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Friday, February 8, 2008

What to Expect at a CRA Interview

I’m posting to let you know what kinds of questions you might expect to be asked during a CRA interview. Practice these in the shower, in front of the mirror, or with a friend so you are prepared!


Typical Questions
Here are general questions that you will likely be asked with tips for answering shown in italics:
  • Tell me about yourself? Keep it short and hand them a copy of your resume to look at while you give the penny-tour of your background and experience. Showcase yourself, “I live in San Francisco and I have 5+ years experience in this industry. I have been working as a CRA for over 18 months. I have had the opportunity to work in Phase I, II, and III trials for the following indications… I attended courses for CRA training through a local university and I am an active ACRP member.” Be prepared to explain why you are currently job seeking and any gaps in your employment history or a trail of many past job over a short period of time.
  • What are your salary requirements? I’ve had success with this script, “I will consider the entire package including employer flexibility, 401K, a competitive benefit package, etc. However, my minimum salary requirement is $$$$. I would be pleased by a compensation package that includes benefits and incentive compensation to increase the value. From my research, it appears that similar positions in this industry are paying between $$$$ to $$$$.” Then be quiet!!!
  • What percentage/amount of time are you willing to travel? Be honest. Travel is difficult and it is not in yours or the employer’s best interest for you to misrepresent yourself when this question is asked.
So here are the more role-specific questions:
  • Have you had GCP training or formal CRA training through an employer or accredited course?
  • Do you have experience with the following?
    o Regulatory document review
    o Selecting and recruiting qualified and interested investigators
    o Performing source document verification
    o Utilizing EDC, electronic diaries, or IVRS systems
    o Database close
    o Development of protocols or ICF?
  • Do you have experience with the following therapeutic areas: Cardiovascular, CNS, Oncology, Diabetes, HIV, etc.? If you are interviewing with a CRO this is especially important because they will need to market you internally and to clients. There is no sense in lying here because there is no substitute for experience. Try to highlight experiences you have from other jobs that better prepare you for a monitoring role. For example: “Although my oncology experience at this point has been limited to clinical database and CRF design, that experience has afforded me the opportunity to read through no fewer than 10 to 15 different oncology protocols from a variety of sponsors and assist (at least on the data end) in these sorts of trials. I have had the opportunity to develop some very fundamental and transferable skills in XYZ indication this past year related to study start-up, maintenance, building/maintaining relationships with study sites, trial fiscal management, and facilitating cross-functional trial specific working teams to track and deliver important study milestones on time/budget.”
  • What is the greatest number of [protocols, sites, patients] that you have been responsible for at any one time?
  • Which phases have you worked in?
  • How many [pre-study qualification visits, site initiation visits, site monitoring visits, site close-out visits] have you conducted in your career?
Undoubtedly, the last question you will be asked is, "Do you have any questions for me or about our company?" And the answer is, Yes, you do! I know you will be nervous, but ask good questions and listen to the answers to the questions and try to get feedback during the interview so you know how you are doing.  You may have been misunderstood during the interview or missed an opportunity to really sell yourself.  Asking great questions will give you one last chance to show your best or address any concerns the interviewer has before you part or even in a follow-up letter or email.  Here are some generic ones, but you have to ask something:
  • Describe the three top challenges that I'll face in this job?
  • What are the key metrics for measuring success in this position?
  • If I were offered the opportunity to work with your organization, what would you like me to accomplish in my first 90 days?
  • How would you describe the qualities of the most successful people at your company?
  • How closely do my qualifications match the requirements for the open position?
Interview Styles
At this point, I want to mention that there are various interview styles. Being familiar with how (and why) questions might be asked will only help make you more prepared when it is time to come up with the answers. I am going to discuss a few interview styles below. The person conducting the interview may stick to just one style or have a mix of several – this is especially true when you are in a panel interview. Then it feels like you are in a firing range but just stay calm and try to engage the panel so you aren’t doing all the talking. After all, this is your opportunity to interview them, too, right? Anyway, here are a few interview styles you might encounter:


Behavioral – Everyone knows that past behavior is a very good indicator of future performance. This interview style will require you to answer in a manner that shows you are creative and quick on your feet. Sometimes the right answer is not as important as the delivery. Before you answer think hard about why they are asking this particular question and try to cite examples of past behaviors that are relevant to the job you are applying for and explain at the end how the skills and experience you are describing would be transferable in your new role. If they ask you about a past mistake or you describe something you did but would now do differently, say so and explain why. Nobody is perfect so showing that you learn from past experiences can only help you in the interview.
  • Tell me about a time when you showed your ability to [adapt to a new situation, solve a problem, etc.].
  • Tell me about a time when you demonstrated [initiative, integrity, excellent communication, etc.].
Situational/Scenario – If you have no idea what the right answer is, you can try stalling, asking the interviewer for help, or just qualifying your response. For example, “Honestly, I am thinking of a few possible answers for the question. On the one hand, I feel like this might be the right response, but on the other hand, I can see a scenario where this might be the right approach. Which are you looking for?” or “Well, I must admit that I haven’t ever been faced with this particular situation, but I imagine I would handle it as follows….” Here are some examples of situational questions:
  • You’re at a site and discover an unreported SAE, what would you do?
  • You are performing a routine monitoring visit and discover that the site has enrolled a subject but forgot or improperly consented them, how would you handle this situation?
Assertive – I personally find this style offensive. Any employer that utilizes these tactics is likely not one that I am very interested in working for. After all, if they are a jerk in the interview, what is it going to be like on a daily basis or when it is time to sign your expense reports, or partner to work on your performance goals, etc. In any case, an assertive interviewer will treat you really nastily or act very cold/aloof to see if you will get nervous or flustered. I find brevity is key in these types of interviews and if there are long periods of silence, just sit calmly and pretend like you are unaffected. Be careful not to be too defensive – it is usually a trap to see if you can keep your cool under pressure. They might say something catty like:
  • It sounds like you don’t have a lot of experience with [insert something rude here], what makes you think you can do this job?
  • I have a lot of other more qualified candidates, why should I hire you?
Structured – This interview is basically just like a test and you need to pass to make it to the next round. It is a typical style for CROs (where many different people perform new candidate interviews but then need to assess all applicants against the same standards) or for first-round interviewers. Essentially, the interviewer is looking for a specific answer, and once you say the magic word or list the 3 bullets they are looking for, they will move on to the next question. It is fine to ask how you are doing if you are feeling nervous along the way – they will probably find it endearing rather than count that against you (they probably suffered through the same type of interview when they were hired).
  • What are the critical components of an ICF document? Know your regulations and GCP guidelines – All of them – this one is CFR 21 Part 50.
  • What are the activities that take place during an [initiation visit, close out visit, etc.]?
Conclusion
Every person you interact with may be
asked to provide input on your interview
performance.  Remember to always respect
"gate-keepers" like reception/administrative
staff and the HR person who arranged
the interview.
Here are a few other random tidbits of general interview advice:
  • Show up on time, be well-dressed/groomed, and be nice to the receptionist.
  • Fill out the employment application in advance. When you ask for this you are demonstrating your enthusiasm for the position and you are showing how organized and methodical you are when approaching new situations. If there is no application to be completed, at least bring your government issued ID and a list of references and old employers in case this is needed.
  • Avoid sounding cocky, smug, or coming off as entitled.
  • Assess how the interview is going by using any of these targeted questions after you provide an answer: “Did I give you enough detail?”, “Was I clear on that?”, or “Would you like me to elaborate?”
  • Never ever ever lie about your experience! Our industry is a small one and your reputation will precede you. It is a huge risk so just avoid it. Besides, as CRAs our primary objective is to ensure the safety of subjects exposed to Investigational Product. As an extreme example, if you lack the experience to do something and say that you actually can, you may be given a position that you are not qualified for and as a consequence, subject safety could be jeopardized.
  • Never say anything nasty about a previous co-worker or employer – it only makes you look bad.
  • Watch for and avoid illegal questions – It is absolutely inappropriate (and in some cases against the employment laws) for the interviewer to ask you questions about your age, race, religion, marital status, and whether or not you have kids. If you choose to volunteer this information in the course of an interview, fine. However, if you are queried about any of the items above just say politely, “I’m sorry, I don’t feel comfortable with that question but would be happy to address any others you have.” or re-direct the questioning in some other tactful way.
  • At the end of the interview thank them for their time, ask what the next steps are in the process, and ask for the job! I know it sounds silly, but 90% of applicants won’t ask for the job. You don’t need to be shy. You researched this company for weeks, you got all dressed up and took an entire day (or several) to come in and interview. You don’t need to dance around why you are there, “When can I start?”
Now you know what kinds of interview questions to expect but this is really putting the cart before the horse because we haven’t even scratched the surface of how to execute a sound job search. I will be posting in the future with more information that will make you better prepared for your new CRA role including: ‘Choosing the Right Company as Your New Employer’; ‘Networking’; ‘Doing Your Homework Before an Interview’; ‘Following up After the Interview’; and ‘Tips For Excelling in your First 90 Days of Employment’. Let me know if there are other topics that are of interest and I will be sure to address them in other future posts.



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Saturday, February 2, 2008

Home from the Investigator's Meeting

I've been assigned another study and attended a kickoff and Investigator Meeting on the East Coast last week. As I mentioned in my last post, an Investigator's Meeting is basically a chance to get all the doctors and staff together at one venue with the sponsor (usually a fancy hotel or somewhere fun) so that all the details of the study protocol can be reviewed and everyone's questions get answered. Also, because a lot of money is spent at these meetings to woo, wine, and dine the Principal Investigators (PIs), the meeting has the bonus effect of getting everyone psyched up and excited/competitive about enrolling in the study.

For my new study (it is a high cholesterol drug therapy study) I will have 11 sites each of which needs to be visited at least every 4 weeks depending on enrollment. There are 60 PIs total and 4 other CRAs but I am the only one on the West Coast. I am lucky that 7 of my sites are located near one another in LA so I can combine my visits into longer trips and not have to fly so often. I also have 2 sites in Phoenix, a site in Seattle, and a site 1.5 hrs drive East of my house. In any case, this is a heavy site load but luckily it is a straightforward study and the PIs seem to be both experienced and motivated.

An electronic patient diary looks just
like a little PDA and the patient gets
an alarm to remind them it is time
to take their medicine or fill out a
little outcomes summary. This data
gets sent in via the telephone or
loaded into a computer and is used
in the study analysis.
The trial leverages some cool technology such as an electronic data capture system (so CRFs go into the computer in an EDC system rather than on triplicate forms) and the patients all get electronic diaries (little palm pilot devices) so they can capture adverse events and be reminded when it is time to take their medicine, plus the medicine (Investigational Product - IP) comes in blister packs one week at a time, so drug accountability should be a cinch thanks to this clever packaging. This is a proof of concept study so there are 6 different study arms (some patients get placebo, some get the real drug, some get a mix of both...) and only 275 subjects will be enrolled. The subjects take their meds for around 7 weeks. Recruitment is anticipated to end in mid-April so it is a really short enrollment period. The Inclusion exclusion criteria are very tight so a high number of screen failures are expected (up to 800). Luckily, screen failures will not get their own casebooks but just be captured in the Integrated Voice Response System (IVRS) web portal.

In my next post I will tell you more about how to prepare for a CRA interview and what types of questions you can expect to be asked. Then I will post about Routine Monitoring Visits, as promised. Let me know if there are other topics that are of interest to you by emailing me or leaving me a comment here and I will be sure to address them in future posts.

Monday, January 7, 2008

Pre-Study Visits and Site Initiation Visits

Depending on the company you work for and the Standard Operating Procedures (SOPs), you may be required to complete an in-person Pre-Study Visit (PSV) before an investigator is initiated to join a clinical trial. In some cases, you may even be able to perform this via telephone, web-conference, or it might be waived altogether (say, for example, an investigator your firm has collaborated with in the past 18 mos or so).

The objectives of a pre-study visit are to review the adequacy of the site, the training and experience of the study staff, the access to the right patient population, and the site's interest in the study. If the site isn't motivated or if they are already participating in studies that would compete for the patient pool, they may not be a good recruiter. It is expensive to start up a site, monitor them, and supply them with all the study materials and training. Ideally, you would only open sites that would perform well but in reality, there are always 'dud' sites in every study (Read my related post on Selecting Qualified Investigators). This is typically a 2-4 hour visit. After your visit, you will likely need to complete a report template or assessment and send a follow-up letter to thank the site for hosting you and inform them whether or not they have been chosen to participate in the study.

At an Investigator Meeting there may be
presentations and break out sessions
to answer questions and train study
staff with the skills required to properly
execute the protocol.
The initiation of a site can sometimes occur at an Investigator Meeting (IM) where all the potential investigators are brought together in (a typically quite fancy) hotel or other conference arena to receive group training on the new study. More often, however, this will actually take place - on-site. This is usually a 4-8 hour visit and you may be accompanied by a Project Leader, Medical Monitor, or even Data Management personnel just depending on the desire of the sponsor. Before your visit, you will coordinate a convenient time for the study site and confirm your visit with a letter informing them when you will arrive and what the objectives of the visit will be. It is important to physically be at the site so, as a monitor, you can visit the labs, pharmacies, and other areas where the research will be conducted to ensure they are adequate. For example, both labs and pharmacies should have restricted access and the site should know where it will store the Investigational Medicine/Product (IP) and this location should be locked. If the site will be storing blood or tissue samples, you will inspect their freezers and ensure that they maintain adequate temperature logs and have standardized sample handling protocols and training.

During your initiation visit you will probably spend a great deal of time training or reviewing the study protocol design and answering questions from the site personnel. You will also want the Principal Investigator (PI) to be available for specific parts of your presentation. Specifically, you will need to discuss the Investigator's Responsibilities as related to the regulations to ensure there is agreement and understanding (The investigator may choose to delegate some of his/her responsibilities but ultimately, they will be responsible for all actions and conduct of the study. Specific study related activities can only be delegated to those who posses adequate training and experience -- a secretary cannot perform a Physical Exam, etc.); You will explain publication policies and documentation responsibilities; You will inform the PI that you will need timely access to subject's records and the acceptable time frame for completing patient data case report forms (CRFs) and answering queries regarding the data). Document everything that is discussed so you can add it to your report and if there are any questions that are unresolved at the end of your visit, you can include resolution for those in your follow-up letter after the visit.

Email me if you have more specific questions. Now that our study is underway, next time I will discuss how and why we complete routine monitoring visits throughout the study conduct period.



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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 maps.google.com. 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.

Conclusion:
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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