Today in History (and TheLeadCRA.com blog traffic statistics)

On October 12th:

• 1792 – the first celebration of Columbus Day commemorated the 300th anniversary of Columbus' landing in the Caribbean in 1492.

12-Oct-1999: A teacup yorkshire terrier
named George (the author's favorite artist
from the band The Beatles) is born.

• 1850 – The 1st women's medical school, the Women's Medical College of Pennsylvania, opens.
• 1928 – An iron lung respirator is used for the first time at Children's Hospital in Boston.
• 1968 – The music single "Hey Jude" by The Beatles tops the charts.
• 1976 – The People's Republic of China announces that Hua Guofeng is the successor to the late Mao Zedong as chairman of Communist Party of China.
• 1997 – John Denver, American singer dies at the age of 52 in a private plane crash.
• 1999 – Sir. George Basil, a teacup yorkshire terrier is the only survivor in a litter of five (and subsequently adopted by this blog's author).
• 2010 – Returning via airplane to San Francisco with her boss after nine Site Initiation Visits in less than eight weeks, the blog author, NadiaBoBadia is offered (and accepts) a free upgrade to the First class cabin. Remarkably, NadiaBoBadia is still regularly teased by her co-workers for not agreeing to surrender the upgrade to her supervisor. 

12-Oct-2010: NadiaBoBadia enjoys a complimentary fruit and cheese plate,
watches some TV in her comfy First class seat, and sends a
free glass of wine back to her boss who has to ride in Coach.

12-Oct-2007: 
The Inception of The Lead CRA blog

Oh yes, and I almost forgot to mention that on October 12th, 2007 after 1.5 years working as an in-house CRA, I received an employment offer to become a Regional CRA and I launched "The Lead CRA" blog.  I have really enjoyed sharing my experiences these past few years and I am more committed than ever to maintaining and updated the blog.  

Today I am pausing to give a special thank you to my loyal readers; to both of you, thanks so much! ;)  I've made many new connections with other clinical research professionals, some virtual and some in-person, all priceless to me.

A Snapshot of Blog Activity to Date

Actually, the blog traffic has increased to the point that I have purchased my own domain, a server cloud, and considered relocating to Wordpress.  All that and the entire blog is still relatively small with less than 100 posts and pages published since inception.  Just in the past 12 months, LeadCRA.blogspot.com has welcomed 10,000 visitors (65% of the readers arrive via a search engine, 20% of the readers are subscribed or come directly through links, email, or referring sites).  Roughly 40% of my visitors are repeat visitors so I continue to strive to provide content that keeps you interested and encourages you to return.  

Google Analytics tells me visitors have arrived at leadcra.blogspot..com from 3700+
cities representing108 unique countries. I am surprised to discover that the content
has been translated into nearly 80 languages other than English. Wow!
(North America-54%; South Asia-11%, East Asia-7%; Western Europe-7%; SE Asia-4%...) 

These statistics may seem pretty pedestrian for any of the fellow geeks in the crowd, but because the content I write is very focused, specific, and niche, I'm really quite thrilled with the turnout.  I am grateful to have the opportunity to continue to author relevant and (hopefully) interesting blog posts.  Your comments and emails definitely keep me going, so let's continue to stay in touch.  I have ~200 all-time comments - thanks!

Since last Fall, I've received 75+ personal emails with feedback, suggestions, career advice/resume questions, and a variety of other reader-recommended topics.  You can read through the archives here. Thank you for your patience when I don't respond to email straight away; remember this blog is my hobby and not my day job.  Despite the fact that I still only update the blog just once or twice a month, the project continues to be fun and rewarding.  

What's Next?
I have some exciting new content planned for the blog and I am always open to ideas for new topics.  I'd like to see some of the content I have developed get published in a professional journal, referenced in other industry websites, or disseminated through other social channels.  Therefore, I am working on several of these efforts in parallel this Fall.  I hope you will continue to check-in (please accept a free subscription by clicking this link if you have not already done so) and I always encourage you to share LeadCRA.blogspot.com URL with other Clinical Research Professionals so that we can maintain and grow readership.

Thank you once again for following along!

ACRP The Monitor Magazine

The Association of Clinical Research Professionals (ACRP) has a very active chapter in San Francisco, California.  When I first moved to California and wanted to become a CRA, the local chapter assisted me with some helpful connections and networking opportunities.  I learned about a clinical research certificate program through a local university, attended seminars on clinical research topics and issues, and enjoyed various relevant educational events.

I've lapsed on my membership, I have not pursued ACRP certification, and I've never attended global conference, but I'm still on the mailing list. ;) Today I was cleaning up emails from the past few weeks (sorry readers, I have been slammed at work and I am over a month behind on correspondence - yikes!) and I noticed that the September Issue of the ACRP professional publication, The Monitor is offered for free online.

The September Monitor magazine topic may be of interest to many of you: Careers in Clinical Research.  It seems to be another terrific edition with a diverse group of authors and every article looks interesting.  Here is a sampling of some of the most relevant articles you can read in this online edition:

• I Want to Become a Clinical Research Associate . . .But How Do I Get My Foot in the Door? by Jill Matzat, RN, BSN, CCRA, CCRT

• The Seven Key Traits of the Great CRO CRA by Brenda Reese, RN, CCRA, BSN

• How Can Professional Development Advance My Clinical Research Career? (An Interview) by Esther Daemen, BSN, CPP, CPM, PG Cert Bus Admin (Open)

and more!

You may also like...from The Lead CRA archives:

• How to Break In To The Industry January 2009
• 5 Career Tips for a Young CRA July 2011

Lead CRA Q&A: Meeting with a Principal Investigator

Anonymous commented in... "Routine Monitoring Visits":
Could you please give advice about how to deal with the "difficult" Principal Investigator who doesn't want to meet you despite the numerous efforts to persuade him? Any recommendation would be very appreciated! -May 26, 2011 2:54 PM


NadiaBoBadia responds...
Thank you for a great question.  I've partially addressed it before in a post from the archives called "Who's Running this Study?"  Even though Principal Investigators (PI) have made a commitment to personally oversee the safety and conduct of the trial (In the US, see FAQ for FDA Form 1572) they often can't find time to actually meet with the monitors during our visits.  This happens quite often so I definitely want to address your question.  Remember, that there is no regulatory mandate that we talk to the PI but certainly it is a best practice.  However, I don't want to understate the importance of regularly briefing with the PI.  Remember from my post on Routine Monitoring Visits that the PI discussion is an opportunity to address important topics that affect conduct, can positively impact data reliability and validity, and ensure vigilance in reviewing ongoing subject safety.  If your trial is still recruiting, meeting with the PI can be instrumental in influencing study enrollment (related post).

My interest when I am monitoring is to meet all of my objectives as efficiently as possible and leave the site as soon as I have met my goals.  Guess what though, doctors are busy.  In turn, I offer my PIs flexibility where I can.  I do not insist that they drop everything and meet with me each visit.  Generally, I have more success when I schedule an appointment time (say 15-30 minutes) in my confirmation letter and confirm it a few days before arriving.  If the PI truly can't meet though, a telephone contact within 10 days of the visit will be an effective alternative for communicating important findings during the visit, pending items for resolution, or general study updates or training.  I document the call in my report, in a separate telephone contact report for the TMF, and/or an email recap.

Trick your PI into a meeting! Tell the
doctor there is a party they must attend and then tackle
them with your visit findings - just kidding!

Part of our goals as monitors are to prepare PIs for audits and also to influence operations of a trial.  We help bring corrective action for any missed procedures and help them document anything that may need to support the record of conduct down the road.  We help them defend their data and demonstrate that patient safety is protected.  The PI meeting furthers these goals so it is important to budget time for it.  Don't use the meeting just to criticize the "difficult" PI and the study site staff.  Give them kudos and tell them what is going well and also where improvements may be needed.

If you pitch the PI meeting like this, act accordingly, and are respectful of the PI's time then the meetings are more productive and more likely to occur.  As you build a relationship with your PIs, they will see that you are committed to helping them conduct the trial properly.  As your PIs grow to trust you as a partner to their site, they are more likely to make time to meet with you.


Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.



You may also like...from The Lead CRA archives:

• Selecting Qualified Investigators April 2010
• Pre-Study Visits January 2008

5 Career Tips for a Young CRA

I came across a fun little article on biospace that offers career advice: 5 ways to be a rockstar at work (via Biospace).  

This post echoes the format of that article and I hope you will find it interesting and leave me a comment or email some feedback. 

Although I have transitioned to in-house, the bulk of my experience as a CRA is in Regional Monitoring.  Reflecting back on the career tenants I stand by, I am sharing today my 5 best career tips for a new travelling monitor.

1. Be a Partner

• An auditing approach to monitoring will strain your relationship with the site staff.  You know the regulations that govern our work and you understand the study that you are monitoring including all the expected procedures, assessment windows, and special instructions provided in newsletters and in other study correspondence.  Your attitude can be to train the study site personnel and share with them this information to help them protect subject safety and data integrity, or you can go in and point out everything they’ve done wrong and focus only on the poor performance.  You can write a damaging monitoring report, cover yourself, and simultaneously ostracize the site but you will not have partnered with the site or introduced extra quality; you may be perceived as a bully or hall-monitor.

• 

  Don't "police" your sites too strictly.

  This approach is detrimental to

  quality relationship building.

  Remember that coordinators and Investigators have responsibilities beyond your specific trial.  I have addressed this in other posts such as 'Motivating Your Study Coordinators'.  If you can’t put yourself in someone else’s shoes you won’t be able to influence them to help you with your goals during the visit or in future visits.
• At crunch time you will cultivate the relationships you have built. Need access to the site at a greater frequency or increased duration?  Need your coordinator to stay late and do some extra data entry or query resolution?  If you have been friendly and respectful to date, you improve your chances of getting what you need out of your sites – even at short notice. 

2. Know your Metrics / Deliver Quality Results

What is expected of you? How do you
rank in performance compared to your
peers?  Are you accountable at work?

• You are being measured against your peers.  Approach your work in a task-oriented manner and ensure that you know which deliverables are due, when, and in what manner.  Deliver early and track your contributions. 
• Be current on all training and don’t expect a prize for meeting this basic job responsibility.  Even if “nobody else is getting their SOPs done”, stay current on yours and don’t link your performance (or failure to perform) to others.
• You’ll come to find that cultivating quality relationships and trust with your sites will go hand-in-hand with producing excellent metrics.  Focus on quality first and the metrics will follow. 

3. Raise your Flag / Get Noticed

Me me me.  Don't forget to highlight the successes
 of your supervisor and the collective team.
Contributing to other people’s happiness
 and “ team buzz” will return to you in dividends. 

• Pause and reflect as needed to appreciate your body of work.  I keep a “praise” folder in my email to store thank you notes and stories of major deliverables I have met or produced.  I reference the “praise” folder as a pick-me-up when I am feeling overwhelmed and challenged.
• Since you are always identifying your deliverables and finishing everything ahead of the deadline and tracking your contributions as I have suggested, you can provide this information to your immediate supervisor at 1:1s, in performance reviews, or in status report emails. 
• Don’t overreach.  If you are promoting yourself to your bosses boss, you may be overstepping and actually undermining your current boss or creating animosity among your peers.  Tread carefully here.  Be humble and use good judgment.  

4. Don’t Commiserate / Nobody likes a Debbie Downer

Moaning about what isn't working is easier
 than focusing on what is going well or
coming up with solutions to improve
 situations that are not ideal.
Resist the temptation to commiserate.

• Your peer CRAs may live and work in cities far away.  They will have different financial circumstances, family backgrounds, tastes and preferences, and values.  Typically the easiest common ground when forging a relationship with your peers is to talk about work and the projects at hand.  Inevitably, this will lead to grumbling or complaining about the demands on your time, or a boss who just doesn't get it, or a lead who seems checked out, or a site that is difficult to work with.   You may feel you are “just venting”, but negativity is toxic, counter-productive, and a bad attitude will adversely affect your future career prospects.
• If you have nothing nice to say, don’t say anything at all.  In every job you have to evaluate the gap between what you want from your ideal position and what you have in your current position.  It is your charge to reconcile that gap by identifying concrete and measurable outcomes that leave you satisfied.  If you simply cannot overcome the gap because of a corporate culture mis-match, timing, resourcing restraints, etc. you have to decide 1) Am I going to acclimate and deal? or 2) Am I going to bolt?  You should only be asking those two questions once you have exhausted every avenue to change your position into what you want.  These are the only two choices.  If you take things to their natural conclusion, you can stop being petulant and accept your circumstances or you can have the maturity to leave your position; either option is ultimately in the best interest of yourself, your boss, the organization, the sites, and the study patients that we are ultimately responsible to.  The scenario where you stay begrudgingly, and half-perform will likely eventually result in your termination. Your metrics will suffer, your relationships outside the office will be impacted, and you will be unfulfilled and miserable at work. 

5. Be Patient  / Exercise Humility

The best managers teach you that
you can validate yourself and
recognize your own accomplishments.

• Your Lead CRA isn’t approving your trip request within two hours of submission? Give it at least a day and recognize that you are one of a team of many CRAs that your lead manages.  This, while your lead simultaneously juggles all of the other CRA Lead and ad hoc responsibilities.  Trust that your request is in the queue and chill out. 
• Not getting the promotion you are ready for or the recognition you want after over-delivering on an important study milestone?  Keep reminding your supervisors of your contributions through status reports, performance evaluations, in 1:1s, or in a team setting. 
• Great managers always have a pulse on your contributions.  Better managers always give you credit for a job well done.  The best managers provide acknowledgement strategically; they make you wait for it to teach you humility, maturity, tact, and solidify your role in the organization.  The quality expectations are very high with the best managers and therefore they reserve praise for only truly exceptional performance.  Feedback that you have to be patient for will prove to be your most valued feedback at work.

You may also like...from The Lead CRA archives:

• How to Break in to the Industry January 2009
• Challenges to a New CRA May 2009
• Negative Performance Feedback April 2010

Summer Vacation

I hope everyone has exciting plans for the summer or at least a plan to beat the heat.  Temperatures in San Francisco were almost 75 degrees Fahrenheit this week.  I don't have air conditioning and my home is in the upper level of a beautiful Edwardian building...at the top of four flights of stairs, this has been a scorcher by SF standards.  ;)

I've planned a lot of exciting content for the blog in the coming months so I hope you will continue to follow along.  I've invited several guest contributors to help generate topics and content; I really can't wait to share some of the series' we have come up with so please stay tuned.

I will visit Guangzhou, Dali, and Lijiang this summer.
I had to get a new passport and visa because I ran
out of space in my old one - can't wait!

I am planning a vacation to Hong Kong and Yunnan province in July but I'll queue up some posts and address your comments and questions as I find time.  I've been corresponding with many of you via email but I have been on a bit of a hiatus from the official Lead CRA blog due to a lot of competing priorities at home and work; I'll include some of the topics of broader interest here for your perusal very soon.

Thanks again for your loyal readership.  You can always reach out to me in the comments section of any post or email me at leadcra-mail@yahoo.com if there are items you would like featured or if you have any monitoring questions.  Here's to a wonderful summer for all you hardworking clinical research professionals!