrated superpower in clinical research? Setting realistic timelines during the SIV.
The ones who over-promise? They're the ones drowning in unrealistic expectations three months later.
Your site's capacity is what it is. Naming it upfront isn't difficult, it's professional.
The ones who over-promise? They're the ones drowning in unrealistic expectations three months later.
Your site's capacity is what it is. Naming it upfront isn't difficult, it's professional.
Some days: phlebotomist delays, changing I/E criteria, screening calls that end in rejection. I used to blame myself. The truth? The system prioritizes compliance over efficiency, leaving manual work that delays patients.
December 21, 2025 at 3:30 PM
Some days: phlebotomist delays, changing I/E criteria, screening calls that end in rejection. I used to blame myself. The truth? The system prioritizes compliance over efficiency, leaving manual work that delays patients.
I still think about the woman who almost cried during screening. An hour long call and a medical records check revealed that her labs were slightly outside range. An hour of her hope - gone. Should have been caught during prescreening.
December 20, 2025 at 8:29 PM
I still think about the woman who almost cried during screening. An hour long call and a medical records check revealed that her labs were slightly outside range. An hour of her hope - gone. Should have been caught during prescreening.
When I was a coordinator, I noticed that my teammates kept asking me questions about the study they could've looked up.
Then I realized - it was genuinely faster to walk over and ask me than to dig through 4 different systems and a 200-page protocol.
Then I realized - it was genuinely faster to walk over and ask me than to dig through 4 different systems and a 200-page protocol.
December 19, 2025 at 7:01 PM
When I was a coordinator, I noticed that my teammates kept asking me questions about the study they could've looked up.
Then I realized - it was genuinely faster to walk over and ask me than to dig through 4 different systems and a 200-page protocol.
Then I realized - it was genuinely faster to walk over and ask me than to dig through 4 different systems and a 200-page protocol.
I used to think I failed at study startup. Then I realized: this isn't personal failure. It's just startup in clinical research.
You're not drowning because you're not good enough. You're drowning because the process IS overwhelming.
If you're in startup chaos right now - you're doing great.
You're not drowning because you're not good enough. You're drowning because the process IS overwhelming.
If you're in startup chaos right now - you're doing great.
December 18, 2025 at 8:02 PM
I used to think I failed at study startup. Then I realized: this isn't personal failure. It's just startup in clinical research.
You're not drowning because you're not good enough. You're drowning because the process IS overwhelming.
If you're in startup chaos right now - you're doing great.
You're not drowning because you're not good enough. You're drowning because the process IS overwhelming.
If you're in startup chaos right now - you're doing great.
The thing about monitor visits nobody tells you: block 30-60 min AFTER they leave.
That's when the actual work happens - updating tracking logs, filing new source docs, addressing action items while they're fresh.
What's your post-visit routine look like?
That's when the actual work happens - updating tracking logs, filing new source docs, addressing action items while they're fresh.
What's your post-visit routine look like?
December 17, 2025 at 7:43 PM
The thing about monitor visits nobody tells you: block 30-60 min AFTER they leave.
That's when the actual work happens - updating tracking logs, filing new source docs, addressing action items while they're fresh.
What's your post-visit routine look like?
That's when the actual work happens - updating tracking logs, filing new source docs, addressing action items while they're fresh.
What's your post-visit routine look like?
I spent 8 months as a coordinator drowning in "urgent" tasks that didn't move patients closer to enrollment.
What I needed was a system.
We just dropped our Triage Framework - the decision tree I wish I had back then.
What I needed was a system.
We just dropped our Triage Framework - the decision tree I wish I had back then.
I spent 8 months as a coordinator drowning in "urg
Check out the latest newsletter
open.substack.com
December 16, 2025 at 1:51 PM
I spent 8 months as a coordinator drowning in "urgent" tasks that didn't move patients closer to enrollment.
What I needed was a system.
We just dropped our Triage Framework - the decision tree I wish I had back then.
What I needed was a system.
We just dropped our Triage Framework - the decision tree I wish I had back then.
Honest question for CRCs: how many systems do you log into before your first patient?
When I was coordinating, some mornings it was 10+. Just to START the day.
That's not inefficiency. That's the job now.
#ClinicalResearch #CRC
When I was coordinating, some mornings it was 10+. Just to START the day.
That's not inefficiency. That's the job now.
#ClinicalResearch #CRC
December 15, 2025 at 2:57 PM
Honest question for CRCs: how many systems do you log into before your first patient?
When I was coordinating, some mornings it was 10+. Just to START the day.
That's not inefficiency. That's the job now.
#ClinicalResearch #CRC
When I was coordinating, some mornings it was 10+. Just to START the day.
That's not inefficiency. That's the job now.
#ClinicalResearch #CRC
Saturday question for CRCs: What's the FIRST thing you check Monday morning? Email? CTMS? Patient schedule?
I've heard some people check queries first. Curious what everyone's routine looks like!
#ClinicalResearch #CRC
I've heard some people check queries first. Curious what everyone's routine looks like!
#ClinicalResearch #CRC
December 13, 2025 at 1:34 PM
Saturday question for CRCs: What's the FIRST thing you check Monday morning? Email? CTMS? Patient schedule?
I've heard some people check queries first. Curious what everyone's routine looks like!
#ClinicalResearch #CRC
I've heard some people check queries first. Curious what everyone's routine looks like!
#ClinicalResearch #CRC
I spent years as a RC drowning in screening logs and reminder emails while patients waited.
Automation should feel like a really good assistant - it handles the busywork so you're free for what matters.
What's the ONE admin task you wish would just handle itself?
Automation should feel like a really good assistant - it handles the busywork so you're free for what matters.
What's the ONE admin task you wish would just handle itself?
December 12, 2025 at 2:38 PM
I spent years as a RC drowning in screening logs and reminder emails while patients waited.
Automation should feel like a really good assistant - it handles the busywork so you're free for what matters.
What's the ONE admin task you wish would just handle itself?
Automation should feel like a really good assistant - it handles the busywork so you're free for what matters.
What's the ONE admin task you wish would just handle itself?
Question for CRCs: What's your most memorable screen failure story? Not the data - the person. The one that made you wish you had caught the eligibility issue earlier.
#ClinicalResearch #CRC
#ClinicalResearch #CRC
December 11, 2025 at 6:24 PM
Question for CRCs: What's your most memorable screen failure story? Not the data - the person. The one that made you wish you had caught the eligibility issue earlier.
#ClinicalResearch #CRC
#ClinicalResearch #CRC
Reposted by Sarah Lee
I've heard that 10-12 systems per study is the norm as a coordinator. It gets hard to remember which portal had what data.
If you're asking this question, you're not doing it wrong - the infrastructure is. You're just adapting to broken systems.
What's your count? #ClinicalResearch
If you're asking this question, you're not doing it wrong - the infrastructure is. You're just adapting to broken systems.
What's your count? #ClinicalResearch
December 10, 2025 at 8:58 PM
I've heard that 10-12 systems per study is the norm as a coordinator. It gets hard to remember which portal had what data.
If you're asking this question, you're not doing it wrong - the infrastructure is. You're just adapting to broken systems.
What's your count? #ClinicalResearch
If you're asking this question, you're not doing it wrong - the infrastructure is. You're just adapting to broken systems.
What's your count? #ClinicalResearch
44% of Clinical Research Coordinators score high on emotional exhaustion scales.
This isn't just an HR statistic. It's a retention crisis hiding in plain sight.
Here's what's changing in how we think about burnout: open.substack.com/pub/maxoutpu...
This isn't just an HR statistic. It's a retention crisis hiding in plain sight.
Here's what's changing in how we think about burnout: open.substack.com/pub/maxoutpu...
December 9, 2025 at 6:54 PM
44% of Clinical Research Coordinators score high on emotional exhaustion scales.
This isn't just an HR statistic. It's a retention crisis hiding in plain sight.
Here's what's changing in how we think about burnout: open.substack.com/pub/maxoutpu...
This isn't just an HR statistic. It's a retention crisis hiding in plain sight.
Here's what's changing in how we think about burnout: open.substack.com/pub/maxoutpu...