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Wednesday, August 14, 2013

Let's All Move to the ClinOps Toolkit Now

The Lead CRA Blog is Moving to a New Home: ClinOps Toolkit

Thanks for visiting here, following along on Facebook and checking out the new blog project, ClinOps Toolkit.  Have you joined the Members only discussion Lead CRA group on LinkedIn?  It is especially for CRAs, private, and free. Join today!

Are You Subscribed to Posts Via Email?

If you have previously subscribed to my feedburner email service, I'll be sending you an invitation to opt-in to the free ClinOps Toolkit new subscription list.  Emails from the Lead CRA blog will not continue after August.  You can follow at the ClinOps Toolkit moving forward:

The Lead CRA archives and comments have already been ported to a new home at ClinOps Toolkit.  I will be redirecting all web traffic to the new site. If you have bookmarked any of the content here, your links may not work after August.

Thank you again for your support and continued readership over the years.  I look forward to continuing the exchange of conversation on the new blog, ClinOps Toolkit.
OK now, we're packed and ready to go. Let's all move to the ClinOps Toolkit!

Monday, July 15, 2013

The Lead CRA is Moving

I'm Relocating the Lead CRA Blog

If you are following along on Facebook then you probably already saw the announcement that I am moving the Lead CRA archived posts and as many comments as possible to my new blog project, ClinOps Toolkit. Don't worry, I want you to move with me.  Everyone is invited, let's go!

Please be Aware that Automated Emails Will Not Continue

If you have clicked follow or subscribed to my feedburner email list at some point in the past, then you may only hear from me a few more times via those services. I do plan to shut down the feedburner service in August in favor of a new free mailing list that offers enhanced templates and targeting so I can deliver the content that is better-tailored for you moving forward, but only if you opt-in to the new subscription list.

What do I Recommend For You? Re-subscribe.

If you would like to receive future posts via email you will need to sign up to the new subscription list that I created.  It is free, quick, and you can modify your preferences or unsubscribe at any time.

See You Soon in Our New Home!

As always, you can contact me via email if you have comments, suggestions, or ideas for future posts. I've got some ideas planned for August and you can follow along as my guest contributors and I publish new monitoring topics at the ClinOps Toolkit.

Much of the content here will be moved permanently to the enhanced blog and I will be redirecting web traffic to the new site. If you have bookmarked any of the content here, your links may not work after August.  Please be advised that I will redirect many of the links but some will likely become broken and inactive as I thin out the archives.

Thank you for your support and continued readership over the years.  I look forward to continuing the conversation on the new blog, ClinOps Toolkit.

Tuesday, June 25, 2013

Do you know a CRA Rockstar, a Super Study Coordinator, or an excellent PM?

Tell Them About the US Clinical Researcher of The Year Competition

The US Clinical Researcher of the Year competition has been accepting nominations since March.  They will continue to accept nominations until September, but why wait?  Nominate someone today who works hard in Clinical Research and deserves to be recognized.  There are separate categories of awards for CRAs, Study Coordinators, Project managers, and Clinical Study Teams.

I participated as a contestant the first year of the competition so I am now happy to promote and endorse the contest this year to all of you.  I made valuable networking connections, felt recognized by my peers, and had a lot of fun.  It was an absolute blast and I even took home a prize! I'm lucky to have great people in my network and each year I have recommended others. In fact, I've had at least one colleague at the competition every year!

Three Steps For Nominees to Complete

Once you nominate someone they receive an invitation to complete a questionnaire and confirm their interest in the competition.  The questionnaire is role-based and evaluates basic functional skills and knowledge of the regulations and guidance's related to their job.

The next stage of the competition is the "Clinical Competency Challenge: This requires candidates to respond in writing in no more than 1,000 words to three category specific competency questions and one further question, which explores the candidate’s reasons for entering the competition."

Finalists for this year's competition will be announced in October.

When I attended the finals, I was given a written challenge exercise where the topic was provided but I had to prepare a short presentation and Q&A session to a panel of judges; my presentation lasted about 20 minutes and I had less than an hour to prepare. All of the judges were pharmaceutical and CRO executives and they were attentive and supportive. I was asked interesting and thought-provoking follow-up questions and I had a lot of fun. Then, I had the rest of the day to meet my industry-peers, explore the area (it was in Philadelphia), and sweat it out in anticipation of the results.

The final phase of the competition and the much-anticipated award ceremony (black-tie/tuxedo) will be held 7 November 2013 at the Executive Briefing Center, SAS Campus, Cary, North Carolina (my hometown - they should invite me to be a judge!).

Nominate Someone Today

Go ahead and use this link to nominate that awesome Study Coordinator you loved working with, CRA rockstars (less than 4 years experience and Senior CRAs), and/or Project Managers.

Do you deserve to win?

Well, why don't you prove it by nominating yourself!  This competition is open to US residents only - good luck!

Related posts from The Lead CRA archives:

Monday, June 24, 2013

Are you at DIA? #DIA2013

This weekend, many clinical research folks headed to Boston for the 49th annual Drug Information Association conference.  Although I didn't make it this year, I'd love to hear from you if you attended; especially if you are a Clinical Research Associate.

Is the conference valuable for CRAs?  Would you like to share some highlights of your experience in a guest post or comment here at The Lead CRA blog?

This weekend I kicked off a new blog series at The Clinical Operations Toolkit blog called "The Buzz" and I listed the posters, sessions, and workshops that caught my interest.  If you do go to the conference and attended any of these, I'd love to hear your impressions and takeaways here or via email.

DIA 2013 - The sessions I regret missing: Part 1, Part 2

Have a fun week at DIA!

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Thursday, June 20, 2013

The Lead CRA 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 be 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.  A section for Regulatory and Pharmacy along with an up to date copy of the Screen/Enrollment Log.  I also include 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 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 and you make your own work schedule.  What is your favorite thing to do when you are not on the clock?

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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