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Sunday, November 2, 2008

I'm alive

I've been getting a lot of emails and comments asking where I have been since August. I apologize for not posting (I have almost 40 topics begun/drafted but just haven't had time to pull the trigger on posting any of them!). For those of you that check back here often, I appreciate your interest and support and I promise to get back to posting soon. Several of you have posted and emailed me specific questions and I will address all of those as soon as possible. For today, however, just a quick explanation as to what I've been up to...

So here is my excuse, I have been assigned to a nightmare Phase II surgery study that was fully enrolled but looked like it might never lock so they ramped up on staff. At first I was just co-monitoring and helping others clean up their sites but (the reward for a job well down is always more work) I was eventually given two of the four worst sites to manage. I've been told this is a compliment and that management knew I could get the work done and salvage the data...but really though, I'm feeling like a sucker for accepting the assignment! In all seriousness, this study has been a great learning opportunity and I have grown a lot in just a few short months.

The good news is that my two sites are only about 1000 miles away and I have had no trouble getting direct and inexpensive flights. Of course they are in a different time zone, and I have basically been living at these sites (flying in on Sundays and coming home late Thursdays or Friday) and can barely remember what my own home looks like! One site lets me arrive around 7 in the morning and the other one locks me in at night and lets me stay as long as I want so that has made for some extremely long days. The bad news is that the protocol is complicated, there have been significant changes in staff and limited resourcing at both sites, PI oversight was generally lacking, subject charts are very very thick (they are hospitalized for about a week and then many subjects go to rehab), both of my sites enrolled subjects that were not eligible, neglected to report SAEs and AEs that are of special interest to the sponsor, performed major dosing errors, failed to adhere to the protocol (often times just neglecting to do entire procedures or study visits), and reported their errors inconsistently (or not at all) to both the sponsor and the IRB. I feel like I am missing something...ah yes, one of the sites was audited by the sponsor and shut down (too late in my opinion and of course now I have to prepare audit responses) but you get the idea - it is a total mess.

On a positive note, this study has excellent leadership and I have been learning a lot and becoming much more confident. I've even been getting lots of extra resources to help me get the job done. On any given week, I have up to 7 CRAs (many much more experienced and Senior than me) helping pour through the charts and finish the pending SDV. It has been fun to be in charge and even more fun to go to dinner and debrief with my fabulous colleagues. I'm so grateful for all the terrific help I have been sent but it has been an exhausting few months. Supposedly we will lock at the end of November...just in time for a PI sign-off at the holidays and that always goes so well (*wink wink*).

I still get contacted by recruiters at least 3 times a week (how do they even get your info?) but I'm really in a holding pattern right now and not looking to make a change. I've been with my CRO for a year and anytime I have gotten frustrated, overwhelmed, or cornered, my boss and Project Managers have always had my back and given me great support. I've built a pretty good reputation for myself as a top producer, eagerly accepting all assignments, highly organized, and extremely flexible in a dynamic environment. I've been chatting with my boss recently about my career development and possibly stepping into a Lead CRA role so I will keep everyone posted as things progress. Ah yes, and I will post more to my blog. Soon, I promise. ;)

1 comment:

N@viN ReDDY said...

Thats great news. Talent is always promoted. We look forward for the news of your transition to lead cra.

Regards,
Naveen
www.clinicalresearchzone.blogspot.com

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