Clinical Operations work is inherently rewarding. After all, your effort directly affects scientific knowledge and the chances of a great drug helping patients.
It’s also exciting. You get to participate in the very last stage of the (years long) drug discovery process.
However, Clin Ops is also complex and highly collaborative, with many moving pieces. In other words, it’s a perfect environment for chaos! See if you relate to any of these pet peeves (in no specific order).
#1 – The Key Decision Maker never shows to the meeting.
You’re feeling good. You sent the meeting invite months ago, after painstakingly coordinating attendee schedules. Everyone accepted the invite. You’re looking forward to the resolution of a decision that has been gating a huge study milestone. The meeting starts. 10 minutes pass. Frantic emails and instant messages are sent. 15 more minutes pass. The meeting is adjourned to be rescheduled.
#2 – Venting about your CRO has become a team sport.
Your CRO weekly meeting just ended. But the 15 minute post-meeting vent session has just started.
#3 – Your master plan to review 3 monitoring reports and file 10 TMF documents each week falls through.
You end up telling yourself you’ll get to them when you “have time”.
#4 – Congrats. You’re now the CTA, CRA, and CTM of a huge Phase 3 trial.
#5 – You have a pre-meeting to prepare for your Big Meeting. And then a post-meeting to discuss the outcome of your Big Meeting.
#6 – You see the email you were expecting. The one with critical info gating a subject’s enrollment before the screening deadline.
Never mind – it’s from a recruiter. Or a vendor detailing a new clinical operations solution ;).
#7 – The Key Opinion Leader’s site has agreed to participate in your trial.
However, they will take 1 year to activate. They also refuse to use your EDC or IXRS systems and will only allow your monitor onsite every 4 months.
#8 – It’s Inspection Readiness Time already?
#9 – You have one study in start-up, one in close-out, and two in maintenance.
You’ve also just been assigned an “easy” Expanded Access Trial. On the bright side, you have a new CRA who is allocated 7.3% across all your studies.
