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Tuesday, November 20, 2007

Staying Flexible and Creating my CV

Working at home isn't all bad but I
have to stay focused and shoo off
distractions like my little yorkie, George.
I have been kicked back at home in my bunny slippers pouring through the SOPs and online training courses for my new CRA gig. As of orientation, I was assigned to one study but now I have been picked up for 2 different ones (luckily in lieu of the first rather than in addition!). One of the first tasks every new CRA at a CRO must complete is entering your Curriculum Vitae (CV) into the corporate database. CV is fancy biotech jargon for résumé (Wikipedia tells me that CV is Latin meaning "course of life" and résumé is French meaning "summary"). Basically, you want to chronicle all of your past relevant work experience but more importantly, you must complete an inventory of all of your relevant skills and therapeutic experience. I had to indicate which Phases of clinical trials I have experience in, what types of studies I have worked on, and quantify everything...3 months? 6 months? 1 year? The other fun part of the CV was the summary section where you write a little paragraph about yourself in the third person.

Nadia BoBadia, BS is a CRA II responsible for monitoring clinical studies with various indications. Before joining the company, Ms. BoBadia was employed as an in-house CRA I at a specialty cardiovascular biotech company, where she managed site budgets/negotiation,forecasts/accruals, and processing/disputing invoices, along with monitoring 3 Phase I cardiovascular and pulmonary trials. She traveled internationally to support FDA audit inspection preparation visits and NDA triggered activities for 2 large Phase III studies. For two years Ms. BoBadia was employed at a CRO and an Electronic Data Capture (EDC) company performing data management functions including designing CRFs and clinical study databases for a variety of therapeutic areas. Prior to that she was employed at one of the top 3 pharmaceutical companies and a large biotech performing commercial product and field sales personnel support for pulmonary and CNS indications. She has additional experience as a project assistant on a Phase III Ophthalmology study. She joined the company in 2007 as a CRA II.

So this electronic CV is what the sponsors (pharmaceutical and biotech companies that have contracted with my service company to run part or all of their studies) use to decide whether or not you are appropriately trained to work on their studies. So even though I have a job, it is like I am constantly interviewing in order to be able to do my job (get billable hours/activities). I know in time my skills inventory will be so impressive that sponsors will be delighted to pick me up for their studies so that is definitely satisfying.

Half of the folks from my training class are already out traveling and monitoring but I have to finish my study specific training (reading the protocol, monitoring plan, sponsor SOPs, etc.) and receive my site assignments. Right now I am projected to start traveling the week of Dec 2nd so I am just enjoying the downtime while it lasts. I have been enrolling in benefits, setting up my home office, playing with my new printer/fax/scanner, ordering office supplies, and generally keeping myself busy.

Thursday, November 8, 2007

New Hire Orientation

I have been at new hire orientation all week. We started at 8:30a on Monday with HR. They reviewed new employee stuff including company history, benefits, and general company information. I was greeted at lunch by two long-time employees who took me out for a nice meal and told me more about the company culture and their studies. Most of the CRAs at training already knew what their assignments would be but I didn't even know who my manager was at this point.

After lunch, IT came in to deliver rollerbags and laptops. My laptop is more like a workstation (but it is tiny, light, and so cute!) because I have no administrator access and can't even change the system time or download a thing. Sites like YouTube are blocked but luckily Blogger works! Unfortunately we use Lotus Notes so that will take some getting used to. In my previous CRA position I was addicted to my MS Outlook calendar and contact functions. I have a PDA phone by Motorola so I would sync this constantly and it will be hard to go without. Lotus is 21 CFR Part 11 compliant and my CRO has chosen it because of its database capabilities. Every study gets a repository where essential trials documents and forms are stored and this is all shared through Lotus. This is better than a share drive because the repository can be 'replicated' which is a fancy term for saying I can view it even if I can't get on the VPN. For homework I had to read the employee manual.

I talked a few of the CRAs into joining me for dinner so it was a fun and relaxing evening. The next morning we reported for CRA II training. There were 6 of us in the class and we are all Regional associates (4 from the East Coast and a gal from Phoenix). CRA training lasted only about 3 hours and was just a quick review of ICH/GCP and a 'how-to' for source document review. After lunch we learned how to track our time. The system we use is not terribly complicated and I finally found out what study I would be working on and since it is only one at this point, reporting my time won't be so difficult. As CRAs, we are expected to be 85% billable. That means I need to be traveling or doing client work most of the time. I have to 'bill' these items to the sponsor by accurately completing my timesheet. This is easier said than done; I have been telling people it requires a bachelor’s degree because each 15 minute increment has to be coded to the specific task you are completing so it can get complicated. For homework we had to mock up a sample timesheet. Luckily completing your timesheet is billable because it takes a while!

All the new CRAs are asked to take part in a bull-ride
challenge.  If you can last 30 seconds you advance
to the next day of training.  Just kidding!
The third and final day of training was a hands on demo of how to complete an expense report. Again, this is no easy task. It is made easier by the fact that I was issued a Corporate Amex. I will put all charges on my Amex (except where it isn't accepted) and keep my hotels under $150/day and meals around $50/day unless I have written manager approval to go over (which will be required depending on what cities my sites are in). There is no preferred airline but I will be using National car rental and usually Hilton hotels as they are the preferred vendors. A large CRO can have 'preferred vendors' because they require traveling employees to use Amex. In this way, they can run queries to see how many nights employees stay in hotels and things to negotiate special preferred rates. I will have $30/mth for a cell phone stipend, my broadband and phone line will be reimbursable including installation. I have been given a $1600 stipend to furnish my home office. Lucky for us, charges to the Amex pre-populate into the expense report so that helps. Corporate pays the card directly as long as I submit the expense report within 14 days of the trip. Airfare will always be non-refundable so I can submit the expense report the moment it hits the Amex and do not need to wait for the trip to actually occur first.

It was a busy 3 days but a lot of fun, too and I may never again venture to corporate headquarters so it was a nice opportunity to get a glimpse of how the home office runs. I will hopefully have project specific training soon and meet my line manager (at least over the phone anyway). Now I am busy reading SOPs and doing on-line training for the next few days.