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Thursday, December 27, 2007

Introduction to Monitoring

I've been out on the road for the past few weeks assisting some other monitors to review patient's medical records and the data that has been collected for the clinical trial. It occurs to me, that it would be beneficial at this point to further describe to you the roles and expectations of a Clinical Research Associate (CRA).

In a pharmaceutical/biotech company, teams of scientists are working to discover new molecules, compounds, and foundations for new drugs. In addition, these same scientists sometimes work to re-formulate current drugs or apply them for new diseases and indications (all of this work is done in animal models before the human clinical trials can begin). It is at this point that monitors such as myself come into play. Once an experiment that involves humans is designed, monitors help the company choose qualified and interested physicians to carry out the study. These 'investigators' are reimbursed for their efforts to conduct the trial and a CRA may also help negotiate the budget and/or contract between the parties involved.

A CRA job is a traveling job. Sometimes we go to glamorous places but more often than not we are monitoring in hard to reach or otherwise obscure locations. 
Objectives when we visit the investigative site (Doctor office, hospital, research center, etc.) include: 1) perform pre-study tasks during a Pre-Study Visit (PSV), 2) kick-off the study with a Site Initiation Visit (SIV), 3) routinely check back with the site regarding subject enrollment, trial conduct, and data collection during one (or typically many!) Interim Site Monitoring Visits (MV), and finally 4) shut down the site after their participation has ended during a Close Out Visit (COV). Before and after each visit, there are a variety of tasks and communications that need to occur in regards to preparing for, scheduling, confirming, and then following up on items from previous visits. Read some of my other blog posts to learn more about Site Initiation Visits, Routine Monitoring Visits, and Close-Out Visits.

Also, between visits, a CRA needs to regularly contact the sites and perform site management activities such as answering questions regarding the study design, encouraging enrollment, sharing tips from other sites, and distributing study drug (Investigational Product, IP), and managing site supplies inventory levels (often you are assigned up to 10 different sites to manage but this really can vary depending on geography, how many patients/doctor sites are participating, how many monitors are on the study, how complex the trial is, and a variety of other factors).

I'll explain more regarding the key tasks at each visit in later articles. There are many Federal and International regulations that apply to human research to ensure that the studies are valid, reliable, and above all, that the rights of the participating subjects are protected and we'll also get into those soon.

Sunday, December 2, 2007

Business Travel Safety

So I have just printed my boarding pass for my first monitoring trip with my new company. This reminds me that there are some great travel safety tips I would like to share with you all. Most of these are common sense or things I have picked up along the way from employers and other monitors. I know this is long but I hope you will find it helpful. Feel free to add comments if you can think of other important tips I may have left out.

Before you leave:
Use common sense when booking your flight and hotel. Monday flights get delayed so take an early one or just fly in Sunday night so there is no risk that you will be late to the study site. Friday flights are always oversold and late, try to return home on Thursdays when possible or stay over the weekend and explore a new city. Think about what time zone you are traveling to so that your flight times are practical and safe -- don’t arrive after dark if possible. Choose the right hotel – ask the site for suggestions or speak to other monitors you know. I like to read reviews on Trip Advisor. The most important criteria are not necessarily the rewards, pool/amenities, and mini-bar (but good room service is important). Instead, choose a property that has at least 3 floors (more on this later), ensure that there will be no outside entrance to your room (like at a motel), and stay in a safe neighborhood (even if this means a longer commute to the site).

OK, this is a business trip, not a fashion show. Keep your luggage light. This is not just a practical suggestion but an important safety tip. When you are struggling with several bags you are distracted and less aware of your surroundings. This can leave you vulnerable and make you a target for crime. Not to mention, the more pieces of luggage you have, the easier it is for something to become lost or stolen. Pack only what you need and leave extra room for all the important souvenirs/shopping you will bring back (or CRFs and regulatory study documents, whatever).

Print your itinerary and boarding pass before you go. I always forward a copy to my personal email (since I can access that from the internet and I like to sync it to my PDA) and to my boyfriend or a family member and my admin. Print an additional copy of your itinerary so you have a backup and put it in a different location in your luggage. When you are at the airport fumbling around for your itinerary, it might give criminals the impression that you are unorganized and an easy victim. You should know where your documents are at all times and your cash.

Just bring enough cash to pay for a light meal and a cab ride. I recommend splitting up your cash and credit cards (put some in your pocket, some in your purse, some in your briefcase, etc.) so if you are robbed you will not be in such a bad way. I think it is a good practice to leave behind copies of your Driver’s License and Credit/ATM Cards (including a copy of the back which has all the number you call if they are lost or stolen).
Don’t forget to bring your insurance cards (auto/health) and personal/business contact info (# for your boss, colleagues you will meet at the site, the site’s contact info!). In addition, I always program the hotel phone number and address into my GPS and cell/PDA. Don’t forget to program in the travel agent’s name and #, too (as well as after hours contact info). Print maps to the site and hotel so you will know where you are going. The rental car place will help you with this, you can contact AAA before your trip, or just use a website like Remember, even if you are taking a cab or black car, maps are still important. You will want to pay attention to the route the driver is taking and ask questions if necessary to avoid getting ripped off (running up the meter) or becoming diverted to an area that is unsafe or otherwise incorrect.

If you are in a public place keep
a low profile and try not to draw
attention to yourself. Casual
conversations with strangers can
be dangerous so ensure you are not
making yourself vulnerable by giving
away information about where you
are traveling, staying, or emphasizing
the fact that you are alone on the trip.
When you arrive/At your destination:
Now you are in a new and unfamiliar city and you are vulnerable for many reasons. You need to blend in (always know where you are going, pay attention to your surroundings, walk confidently, don’t flash wads of cash, and leave flashy/expensive items at home – like your jewelry and the Coach bag). Do not accept rides from strangers or unmarked cabs. When you are at the airport, restaurants/bars, or in the cab, do not give away personal information through conversation (always ensure that your name and address are covered on your luggage tags).

Cabbies always ask me if I am in town for business or pleasure. It is fine to be polite and carry on a conversation but keep it light and be smart. I’ll often answer, “business, but I am meeting my friends/husband later tonight.” If they ask what you do, use your discretion, but a safe answer is always, “Oh, work is boring, have you been driving your cab long?” If you can ask them a question about themselves or the city you are in, you can divert the conversation to more neutral topics. If the cabbie is nice, I always ask for their card and usually book them to return to the airport (plus if you find yourself lost while walking, you can call the cab and have them come pick you up). Your hotel can also help you find a safe transport back to the airport.

OK, so you rented a car. It is best to put your luggage in the trunk but make sure you keep the maps your cell phone and your GPS up front with you within easy reach. After you glance in the backseat (make sure nobody is hiding there), get in and lock the doors. Now figure out how the windows work and adjust the seat/mirrors/steering wheel before you leave the garage. Don’t keep your purse on the passenger seat. When you pull up to a stoplight or an intersection, someone could smash your window and reach in to grab this. I keep mine on the floorboard of the backseat (next to the person who is laying there – jk!). Always keep the gas tank at least half full – this is especially important in the winter or in rural areas where gas stations are not as frequent and cell phone coverage may not be as reliable (if you are driving in these areas a GPS is not always reliable so pay attention to road signs but at least the GPS can help you find a gas station where you can ask for directions).

Only park in well-lit places and remember where you parked so you can walk purposefully back to your car instead of wandering around aimlessly clicking the button and looking for flashing taillights (this is unsafe!). Every time you leave your car, lock the doors and check the handles to ensure it is locked. When you do return to your car check for flat tires; Criminals will let the air out of your tires so you have to stop later along the roadside and you will be vulnerable and open to their attack. Don’t click the button to unlock the car until you are right next to it. If there is a large van or someone standing near your car you can go back inside and wait for them to move on (or request an escort from security). You could also enter your vehicle from the passenger side (I appreciate that you will look silly but it is most important to be safe and you could always pretend that you wanted to quickly check for something in the glovebox). Most abductions happen during the day in public places like grocery stores or strip-mall parking lots so please pay attention even if it isn’t nighttime. Lock the doors as soon as you get in and buckle up. This is the most important, leave right away – don’t sit in your car and organize receipts or talk on the cell phone. This is just not safe.

Every hotel starts to look the
same eventually but never
let your guard down and
keep these safety tips in mind.
OK, finally you are checking in to your hotel. Request to stay between the third and eighth floor. The third floor is high enough that it is unlikely someone would break into your room from the outside, the eighth floor is the maximum within the range of fire rescue equipment. The room number should be written on the key envelope and handed to you. If it is spoken aloud, you must request another room. It is not safe for other people in the lobby to overhear your room #. Always ask for 2 keys (this makes it look like you are not alone plus you are less likely to get locked out if you always have one in your purse and one in your pocket). If you lose your keys don’t just ask for another copy, have them re-key the room (this is really easy for them with key cards). If it is an actual metal key, you need a new room – sorry, but you do! If the parking lot is not near your room, use the valet and if it is very late, it is always prudent to request assistance to your room.

Placing the “Do Not Distrub” sign on your door at all times will give the impression that you are in the room and possibly deter would-be thieves. If you go out, leave a light on for the same reason. You can call room service and inform them that you are doing this so they will still come and freshen up your room while you are away anyway. If someone knocks on your door, don’t open the door, ask who it is and call reception first to ensure that they are hotel staff. This tip might be overkill, but I just heard it and found it interesting…If you must let someone in your room, first turn on the shower and close the bathroom door. This gives the impression that you are not alone in the room. I suppose if they are there to fix the bathroom or something you will look like kind of a knob so decide if you are willing to risk it. ;)

Also, because I haven’t mentioned it anywhere else, be sure to avoid conflicts when you travel. Remember, you are trying to keep a low profile. This means your conflicts or the conflicts of others. If the airline or hotel piss you off (unbelievable, I know, but trust me it happens –ha!) just write down the details of what happened, time/date, names of people who were involved and make a complaint to corporate when you are back home. When you are involved in conflict you won’t be paying enough attention to your surroundings and this could be dangerous. If you see a disturbance or someone who needs help or is hurt, feel free to go find them help but do not help them yourself! I know this seems heartless, but you can make yourself a victim by getting involved.

Even if the city you are traveling to is a place that you frequent regularly, you always need to look AND be alert. Always follow your instincts. If you are in a place where you feel vulnerable or unsafe, leave. It is always better to look foolish than to become a victim. Use common sense and have a great trip! Add a comment or drop me an email if you have other great tips for business travel safety.

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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.

Tuesday, October 23, 2007

The Acceptance

I thought long and hard about which employment offer to choose but ultimately went with the larger company. Both companies would have been excellent but Company B just seems more adequately resourced to train me and offer the types of assignments that will be most beneficial at this point in my career (not to mention I talked them into a generous sign-on bonus to sweeten the deal).

I took a little vacation between jobs to visit with my family and ended up stranded in an airport on the East Coast for most of the day yesterday. I thought, "here I am, ready to begin a job that requires me to travel 80% of the time, am I going to regret this?" I took a shuttle bus home from the airport and the lady sitting next to me was also a CRA but she is an independent consultant and runs her own company. Right now she is working on an HIV study that has been going on for 5 years and the protocol has been amended 7 times. I don't know what study my new company might assign me to, but I hope it will be a quick one so I can learn the ropes and then move on to a new one. I have been guaranteed that I will not work on more than 2 protocols at a time but we'll see.

Orientation with my new company is on November 5th so I am working to finish up loose ends for my current employer and wrapping up some study monitoring at one of my sites in Tacoma, WA for the next couple of days.

Friday, October 12, 2007

The Offer(s)

I'm sitting in the airport heading home from my interview. I hope this will be the last interview for a while. Every 6 months I get the urge to switch jobs so I finally just chose a job that changes every 6 months, Clinical Research Associate (CRA). A CRA is responsible for traveling to MD offices, hospitals, and academic centers to ensure that clinical research for new drugs and devices is being completed in compliance with federal guidelines and International standards. I verify that subject's rights are being protected at all times and that the study is being carried out as designed across numerous or individual study sites. Clinical trials end and new ones begin all the time so the job definitely changes frequently.

I've been working in the industry for a few years and I know that CRAs at Clinical Research Organizations (CROs) get to work on a variety of different studies and the job is always different because you travel and work for all types of sponsors (pharmaceutical or biotech companies of all sizes) so I have spent the last few months identifying, researching, and applying to specifically these types of companies.

I now have two offers to consider. Company A pays $5K more than my current employer and company B is offering $10K more. The benefits are more or less matched but the corporate culture is different. Company B has around 4,000 employees and plans to double by 2010 as opposed to Company A that only has 400 employees (but also planning to double in size). Both positions are called regional positions which means I would set up a home office and work there .5-1 day each week. Every other day I would be flying or driving to different clinical trial sites or the corporate CRO site for training and development. Company A will need me to travel all over the US and probably Internationally (I still like flying). Company B will keep me close to home but this means I will have to drive more (I hate driving).

I have one week to decide so now the adventure begins!