New Year, New Destinations, New Perks?

I'm out on my first work trip of the year performing a few Site Initiation Visits for a new drug study in Southern California.  I've definitely logged some serious miles flying SFO->LAX in my time monitoring but hopefully I'll have more sites soon in some locations that are new to me (but not anywhere it is snowing...fingers crossed).  So how do I keep my trips from becoming too routine and how do I avoid travel burnout?

In every city I seek out interesting new restaurants to try and explore the area as much as possible when I have to overnight.  I'm fine to dine alone or go to a movie alone, and I rarely if ever take meals at the hotel.  For restaurant recommendations, I research on the internet, ask my site personnel for tips, or I use an iPhone application like Urban Spoon or Yelp to get my bearings.  Last year I earned 20,000 miles on my preferred airline just by dining at restaurants they recommended on their website and for registering for all the promotions (that is basically a free roundtrip ticket in the US, so not too shabby just for routine within policy dining).  If I have a fabulous dining experience I will review it on the internet but I rarely dine again at the restaurant - I just love trying new things and find that a great dining experience is always better in your memory than when you return and try to relive it - it just never seems to meet my expectations the next time.

I always have my camera ready in case I come across anything out of the ordinary.  When I see this cactus I remember a visit I did to Tucson, AZ. I was bored one evening so I went and found a new hair dresser.  Her name was Aqua!

I also love it when I visit the city of a friend or co-worker and we can meet up for shopping, touring, or dining after work.  Viewing a city with a local's perspective is such a wonderful opportunity and I am lucky to have met up with friends and family at various times while on work trips in the past.  I've even been known to have buddies from home tag along and kick back around town or in the hotel while I am out at work all day.  Then in the evenings we meet up and check out the city together.  These trips have all been so memorable and special for me and I'm lucky to have a great job that allows me to travel and have so many wonderful experiences.  Maybe I'll feel differently in 5 or 10 years but for now I am not road-weary at all.

I can't recall whether I have mentioned on the blog before, but one wacky thing I do is to stay in a different hotel every night.  This is one part for safety, one part so I don't get bored, and one part to satisfy my lust for hotel points and miles (top tier loyalty program status is awarded based on number of stays so if I am in a city for 3 nights I will stay at 3 hotels just to race to obtain the highest status - once obtained I challenge in a different hotel chain or chase hotel promotions as they come along).  Most monitors I talk to about this just shake their head in disbelief and laugh, but I just can't imagine staying multiple nights in the same hotel - that is really not for me.

My favorite part of travel are the unexpected perks and little upgrades and freebies along the way (no, I don't mean hotel soaps and lotions - oh but I still collect them sometimes when they are really nice - but how many of these can a girl really use?).  I like the little things, like an extra bottle of water in my hotel room, or a fuzzy robe and slippers, or the radio on when I enter, a call from the front desk to check that everything is satisfactory, or chocolate truffles on my pillow - yum!  At dinner last night I was given an ocean view table, the waiter addressed me by name, and he treated me to a free dessert.  Occasionally I'll get a snazzy complimentary upgrade on the flight, at a hotel, or in a rental car.  I especially love upgrades or token gifts that are unusual or surprising.  Last year for my birthday my regular taxi driver suggested a San Francisco restaurant to celebrate with my friends.  He made the reservation and arranged for gratis champagne waiting upon my arrival.  There are sacrifices for being away from home so often but I appreciate how the little gifts help keep things in balance and fun.

This free fruit basket was provided in my room at the Universal Studios Hilton in Los Angeles because I was staying there very often.

A Doubletree in Denver gave me some trail mix and cookies
to go with my free bottled waters.

Happy New Year everyone!  Here is to a 2010 filled with many exciting new destinations (or new looks at old ones through new hotels and restaurants to try) and many many perks along the way.  Leave a comment and let me know how you have been rewarded in your business travel or how you avoid slipping into a routine while out on the road.  Safe travels!

ICON Warning Letter from the FDA

Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials.  My understanding is that the sponsor submitted the NDA, triggering routine inspections, and the CRO has now been asked to respond to a series of serious findings.  There were reportedly issues in regards to storage/dispensing of investigational product, protocol deviations, incomplete source documents, inadherence to the monitoring plan, and insufficiency in monitoring oversight.  It is a very detailed letter and appears to question whether 100% Source Data Verification was completed properly with a series of concrete examples of discrepancies.  As monitors, we need to comply with all regulations and stay abreast of these kinds of relevant FDA findings - hope you will find reading the warning letter as helpful as I have.  Here is the link again: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm193156.htm 

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 CFR and ICH/GCP require drug companies to ensure that the monitors like me are qualified by training and experience. In order to demonstrate our compliance we must document that training. Our expertise is also documented in a signed copy of a CV.  Finally, we typically sign and date a copy of our company furnished Job Description to be saved in the training or employee files that serves as an acknowledgment that we understand what is expected of us in our role as a CRA.

I blogged a few years back about my experience in my last New Hire Orientation but I will elaborate today on what types of Standard Operating Procedures (SOPs) and training courses a CRA might reasonably expect to complete at any company. So the important thing to note is that you repeat some form of this training at any new company whether you have one year experience, five years experience, or twenty years experience.  In fact, even within a company you may find that you repeat these trainings annually or periodically - this protects you and the company because you have a documentation trail demonstrating your qualifications to monitor clinical trials.

Everyone signs off on the required training before they step foot into a clinical site. This protects you as well so be wary of any company that wants you to go out and monitor without proper training and qualification documentation in place - it really can be a risk for you.

Companies typically offer new CRAs administrative training, regulatory/procedural training, and project specific training.  Trainings can be administered via a traditional classroom setting, via webinar/teleconference, over the internet using recorded playback sessions, in person, or on-the-job.  Obviously there are pros and cons to the different formats (opportunity to clarify and ask questions, assess understanding, consistency of training delivery, level of interactivity and engagement, etc. but that is a bit off-topic for this post).  Irregardless of the format, at the end of each training some documentation is typically generated and signed (may even be signed electronically) to detail who led the training, who attended, the topics covered, and the date of the training.  You may be in training for a few days or even a few months.  The formality of a new CRA training program is very company specific but I am going to attempt to generalize the three categories of required training that I have experienced.  This is not exhaustive and certainly these may not all apply to you:

CRA Administrative Training
General: How to Order Office Supplies, Completing Timesheets, Expense Reports, Travel Policy

Information Technology (IT): Accessing the Computer, Intranet and Email Policy, Company Specific Websites or Applications, Using Microsoft Outlook/Lotus Notes, Setting up Voicemail and Email Signatures, Electronic Data Capture (EDC) System

Human Resources (HR): Company Overview, Employee Benefits, Performance Review and Employee Development System, Ethics and Compliance, Insider Training, Conflicts of Interest, Privacy Policy, Dispute Resolution, Harassment/Sensitivity Training, Ergonomics, Workplace Safety

Regulatory Procedural Training
Regulatory: 21 CFR 312 & 812; 21 CFR Parts 11, 50, 54 & 56; ICH/GCP; Good Documentation Practices; HIPAA/Confidentiality

SOPs: Informed Consent Process, Investigator Site Selection, Pre-Study Selection Visit (PSV), Site Initiation Visit (SIV), Routine/Interim Monitoring Visit (MV), Close Out Visit (COV), Source Document Verification, Record Keeping and Retention, Electronic Signatures, Fraud and Misconduct, Protocol Deviations, Audits, Inspections by Regulatory Authorities

Project Specific Training (may overlap SOP and general training)
Writing a Monitoring Report
Monitoring Plan
Trial Master File Maintenance
Completing Site Contact Records
Case Report Form (CRF) Completion Instructions
Integrated Voice Response System (IVRS)
Using Diaries, PDAs, or other Patient Reported Outcomes (PRO) Instruments
Protocol Training
IRB & Regulatory Submissions
Study Budget
Investigational Product Handling and Accountability
Randomization and Unblinding
Study Supply Management
Serious Adverse Event (SAE) Reporting

I hope this overview was helpful. I am happy to expand on any of this - just comment or email to let me know if you have follow-up questions.

US Clinical Researcher Competition

Have you been to a dream clinical research site? Do you know an excellent Study Coordinator that you would just love to work with again? Did you work on a project that was run so beautifully that all important milestones were delivered ahead of time and under budget? Perhaps you know a CRA who just excels at the role and has given you inspiration and valuable tips and training?

PharmaTimes, an industry specific news content service is hosting their first ever US Clinical Researcher Competition. There are 4 categories of awards including Study Coordinators, CRAs (less than 4 years experience and Senior CRAs), and Project Managers. Nominations and entries must be in by November 9, 2009 and winners will be announced in the spring of 2010. Here is a link to the contest website:

http://www.usclinicalresearcher.com/default.aspx

I've been monitoring for 3 years and there are a handful of truly memorable and outstanding professionals that I've had the opportunity to work with. I was delighted to hear of this new contest and I put in a couple of nominations as a nod to some of the fabulous folks I have come across. Here is the form to nominate in case you would like to do the same:

http://www.usclinicalresearcher.com/NominateColleague.aspx

Lead CRA Q&A: Am I getting a bad reference from a previous boss?

Anonymous said...

Hi, thank you for the advice you offer in your blog. Just a small question, I was referred for an interview at an international pharmaceutical company. I passed the first interview and was asked to have psychometric test which I was prepared for by a psychologist. They probably called my previous boss and after all that I received a negative response. This is the second time that I miss a good position after she was called. What do you think I should do? I have a lot to contribute to any firm, I just can't find them. thank you Y.S -September 3, 2009 6:46 AM

NadiaBoBadia responds...

Hi Y.S., and thanks for your question. I am sorry to hear that you were passed over for an opportunity that you were interested in. I am a very firm believer that things happen for a reason and I hope it will be of comfort to you to think that missing out on this particular job(s) leaves you available to find one that will be an even better fit and more rewarding experience. You would like to know whether you failed to land these positions because of your performance at the interview, due to results of an interview assessment, or because of a bad reference from a previous boss, or even a combination of any of those three factors.


You do have some control over the success of the interview. Please review my interview tips so you are always prepared - by knowing what to expect you are most likely to perform your best. To your second point, I have never been given a test or a psychologist assessment (to my knowledge) at an interview so I am not in the best position to give you advice. All I can say is that in the US we have laws that protect us from discrimination and you should always have your radar up for illegal interview questions and practices that may be used to exclude you. I am not speaking from a legal reference here, but I believe that if you agree to submit to the test you are consenting to the results potentially being used against you and you just have to either be at peace with that or decline to move forward.


In regards to your final concern, you are wondering whether a previous boss is sabotaging your success during the reference process. There is no requirement that you must give a prospective employer your former supervisor's contact information and I might advise you not to do so if you are worried about this particular reference. Providing a reference may be a condition of employment and withholding references will be a huge red flag to the hiring company so simply offer an alternative reference instead - someone you trust more, even if they weren't your line manager perhaps they had some less dotted-line supervisory experience with you.


Ask permission from all your references, provide them with a job description, and email them a bulleted list of 3 or 4 of your major recent accomplishments or strengths. This will help them prepare and promote you to the new company. Maybe your old boss isn't saying anything hurtful they are just blind-sided by the reference request and have no idea how to help you or what to say. In any case, I do recommend you have a conversation with that person before you consider providing their contact information to a potential employer again. I will point out that many large companies have a policy that managers may not provide references for liability reasons. Your former boss may have been instructed by HR only to verify the dates of your employment and not to comment at all on your performance.

Try not to take rejection too personally.

Today there are many qualified candidates seeking positions and the competition is stiff. A firm may look at 5 fabulous job seekers, any one of which would perfectly suit the role but they can only choose as many as they have requisitions for. Therefore, perfectly good candidates will regularly be turned away. In other words, not receiving an offer for the job doesn't necessarily mean you wouldn't be great for the job or that you did anything wrong at the interview. Finally, you can't force an offer, sometimes they just aren't going to love you and there is nothing you can do to overcome a lack of fit. Personally, I'd rather focus my energy on finding a great job where my unique talents are really appreciated than muddle through in an OK job where they weren't super excited about me as a candidate in the first place.


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.