How I got here

Today I am reflecting on how I came to be a CRA and thought I would share the specifics of how I ended up where I am today.

I did an internship for the marketing department at a large pharmaceutical company all through college and then went to England my final semester to finish school and earn my degree in Business Management (coursework in Marketing and Computer Science). When I returned to the states I worked full time as a Clinical Project Assistant contractor at a large CRO for a few months doing patient recruitment, supporting the PIs when they had protocol or IVRS questions, managing study materials (CRFs, mailings, etc.), and performing Quality of Life (QOL) assessments to enrolled patients via the telephone. I wanted a permanent position so I joined a large specialty biotech working in commercial field sales support. After a few years, I was up for a promotion and relocation to another state, however, my boyfriend had an offer to move to San Francisco with his employer so I left on good terms and relocated with him.

I had been taking pre-requisites for nursing school before we relocated but eventually decided that stepping out of the workforce for up to 2 years would cost me more than the gains in salary than the RN credentials would give me so I abondoned my plans to get the RN BSN. In the Bay Area, I worked at a small data management firm and then a company that created EDC software. In these position I built databases, developed/programmed edit checks, and validated databases for various studies in multiple therapeutic areas such as oncology, device, cardiac, etc. From there I moved on to an in-house Data Management position and provided support for biostats and managed external vendors. I made connections with the clinical group and networked my way into an open in-house CRA position.

In order to prove my commitment to the CRA career trek, I took CRA training courses at the extension college for the rest of that year. There is no substitute for experience so I had to be prepared to take a pay cut. I decided to approach it like going back to college. I couldn't exactly take out a student loan, so I just managed the best I could and made sacrifices like lowering my contributions to my 401K, living a little more meager, skipping Starbucks, etc. I read a lot of Suze Orman, complained to my girlfriends, and in time I had the experience I needed to merit pay increases and an eventual salary adjustment. I had to ask for all of these things, but fortunately for me, my bosses have been nothing if not overall fair and reasonable.

I travelled both domestically and internationally for that job and I loved it but my primary responsibilities were trial fiscal management, protocol development, and overseeing the contract monitors. I was so eager to be out monitoring more on my own that I moved on to a large CRO and now I travel all the time and love it! Ultimately I want to be an Independent Consultant and eventually provide more Sr. level CRA services. I know it would be a great gig for me because I am experienced in this industry, an excellent communicator, willing and able to travel, tech savvy, and self-motivated but that is still several years down the road.

I hope you find my story helpful if you are trying to get your foot in the door as a CRA. It took me several years of networking and determination but I am thrilled to pieces with my job and wouldn't trade it for anything.

You might be a CRA if...

So I am doing a little work this weekend and it reminded me of another email forward I received a while back so I am posting it for you all to enjoy:

You might be a CRA if....
1. You think working on weekends is normal.
2. You have ever used a bathroom on an airplane...to change clothes.
3. Crying babies on an airplane don't wake you up.
4. You have enough frequent flyer miles and hotel points to take the entire State of Montana on a free vacation.
5. You can pack a week's worth of clothes in one suitcase.
6. Something beeps or rings on you when the plane lands.
7. Half of your voice messages are from recruiters.
8. You can survive on a diet of peanuts, pretzels and soda.
9. You can recite the ''airline safety speech'' verbatim.
10. You silently laugh to yourself when you hear someone at the Atlanta airport say ''I can't believe we are going to be late again.''
11. You belong to every frequent flyer program and frequent hotel guest program in North America.
12. When it is time for you to buy a new car you don't have to test drive any because you have rented every type of vehicle available.
13. You know the three letter code for at least 10 North American Airports.
14. When you check in to the hotel the desk attendant says ''Welcome Home.''
15. You spend more time at the airport than you do at your desk.
16. You have two checking accounts...One for your paycheck and one for your expense checks.
17. You change time zones at least 2 to 3 times a week.
18. You get up at 4am to catch a plane for a business trip.
19. You can identify every major US city from 30,000 feet..............at night.

These had me in stitches but I can't immediately see the advantage of number 16. Please weigh in if it makes more sense to you. Let me know if you can think of a clever number 20 to add. I was thinking maybe something like "You know enough acronyms to create your own dictionary."

I promise to update the blog with more informative and topical posts just as soon as I get caught up with the stuff that pays the bills like finalizing monitoring visit reports and expense reports (I travelled 10 weeks straight with little to no home-office time) so please continue to be patient. ;)

Funny Things From Charts

Sitting in a room reading medical records can get a little dull but every now and then I come across an error or something that really makes me chuckle in the charts. A few weeks ago a co-monitor brought me a chart and pointed out this gem written during a Physical Exam: "Deaf in both eyes"


A friend forwarded me an email chain with some more so here is your chuckle for the day:

1. The patient refused an autopsy.

2. The patient has no previous history of suicides.

3. She stated that she had been constipated for most of her life, until she got a divorce.

4. Patient has chest pain if she lies on her left side for over a year.

5. On the second day, the knee was better, and on the third day it disappeared.

6. The patient is tearful and crying constantly. She also appears to be depressed.

7. Healthy appearing decrepit 69-year old male, mentally alert but forgetful.

8. She is numb from her toes down.

9. The skin was moist and dry.

10. Occasional, constant infrequent headaches.

11. Patient was alert and unresponsive.

12. Rectal examination revealed a normal size thyroid.

13. Both breasts are equal and reactive to light and accommodation.

14. Skin: somewhat pale but present.

15. Patient has two teenage children, but no other abnormalities.


Feel free to post a comment if you've come across anything just as silly - thanks!

Data Lock

Today we lock the database. Finally. I was brought on to this rescue study after conduct was complete; the other CRO had been fired and things were a total mess.  The final week was the longest yet, when I arrived on site there were still around 300 CRFs that had not been SDVd but luckily management sent in reinforcements. I was lucky enough to be joined by 2 excellent and experienced Senior CRAs and 1 very wonderful consultant CRA. It was a long week but the effort at my sites was extraordinary and we finished Thursday night ahead of schedule! We stayed late each night, I brought in lunch and caffeine so breaks were kept to a minimum, and I ran a lot of status reports and did a ton of cheer leading.

We tracked our progress on a white board and set and re-set achievable goals until all the work was complete. At the weekly sponsor call on Friday, everyone was singing our praises and stunned at the work we had done. My team assisted the site in resolving over 500 pending queries in around 3 days - a feat that nobody thought could be done so we surprised them all! I always was confident we would make the deadline because I had such a great team making the effort and the study staff was so motivated to meet the deadline. It was an eleventh hour delivery but we made it and we even beat some other sites to the finish line so that was satisfying, too!

I sent the other monitors home early and then stayed Friday organizing the source, pulling stickies and monitoring notes, giving everything a final glance, and helping the SC draft file notes. I also reviewed all of the ICFs one final time and ensured all the source was signed with complete headers. Everyone at the site pitched in to help and we had it all cleaned up in no time. I got home around 9pm on Friday night and spent the weekend watching TV and lounging around the house. I even booked a little trip for this weekend and then a mini-break in mid-December with some of my banked PTO. Now I just have to tackle my monitoring reports - yikes! ;)

I'm really happy with the site's performance at the end and the state of the source and the database now that we have locked. I'll return to my sites in January to perform the close-out visit and I'll inquire with the project team whether there are other sites that need a COV or monitoring support so I can help there as well. In any case, I'm eager for a little home office time to put my personal and professional life back in order - both have been on hold for about three months - but I'm so glad I had the opportunity to work on this exciting project. I like to think that you never get more than you can handle, and that the challenges along the way make the achievement at the end so much more rich and enjoyable.

I'll get back to posting here soon so please stay tuned and keep checking back. Thanks again for your continued interest!

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. ;)