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Thursday, January 15, 2009

New Year - New Phone

So I just got the iPhone...I am a gadget geek so I believe I am really going to enjoy this thing. I am not really planning to integrate with my work email (maybe just my contacts) but I definitely think I can use it on the job in other ways. I went to the app store and found a few gems that should actually help me when I am out monitoring.

  • Weather - This is a standard app but you can add as many cities as you like so that is super helpful when you are packing for a trip!
  • Clock/Timezones - Also a standard app but I have sites in multiple time zones so this will be great for when I am making phone contacts and don't want to call too early or too late.
  • Epocrates - Information (and pictures!) of generic and brand name drugs. Although it isn't super relevant to my job, my favorite feature is the 'pill finder' where you choose the color and appearance of a medicine and the app recommends which drug you might be describing.
  • Units - easily switch lbs to kgs, etc.
  • Google Earth - Plug in all your sites and...well, I don't know if this will help me do my job but it is a fun app!
  • Yelp - This user-based community can give you recommendations of great restaurants in most metopolitan areas and help you avoid the bad places.
  • SC Zap - this handy app turns your iPhone into a tazer and when you're on-site but your Study Coordinator isn't cranking out the query resolutions fast enough you simply apply positive reinforcement with a little jolt of electricity...Just kidding - you would definitely need some serious Informed Consent for that one!!
So I have my apps and I can't wait to get back on the road again now that I am geared up. How cool will it be to effortlessly have internet access everywhere when I travel and check-in for my flights exactly 24 hours in advance to get the best seats!?!

Shoot me an email or leave a comment here if you are an iCRA and you have found other handy apps to recommend.

Monday, January 12, 2009

Performance Review Time

First quarter at my company means performance review time. Today I was asked to write a self-assessment of my 2008 performance so I read through cherished old emails from project leaders and peers (I keep these in a special folder called 'praise/review time'), jotted a few notes about my accomplishments, and finally searched the internet for inspiration. So here are a few gems I came across on a humor site:

"Since my last report, this employee has reached rock bottom and has started to dig."
"His men would follow him anywhere but only out of morbid curiosity."
"This associate is really not so much a has-been, but more of a definitely won't be."
"Works well when under constant supervision and cornered like a rat in a trap."
"When she opens her mouth, it seems that this is only to change feet."
"He would be out of his depth in a parking lot puddle."
"This young lady has delusions of adequacy."
"He sets low personal standards and then consistently fails to achieve them."
"This employee should go far -- and the sooner he starts, the better we'll be."
"This employee is depriving a village somewhere of an idiot."
"This employee should not be allowed to breed."
"This man has the whole six pack but is missing the plastic thingy that holds them all together."
"He certainly takes a long time to make his pointless."
"He doesn't have ulcers, but he is a carrier."
"He would argue with a signpost."
"He has a knack for making strangers immediately."

Let's keep our finger's crossed that I get a nice fat raise and an equally attractive bonus, but the reality is that the economy is kind of in the toilet right now so I am happy just to have such a great job...oh, but I still want a raise anyway.

Thursday, January 8, 2009

How to Break In to the Industry

So, you want to become a CRA?

Sure you're bright, astute, willing to learn, and capable, but getting your foot in the door in this industry can be a real uphill challenge. I know you will find your path, but I can offer some tips and advice to hopefully help you. If you are interested, you can click here to read the story of how I broke in to the industry.

By my analysis, these are the items (in no particular order) that matter most when you are considering a new career as a CRA:

Transferable Experience – A medical background or degree in Life Sciences will be of great use to you. Working in the industry (even if it was in the lab, manufacturing, etc.) is relevant so don’t discount it. Think of the skills you use everyday in your other job(s) and how they could bring value to you as a CRA. I switched from Data Management and the Commercial side of pharmaceuticals and many hiring managers were dismissive of that experience. I stood up for myself every time and explained that the skills of data analysis and the ability to finesse the strong personalities of a pharmaceutical salesforce are incredibly relevant and transferable to the CRA role.

Living near a major city will make
you a more attractive candidate.  There
are more jobs and proximity to a large
airport with many flight options makes
travel that much easier.
Geography - One of the most attractive things about the CRA career is that you can work anywhere so long as you are near an airport. Well actually, that is one of the most attractive things for experienced CRAs who want to work from home or regionally. If you don’t have 3-5 years experience yet, you’ll have a much harder time landing a gig if you live in the boondocks. Major hotbeds for CRA jobs are cities where you find lots of pharmaceutical/device companies, CROs, and strong universities. These hotbeds in the US include New York, Boston, New Jersey, Philadelphia, North Carolina, Seattle, San Francisco, San Diego (but not so much here anymore), and I suppose there is a mid-west hotbed but I haven’t spent as much time in that part of the country to advise. My point is that entry-level positions can be most easily had in larger organizations and you find those biggie companies in the hotbed communities so geography matters.

Network - Join a professional organization like ACRP, DIA, or similar and attend their regional/local events. Read their publications and scour their knowledge bases. By attending the meetings and participating in the forums you will make valuable contacts. Follow-up with the contacts and do some informational interviewing (no, not asking for a job! asking what their job is like and what their company is like, why is their job fun? interesting? frustrating? demanding?). You may be able to volunteer on small projects or tap into short term contract assignments through your network to build experience. Someone in your network may pass along old training materials or valuable tips to you so don’t discount the network and always keep it warm by following up with your contacts on a regular basis (no, don’t stalk or harass them, a quick note or call once every other quarter should be adequate or just connect with them on a networking site like

Doing your homework - Read the internet and blogs like mine, know the CFR and GCP. Read books about clinical research, read the sector news, know what’s happening in drug development with big companies in your area and use the information to connect with people at interviews or at networking events (I have linked to some recommended books/articles in the right hand column of my blog). My browser homepage has RSS feeds that scour Yahoo!News for recent articles that reference companies I am following (CROs, pharmaceuticals, biotechs, and other health industry players).

Willingness to learn - I’m sure this is self-explanatory. As stated above, demonstrate your willingness to learn by volunteering at your professional organization, taking classes at an extension college or night school, and asking people for their old CRA training materials or industry journals.

Personality/Communication Skills - As you’ve gathered, this job requires a good degree of high energy and commitment. It will serve you well to be meticulous, focused, and assertive. You must be able to negotiate and communicate effectively and concisely because you have to constantly work with sponsors, sites, vendors, and peers to reconcile everyone’s opposing agendas.

Patience - Some companies are just going to be more able/willing to train than others; especially now when the American economy is suffering. Consider signing on as a contractor. Prove yourself in 3 months and maybe they will extend you 6 more. Maybe they would offer to bring you in-house as a member of their permanent staff. The great news about a contract is that you gain experience, walk away no strings attached, and when you start over somewhere else you’ll likely be compensated higher for that experience.

I believe it is easier to get an in-house CRA job than a traveling monitoring position as your first gig (traveling monitors at CROs are offered training programs that last several weeks to several months and this is a huge investment so it is easier to get these positions if you have had other relevant positions in the industry…or a great referral or networking contact). Consider building your credentials and industry experience as a CRA Assistant or even a Project Assistant (mostly making copies and taking meeting minutes - but a great way to learn the regulations and the industry). Don’t forget that there are different types of in-house positions that might appeal more to you than CRA. If you choose to specialize, you could become a legal or finance assistant (dealing with contracts and payments between study sites and sponsors) or a regulatory document specialist (I would hate this because it is mostly filing and paper-pushing but it is a great fit for the right personality). I got my start as a Data Manager so that is another avenue but making the switch from CDM to CRA is quite tricky. If you aren’t finding anything in Industry, you could even try to get a job at an MD office or study center assisting with subject processing and other study related tasks.

Good luck as you pursue the role of CRA. Please comment if I have overlooked other important factors or if you have questions.

Monday, January 5, 2009

How I got here

Today I am reflecting on how I came to be a CRA and thought I would share the specifics of how I ended up where I am today.

I did an internship for the marketing department at a large pharmaceutical company all through college and then went to England my final semester to finish school and earn my degree in Business Management (coursework in Marketing and Computer Science). When I returned to the states I worked full time as a Clinical Project Assistant contractor at a large CRO for a few months doing patient recruitment, supporting the PIs when they had protocol or IVRS questions, managing study materials (CRFs, mailings, etc.), and performing Quality of Life (QOL) assessments to enrolled patients via the telephone. I wanted a permanent position so I joined a large specialty biotech working in commercial field sales support. After a few years, I was up for a promotion and relocation to another state, however, my boyfriend had an offer to move to San Francisco with his employer so I left on good terms and relocated with him.

I had been taking pre-requisites for nursing school before we relocated but eventually decided that stepping out of the workforce for up to 2 years would cost me more than the gains in salary than the RN credentials would give me so I abondoned my plans to get the RN BSN. In the Bay Area, I worked at a small data management firm and then a company that created EDC software. In these position I built databases, developed/programmed edit checks, and validated databases for various studies in multiple therapeutic areas such as oncology, device, cardiac, etc. From there I moved on to an in-house Data Management position and provided support for biostats and managed external vendors. I made connections with the clinical group and networked my way into an open in-house CRA position.

In order to prove my commitment to the CRA career trek, I took CRA training courses at the extension college for the rest of that year. There is no substitute for experience so I had to be prepared to take a pay cut. I decided to approach it like going back to college. I couldn't exactly take out a student loan, so I just managed the best I could and made sacrifices like lowering my contributions to my 401K, living a little more meager, skipping Starbucks, etc. I read a lot of Suze Orman, complained to my girlfriends, and in time I had the experience I needed to merit pay increases and an eventual salary adjustment. I had to ask for all of these things, but fortunately for me, my bosses have been nothing if not overall fair and reasonable.

I travelled both domestically and internationally for that job and I loved it but my primary responsibilities were trial fiscal management, protocol development, and overseeing the contract monitors. I was so eager to be out monitoring more on my own that I moved on to a large CRO and now I travel all the time and love it! Ultimately I want to be an Independent Consultant and eventually provide more Sr. level CRA services. I know it would be a great gig for me because I am experienced in this industry, an excellent communicator, willing and able to travel, tech savvy, and self-motivated but that is still several years down the road.

I hope you find my story helpful if you are trying to get your foot in the door as a CRA. It took me several years of networking and determination but I am thrilled to pieces with my job and wouldn't trade it for anything.