The Lead CRA Interview with an Independent CRA

Annmarie loves boating on lake michigan when she is not busy as a CRA

An Interview with an Independent CRA

The Lead CRA asks: Annmarie, when you show up on site you always have your objectives planned out. What kind of prep work do you complete prior to visiting a clinical site for the first time?

Annmarie: I send a detailed confirmation letter indicating my goals and expectations. So that the site clearly comprehends what will occur during the visit.  I also generate a site folder that is specific to the site.  Within this folder there is a section for site location/staff contact/lodging.  I also include sections for Regulatory and Pharmacy along with an up to date copy of the Screen/Enrollment Log.  I have a section for correspondence that I might want readily available and on hand.

Dress like a professional.  You are representing the company and you are a reflection of them….”a pet peeve of mine”!!!!

After the first visit is done, what kind of monitoring visit preparation is required for interim monitoring visits?

I prepare another detailed confirmation letter that clearly specifies the date* and time of arrival to the site and departure, objectives of the visit, and outstanding action items that need to be resolved prior to my departure.

*It is important to reserve enough days during the visit to accomplish all required and planned activities.  I typically confirm all my routine monitoring visit before departing the site at the conclusion of every visit.

 Now that I have met the staff in the previous visit. I put a lot of thought into my “communication techniques” that would work best with the personalities of the site staff in order to successfully accomplish my goals for the visit.

Be nice…you are part of a team (or an additional set of eyes) that only wants to ensure that the data is clean and that the subjects are safe. Presenting yourself in this manner will make the site staff want to work with you and for you.

You enjoy a lot of flexibility as an Independent Consultant and you make your own work schedule.  What is your favorite thing to do when you are not on the clock?

Annmarie loves boating on lake michigan when she is not busy as a CRA

I love being a wife and mother of 4.  My kids range from 25 down to 13.  We are avid boaters and live on our boat all summer long. What I consider “my time” is yoga, running and when I take long walks with my 150lb Newfoundland dog named “Bella”.  For whatever reason she really relaxes me after a long hard day.

Your business is all about referrals and personal connections, any networking advice?

Integrity is the key. Only recommend, work, or refer someone that you hold in high regard because Monitoring is a very small world. The people you affiliate with are a “reflection” of you.

Special thanks to June’s first guest CRA blogger, Annmarie Schaden, RN, CCRA.  Annmarie is a talented Senior CRA independent consultant for hire residing in Michigan.  She is a brilliant monitor with special expertise in monitoring early phase, Phase I units, CNS, cardiovascular, HIV, infectious disease, and oncology trials.  Annmarie is a licensed nurse in Michigan with extensive experience in pulmonary/cardiac medical and surgical intensive care, the Emergency Room, and home health care for oncology and pediatrics.  She is a member of DIA, ACRP, and ANAC and she is recommended by The Lead CRA.

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About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.