Who’s running this study?

I just received an interesting article from a colleague: http://www.tampabay.com/news/business/article463686.ece Was the Principal Investigator Providing adequate oversight? The article discusses a clinical research unit in Florida where the PI oversight isn’t exactly verifiable. This is always an issue for us as monitors, especially when the Dr. practices from one location and the study is conducted…

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Routine Monitoring Visits

Routine monitroing visits clinops toolkit

Routine or Interim Monitoring visits are basically any visit that occurs after the site is initiated and up until the site is closed out. As monitors, we visit our sites periodically to ensure that they are compliant with all the regulations, subject safety is being adequately followed, data is being captured in a timely and…

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Clinical Fraud Hearing Held Today

I received an email from my old boss today alerting me to an interesting webinar. I am posting it for other people’s benefit. She states “The webcast below is a hearing to explore fraud at a clinical site for a study conducted by Sanofi-Aventis. The hearing took place this morning. Interestingly, the CRO and the…

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What to Expect at a CRA Interview

What to Expect at a CRA Interview_feature

I’m posting to let you know what kinds of questions you might expect to be asked during a CRA interview. Practice these in the shower, in front of the mirror, or with a friend so you are prepared! Typical Questions Here are general questions that you will likely be asked with tips for answering shown…

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Home from the Investigator’s Meeting

I’ve been assigned another study and attended a kickoff and Investigator Meeting on the East Coast last week. As I mentioned in my last post, an Investigator’s Meeting is basically a chance to get all the doctors and staff together at one venue with the sponsor (usually a fancy hotel or somewhere fun) so that…

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Pre-Study Visits and Site Initiation Visits

Clinops toolkit study monitoring visits and site initiation

Pre-Study Visits Depending on the company you work for and the Standard Operating Procedures (SOPs), you may be required to complete an in-person Pre-Study Visit (PSV) before an investigator is initiated to join a clinical trial. In some cases, you may even be able to perform this via telephone, web-conference, or it might be waived…

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Introduction to Monitoring

monitoring tools to save you time

I’ve been out on the road for the past few weeks assisting some other monitors to review patient’s medical records and the data that has been collected for the clinical trial. It occurs to me, that it would be beneficial at this point to further describe to you the roles and expectations of a Clinical…

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Staying Flexible and Creating my CV

Working at home isn’t all bad but I have to stay focused and shoo off distractions like my little yorkie, George. I have been kicked back at home in my bunny slippers pouring through the SOPs and online training courses for my new CRA gig. As of orientation, I was assigned to one study but…

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New Hire Orientation

New Hire Orientation for a Clinical Research Associate Day One of Orientation I have been at new hire orientation all week. We started at 8:30a on Monday with HR. They reviewed new employee stuff including company history, benefits, and general company information. I was greeted at lunch by two long-time employees who took me out…

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The Offer(s)

pros many, cons any?

I’m sitting in the airport heading home from my interview. I hope this will be the last interview for a while. Every 6 months I get the urge to switch jobs so I finally just chose a job that changes every 6 months, Clinical Research Associate (CRA). A CRA is responsible for traveling to MD…

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