All content copyright, Creative Commons Attribution-Noncommercial-Share Alike 3.0
Unported, with the attribution: "The Lead CRA Blog", and a link to the post.

Saturday, February 16, 2008

Tips for Frequent Travelers

So I have already written to you about travel safety, and now I am going to write about some travel perks; mainly hotel points and airline miles. It is to your benefit when traveling for business to accrue some rewards for yourself. First you will want to obtain and read a copy of your company's travel policy so you know where they can flex and where you will need to flex. For example, my company requires me to book through their travel agent and we have preferred hotels and a preferred rental car company. I must pay for everything with my corporate Amex and then be reimbursed (so other loyalty Credit Cards are not an option) but I can (and do) add Membership Rewards to my Amex account for $75 a year and collect membership rewards points for every dollar of my employer's money I spend on travel to and from sites.

I spend a lot of time on airplanes and
collecting reward miles is a real perk
that I can use to obtain discounted or free
 leisure travel.
In regards to airfares, it is wide open so I can research and communicate to the travel agent which fares I want provided they are within the travel policy guidelines. In this way, I can maximize my reward points and choose to focus my reward accruing efforts on a preferred airline/chain so I can rack up miles/status/points for leisure travel. Be careful of diversifying too much or you will only achieve a low level of status/rewards in many programs whereas it is typically better to have a lot of status/rewards in just a few programs. This is less flexible but in general, you will see greater returns when you focus your efforts.

I was first going to attempt to download all the tidbits I have learned over the years but then decided a list of my favorite web links would be much more effective.

Find the Lowest Airfares

  • ita software - Click on the graphic in the lower left called 'Search Fares using QPX'. Be exact with your entry as this system can't really 'guess' at what you want. When your results come up use the third toggle button at the top to 'choose flights (graphical)' Now you can sort and stack and filter or just choose one segment at a time. I love this site! The only airline I have found not listed so far is SW so I just check them separately.
  • - Another price aggregator as above.
  • - Will the fare be cheaper if you wait until next week to book it? This site tells you!
  • - Tag a fare and book it once it is cheaper. If the fare does drop after you already booked (assuming you booked directly through the sirline website) you might be entitled to a refund or future credit thanks to the low fare guarantee).
  • Many airlines will give you bonus miles for booking through their site. I can't do this because we are required to use the agency but this is especially powerful when you own and book with their co-branded credit cards. Something to look into...

Booking Hotels

  • Again, pick one or two chains and accrue status so you get upgraded rooms and executive lounge access, free breakfast, bonuses, etc. Plus, once you are at the higher tiers you typically accrue points faster. This chart is helpful for comparing the different loyalty programs - thanks Starwood Preferred Guest program!
  • One more tip here, once you get high level status in one program call competing programs and ask them to 'status match' or to allow you to 'challenge' the high tiers of their loyalty programs. These promotions are usually offered in the first half of the year. Airlines will status match, too -- never hurts to ask, anyway!


  • - Make informed decisions when choosing your seat - make sure your seat fully reclines and that it doesn't have a blocked view of the TV or limited space.
  • - How many seats are left in each class of service on a plane. Helpful when you are hoping for operational or status based upgrades to a higher class cabin or if you are looking to get bumped (sometimes you can plan to miss a flight because you will be compensated with a free roundtrip US ticket or a discount voucher for future travel).
  • - An ever-changing Wiki that has aggregated information about traveling and loyalty programs. Companion website to flyertalk, see below.
  • - This is an online forum with lots of frequent travelers who share their tips. I subscribe to posts and threads and I get these emailed to me weekly. I download my email to a local client so I can browse through them in digest format while on my frequent flights. I have learned so much here and love this free site.

Tools for Tracking Points and Miles

  • I prefer a web-based program so I can recommend the following: (this site is free to try for 30 days and then $14.95 annually. It has rewards summaries but also lets you know which accounts are about to expire, and my favorite part is the 'Elite status summary' which tells you what you need to earn to get to the next Elite level in any given program.)
  • (this site is free and will also manage your personal finances and help you set budget goals or you can just add your reward programs and have it manage those exclusively. Of note, your bank might already subscribe to this service for you as some major financial institutions like Bank of America, Fidelity, and Wachovia do... Check here)

Shoot me an email or leave me a comment if something important is missing from this post or you have more questions about this topic that I can answer. I would also love to hear your tips and success stories so feel free to leave those comments as well!
Read more about What to Pack in this post.

Tuesday, February 12, 2008

Clinical Fraud Hearing Held Today

I received an email from my old boss today alerting me to an interesting webinar. I am posting it for other people's benefit. She states "The webcast below is a hearing to explore fraud at a clinical site for a study conducted by Sanofi-Aventis. The hearing took place this morning. Interestingly, the CRO and the CRA who monitored the site are among the witnesses..."

from the webinar site:
"Ketek Clinical Study Fraud: What Did Aventis Know?
The House Energy and Commerce committee’s subcommittee on oversight and investigations will hold a hearing at 11 a.m. EST to explore what Sanofi-Aventis knew about the problems with clinical trials for its Ketek antibiotic. Last February, the FDA withdrew approval for two of three uses for the drug, and issued a Black Box warning for use in treating community-acquired pneumonia, which was issued in the wake of numerous Ketek patients suffering 93 adverse events, including 12 deaths.

Among the witnesses will be Chuck Grassley, the US Senator from Iowa, and Ann Marie Cisneros served as a clinical research associate for PPDI, a contract research organization that conducts clinical trials on behalf of drug sponsors. Last February, Cisneros appeared at a hearing held by the same committee focusing on the FDA’s failure to ensure safe prescription drugs. Cisneros testified that Aventis knew of fraudulent clinical trial data involving Ketek, but that the company chose to ignore it."

Go here to watch an archived webcast

Feel free to comment on this post or shoot me an email if you have any thoughts or additional questions.

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.]?
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.

You may also like...from The Lead CRA:

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.