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
· Dec 8
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)
If a monitor asked "show me your diversity efforts" tomorrow, could you pull the receipts?
Start simple: screening demographics by zip code, your community partnership list, accommodations you've actually made.
You don't need perfect. You need documented.
#ClinicalResearch #ScienceFeed
Start simple: screening demographics by zip code, your community partnership list, accommodations you've actually made.
You don't need perfect. You need documented.
#ClinicalResearch #ScienceFeed
January 15, 2026 at 11:14 PM
If a monitor asked "show me your diversity efforts" tomorrow, could you pull the receipts?
Start simple: screening demographics by zip code, your community partnership list, accommodations you've actually made.
You don't need perfect. You need documented.
#ClinicalResearch #ScienceFeed
Start simple: screening demographics by zip code, your community partnership list, accommodations you've actually made.
You don't need perfect. You need documented.
#ClinicalResearch #ScienceFeed
One site doubled Hispanic enrollment by adding evening appointment slots.
Not a program. Not a budget. Just removed a barrier.
The best diversity strategies aren't expensive. They're intentional.
#ClinicalResearch
Not a program. Not a budget. Just removed a barrier.
The best diversity strategies aren't expensive. They're intentional.
#ClinicalResearch
January 15, 2026 at 1:08 AM
One site doubled Hispanic enrollment by adding evening appointment slots.
Not a program. Not a budget. Just removed a barrier.
The best diversity strategies aren't expensive. They're intentional.
#ClinicalResearch
Not a program. Not a budget. Just removed a barrier.
The best diversity strategies aren't expensive. They're intentional.
#ClinicalResearch
Sites don't submit DAPs (sponsors do). What actually matters for enrollment? Documentation quality and community trust.
Sites don't submit DAPs (sponsors do). What actual
Check out the latest newsletter
open.substack.com
January 14, 2026 at 1:12 AM
Sites don't submit DAPs (sponsors do). What actually matters for enrollment? Documentation quality and community trust.
Monday morning in clinical research: You're doing work that matters. Even when the systems fight you, even when recruitment stalls, you're moving medicine forward.
Let's make this week count.
#ClinicalResearch #ScienceFeed
Let's make this week count.
#ClinicalResearch #ScienceFeed
January 12, 2026 at 11:12 PM
Monday morning in clinical research: You're doing work that matters. Even when the systems fight you, even when recruitment stalls, you're moving medicine forward.
Let's make this week count.
#ClinicalResearch #ScienceFeed
Let's make this week count.
#ClinicalResearch #ScienceFeed
Quick question for my clinical research folks:
What's your #1 operational priority heading into 2026? Patient recruitment? Regulatory burden? System overload?
I'm curious what's keeping you up at night. No wrong answers.
#ClinicalResearch #ClinicalTrials
What's your #1 operational priority heading into 2026? Patient recruitment? Regulatory burden? System overload?
I'm curious what's keeping you up at night. No wrong answers.
#ClinicalResearch #ClinicalTrials
January 11, 2026 at 11:14 PM
Quick question for my clinical research folks:
What's your #1 operational priority heading into 2026? Patient recruitment? Regulatory burden? System overload?
I'm curious what's keeping you up at night. No wrong answers.
#ClinicalResearch #ClinicalTrials
What's your #1 operational priority heading into 2026? Patient recruitment? Regulatory burden? System overload?
I'm curious what's keeping you up at night. No wrong answers.
#ClinicalResearch #ClinicalTrials
Spending my Saturday untangling a tricky workflow automation. Same feeling as when I'd finally crack a recruitment bottleneck at 4pm on a Friday.
Some things don't change. Just the tools we use to solve them.
#ClinicalResearch #MSky
Some things don't change. Just the tools we use to solve them.
#ClinicalResearch #MSky
January 10, 2026 at 11:13 PM
Spending my Saturday untangling a tricky workflow automation. Same feeling as when I'd finally crack a recruitment bottleneck at 4pm on a Friday.
Some things don't change. Just the tools we use to solve them.
#ClinicalResearch #MSky
Some things don't change. Just the tools we use to solve them.
#ClinicalResearch #MSky
Who called it 'consent form update' and not 'surprise, re-consent everyone'
#ClinicalResearch #MSky
#ClinicalResearch #MSky
January 9, 2026 at 11:14 PM
Who called it 'consent form update' and not 'surprise, re-consent everyone'
#ClinicalResearch #MSky
#ClinicalResearch #MSky
If you're coordinating trials: start auditing your source doc workflows now. 2026 regs will tighten traceability requirements.
The sites that'll adapt fastest? The ones who already know where their process gaps are.
Future you will thank present you.
#ClinicalResearch #CRC
The sites that'll adapt fastest? The ones who already know where their process gaps are.
Future you will thank present you.
#ClinicalResearch #CRC
January 8, 2026 at 11:13 PM
If you're coordinating trials: start auditing your source doc workflows now. 2026 regs will tighten traceability requirements.
The sites that'll adapt fastest? The ones who already know where their process gaps are.
Future you will thank present you.
#ClinicalResearch #CRC
The sites that'll adapt fastest? The ones who already know where their process gaps are.
Future you will thank present you.
#ClinicalResearch #CRC
The new GCP update (ICH E6 R3) sounds scary, but here's what actually matters for coordinators: more flexibility on monitoring, clearer rules on digital tools, stronger patient focus.
Translation: less micromanagement, more trust in what you already do well.
#ClinicalResearch #CRC
Translation: less micromanagement, more trust in what you already do well.
#ClinicalResearch #CRC
The new GCP update (ICH E6 R3) sounds scary, but h
Check out the latest newsletter
open.substack.com
January 8, 2026 at 1:09 AM
The new GCP update (ICH E6 R3) sounds scary, but here's what actually matters for coordinators: more flexibility on monitoring, clearer rules on digital tools, stronger patient focus.
Translation: less micromanagement, more trust in what you already do well.
#ClinicalResearch #CRC
Translation: less micromanagement, more trust in what you already do well.
#ClinicalResearch #CRC
2026 is bringing a lot to clinical research sites. New GCP guidelines, more FDA inspections, and the workforce crisis isn't slowing down.
2026 is bringing a lot to clinical research sites.
Check out the latest newsletter
open.substack.com
January 6, 2026 at 11:14 PM
2026 is bringing a lot to clinical research sites. New GCP guidelines, more FDA inspections, and the workforce crisis isn't slowing down.
To all the research coordinators starting Q1 with new protocols and the same impossible juggle: I see you.
You're the backbone of clinical trials. The work is hard, the systems are clunky, but your resilience makes breakthroughs possible.
Here's to you. 💙
#ClinicalResearch #CRC
You're the backbone of clinical trials. The work is hard, the systems are clunky, but your resilience makes breakthroughs possible.
Here's to you. 💙
#ClinicalResearch #CRC
January 5, 2026 at 11:14 PM
To all the research coordinators starting Q1 with new protocols and the same impossible juggle: I see you.
You're the backbone of clinical trials. The work is hard, the systems are clunky, but your resilience makes breakthroughs possible.
Here's to you. 💙
#ClinicalResearch #CRC
You're the backbone of clinical trials. The work is hard, the systems are clunky, but your resilience makes breakthroughs possible.
Here's to you. 💙
#ClinicalResearch #CRC
Sunday prep mode: time to make your site list, review enrollment pipelines, and mentally rehearsing Monday's chaos.
Hope this week treats you well.
#ClinicalResearch #CRC
Hope this week treats you well.
#ClinicalResearch #CRC
January 4, 2026 at 11:14 PM
Sunday prep mode: time to make your site list, review enrollment pipelines, and mentally rehearsing Monday's chaos.
Hope this week treats you well.
#ClinicalResearch #CRC
Hope this week treats you well.
#ClinicalResearch #CRC
Question for my fellow CRCs: if you could fix ONE thing in your workflow this year, what would it be?
For me it was always the patient recruitment follow-up. Curious what's top of mind for you all.
#ClinicalResearch #CRC
For me it was always the patient recruitment follow-up. Curious what's top of mind for you all.
#ClinicalResearch #CRC
January 3, 2026 at 11:13 PM
Question for my fellow CRCs: if you could fix ONE thing in your workflow this year, what would it be?
For me it was always the patient recruitment follow-up. Curious what's top of mind for you all.
#ClinicalResearch #CRC
For me it was always the patient recruitment follow-up. Curious what's top of mind for you all.
#ClinicalResearch #CRC
Coming back after the holidays? Block your first hour for admin catch-up only. No patient calls, no new emails. Just triage what broke while you were gone.
Your afternoon self will thank you.
#ClinicalResearch #CRC
Your afternoon self will thank you.
#ClinicalResearch #CRC
January 2, 2026 at 12:28 PM
Coming back after the holidays? Block your first hour for admin catch-up only. No patient calls, no new emails. Just triage what broke while you were gone.
Your afternoon self will thank you.
#ClinicalResearch #CRC
Your afternoon self will thank you.
#ClinicalResearch #CRC
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