CRA Orientation and Training

I have been a Clinical Research Associate (CRA) for three years, but I recently accepted a new CRA position and thought it would be helpful for me to explain the on-boarding process. Whether you are working for a CRO, pharma/biotech, or as a consultant, there is always new hire orientation and training to complete. The…

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Hard Times Right Now for a CRA

I received my formal performance review last week and an overall rating of “Exceeds Expectations” with some great input from past Project Leaders/peers and highlights of some of my more notable accomplishments in 2008. I was unprepared for how well I ranked on my metrics so I will keep a closer eye on that in…

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Close-Out Visits this Quarter

Close-Out Visit keeping this CRA busy I’ve been performing close-out visits for a variety of studies lately and I am ramping up on a new study. Sorry I haven’t been able to post sooner, but in this economy I am happy to have a great job that is keeping me busy with such interesting and…

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How to Break In to the Industry

So, you want to become a CRA? Sure you’re bright, astute, willing to learn, and capable, but getting your foot in the door in this industry can be a real uphill challenge. I know you will find your path, but I can offer some tips and advice to hopefully help you. If you are interested,…

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Data Lock

Today we lock the database Finally, data lock 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…

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Monitoring Visit: What to Pack

what to pack for a monitoring visit

I came across a nice online article recently by Greig Waddell with tips on how to save time when traveling for business. Click here to check out the full article. I thought all of his points were great but I wanted to expand upon it a bit in the context of traveling to a monitoring…

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Efficiency Tips: Spend less time on Monitoring Visit Reports

Many Protocol and Many Monitoring Visit Reports Draft Monitoring Visit Reports before you even arrive on site As a monitor, you may visit several different study sites in a single week and possibly for different protocols. I often find when I get home from a trip like that it is hard to write my report…

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Efficiency Tips: Spend less time on Expense Reports

I pay for most things with my American Express (Amex) but I am required to submit receipts for all charges over $10. We either scan our receipts in and attach them through the web browser to a pending report or we fax them to a dedicated fax # with a spiffy system-generated coversheet that accomplishes…

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Efficiency Tips: Spend less time on your Timesheet

I am employed by a service company and we bill our clients for our services. Therefore, we must track our time spent on sponsor related work and pass the costs through appropriately. I am asked to track my time in 15 minute increments so I can basically report up to 4 time categories per hour…

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Close-Out Visits

closeout and archive files

I’ve done about 10 close-out visits in the last few months so it feels like a good time to write a short article explaining what the objectives of these visits are and how a typical close-out visit (COV) is conducted. Clinical Trial Site Close-Out Visit A close-out visit will occur once subjects are no longer…

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