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Thursday, May 14, 2009

Lead CRA Q&A: Challenges to a New CRA

One of my connections is taking a CRA Development course and her homework assignment was to ask a tenured CRA "What did you feel were the biggest challenges of the position when you first started?" I am providing my answer and would love to hear if other seasoned CRAs agree or if there are other hurdles that I didn't even mention.

My answer:

When visiting a major medical center it can
be a major challenge just to figure out the
parking or navigating the campus (pictured: UCLA).
I am not a nurse and I have never worked with patients in a clinical care setting so it was a challenge to learn how office and hospital charts were organized. You have to know what is supposed to be in there in order to recognize what is missing. On the flip side, there is a lot of stuff there and you need to be able to figure out what is noise and what is actually important in your role as a monitor and the context of the study. Charts are sometimes hundreds of pages long and I have worked on studies where it took 2 days just to perform chart review on a single patient. Again, developing that skill to filter what is important and needs to be in the database versus what is just extra information is really critical to your success. Once I started on in-patient studies I also needed to learn how to read surgery reports and hospital medication administration records and the slew of acronyms and institution specific items that accompany both. I'm still learning, every time I go to a new hospital or study center. Charts are organized similarly but there are always institution specific nuances and learning how to read the charts is one of my main objectives at my first monitoring visit to each new site.

When reviewing AEs, labs, and Con Meds, you frequently come across things you are unfamiliar with. It was important when I first started to be industrious and know where to find answers. You can't possibly know everything but you have to be able to use your resources like Wikipedia, Epocrates, Merck, study staff, extension courses, and other training databases/materials provided by your employer or the sponsor to fill in those deficiencies as you come across them. You can also better prepare for a new study by doing internet research on the therapeutic area. On a recent study, I downloaded medically relevant podcasts to help me prepare and learn some of the common issues and medications with my patient population. When you are learning about a new therapeutic area, start with patient advocacy or education websites because they are nonscientific and then work your way up to journal articles, sponsor slidedecks, the IB and more intense material.

Finally, it is important to find the right balance when writing your monitoring reports. You want to give enough information and specifics to show you were there and followed all relevant SOPs and guidelines but you want to keep it succinct and avoid a novella. You also want to cover yourself in an audit later but different sponsors want different levels of detail. Your Lead CRA and Project Manager will help you land on the right amount of detail through their reviews but the first couple reports on a study are always a challenge because of this issue. You can read more on my blog about efficiency tips, timesheet tips, MV report tips, and Career Advice.

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