ICON Warning Letter from the FDA

Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials.  My understanding is that the sponsor submitted the NDA, triggering routine inspections, and the CRO has now been asked to respond to a series of serious findings.  There were reportedly issues in regards to storage/dispensing of investigational product, protocol deviations, incomplete source documents, inadherence to the monitoring plan, and insufficiency in monitoring oversight.  It is a very detailed letter and appears to question whether 100% Source Data Verification was completed properly with a series of concrete examples of discrepancies.  As monitors, we need to comply with all regulations and stay abreast of these kinds of relevant FDA findings - hope you will find reading the warning letter as helpful as I have.  Here is the link again: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm193156.htm 

CRA Orientation and Training

I have been a Clinical Research Associate (CRA) for three years, but I recently accepted a new CRA position and thought it would be helpful for me to explain the on-boarding process. Whether you are working for a CRO, pharma/biotech, or as a consultant, there is always new hire orientation and training to complete. The CFR and ICH/GCP require drug companies to ensure that the monitors like me are qualified by training and experience. In order to demonstrate our compliance we must document that training. Our expertise is also documented in a signed copy of a CV.  Finally, we typically sign and date a copy of our company furnished Job Description to be saved in the training or employee files that serves as an acknowledgment that we understand what is expected of us in our role as a CRA.

I blogged a few years back about my experience in my last New Hire Orientation but I will elaborate today on what types of Standard Operating Procedures (SOPs) and training courses a CRA might reasonably expect to complete at any company. So the important thing to note is that you repeat some form of this training at any new company whether you have one year experience, five years experience, or twenty years experience.  In fact, even within a company you may find that you repeat these trainings annually or periodically - this protects you and the company because you have a documentation trail demonstrating your qualifications to monitor clinical trials.

Everyone signs off on the required training before they step foot into a clinical site. This protects you as well so be wary of any company that wants you to go out and monitor without proper training and qualification documentation in place - it really can be a risk for you.

Companies typically offer new CRAs administrative training, regulatory/procedural training, and project specific training.  Trainings can be administered via a traditional classroom setting, via webinar/teleconference, over the internet using recorded playback sessions, in person, or on-the-job.  Obviously there are pros and cons to the different formats (opportunity to clarify and ask questions, assess understanding, consistency of training delivery, level of interactivity and engagement, etc. but that is a bit off-topic for this post).  Irregardless of the format, at the end of each training some documentation is typically generated and signed (may even be signed electronically) to detail who led the training, who attended, the topics covered, and the date of the training.  You may be in training for a few days or even a few months.  The formality of a new CRA training program is very company specific but I am going to attempt to generalize the three categories of required training that I have experienced.  This is not exhaustive and certainly these may not all apply to you:

CRA Administrative Training
General: How to Order Office Supplies, Completing Timesheets, Expense Reports, Travel Policy

Information Technology (IT): Accessing the Computer, Intranet and Email Policy, Company Specific Websites or Applications, Using Microsoft Outlook/Lotus Notes, Setting up Voicemail and Email Signatures, Electronic Data Capture (EDC) System

Human Resources (HR): Company Overview, Employee Benefits, Performance Review and Employee Development System, Ethics and Compliance, Insider Training, Conflicts of Interest, Privacy Policy, Dispute Resolution, Harassment/Sensitivity Training, Ergonomics, Workplace Safety

Regulatory Procedural Training
Regulatory: 21 CFR 312 & 812; 21 CFR Parts 11, 50, 54 & 56; ICH/GCP; Good Documentation Practices; HIPAA/Confidentiality

SOPs: Informed Consent Process, Investigator Site Selection, Pre-Study Selection Visit (PSV), Site Initiation Visit (SIV), Routine/Interim Monitoring Visit (MV), Close Out Visit (COV), Source Document Verification, Record Keeping and Retention, Electronic Signatures, Fraud and Misconduct, Protocol Deviations, Audits, Inspections by Regulatory Authorities

Project Specific Training (may overlap SOP and general training)
Writing a Monitoring Report
Monitoring Plan
Trial Master File Maintenance
Completing Site Contact Records
Case Report Form (CRF) Completion Instructions
Integrated Voice Response System (IVRS)
Using Diaries, PDAs, or other Patient Reported Outcomes (PRO) Instruments
Protocol Training
IRB & Regulatory Submissions
Study Budget
Investigational Product Handling and Accountability
Randomization and Unblinding
Study Supply Management
Serious Adverse Event (SAE) Reporting

I hope this overview was helpful. I am happy to expand on any of this - just comment or email to let me know if you have follow-up questions.

US Clinical Researcher Competition

Have you been to a dream clinical research site? Do you know an excellent Study Coordinator that you would just love to work with again? Did you work on a project that was run so beautifully that all important milestones were delivered ahead of time and under budget? Perhaps you know a CRA who just excels at the role and has given you inspiration and valuable tips and training?

PharmaTimes, an industry specific news content service is hosting their first ever US Clinical Researcher Competition. There are 4 categories of awards including Study Coordinators, CRAs (less than 4 years experience and Senior CRAs), and Project Managers. Nominations and entries must be in by November 9, 2009 and winners will be announced in the spring of 2010. Here is a link to the contest website:

http://www.usclinicalresearcher.com/default.aspx

I've been monitoring for 3 years and there are a handful of truly memorable and outstanding professionals that I've had the opportunity to work with. I was delighted to hear of this new contest and I put in a couple of nominations as a nod to some of the fabulous folks I have come across. Here is the form to nominate in case you would like to do the same:

http://www.usclinicalresearcher.com/NominateColleague.aspx

Lead CRA Q&A: Am I getting a bad reference from a previous boss?

Anonymous said...

Hi, thank you for the advice you offer in your blog. Just a small question, I was referred for an interview at an international pharmaceutical company. I passed the first interview and was asked to have psychometric test which I was prepared for by a psychologist. They probably called my previous boss and after all that I received a negative response. This is the second time that I miss a good position after she was called. What do you think I should do? I have a lot to contribute to any firm, I just can't find them. thank you Y.S -September 3, 2009 6:46 AM

NadiaBoBadia responds...

Hi Y.S., and thanks for your question. I am sorry to hear that you were passed over for an opportunity that you were interested in. I am a very firm believer that things happen for a reason and I hope it will be of comfort to you to think that missing out on this particular job(s) leaves you available to find one that will be an even better fit and more rewarding experience. You would like to know whether you failed to land these positions because of your performance at the interview, due to results of an interview assessment, or because of a bad reference from a previous boss, or even a combination of any of those three factors.


You do have some control over the success of the interview. Please review my interview tips so you are always prepared - by knowing what to expect you are most likely to perform your best. To your second point, I have never been given a test or a psychologist assessment (to my knowledge) at an interview so I am not in the best position to give you advice. All I can say is that in the US we have laws that protect us from discrimination and you should always have your radar up for illegal interview questions and practices that may be used to exclude you. I am not speaking from a legal reference here, but I believe that if you agree to submit to the test you are consenting to the results potentially being used against you and you just have to either be at peace with that or decline to move forward.


In regards to your final concern, you are wondering whether a previous boss is sabotaging your success during the reference process. There is no requirement that you must give a prospective employer your former supervisor's contact information and I might advise you not to do so if you are worried about this particular reference. Providing a reference may be a condition of employment and withholding references will be a huge red flag to the hiring company so simply offer an alternative reference instead - someone you trust more, even if they weren't your line manager perhaps they had some less dotted-line supervisory experience with you.


Ask permission from all your references, provide them with a job description, and email them a bulleted list of 3 or 4 of your major recent accomplishments or strengths. This will help them prepare and promote you to the new company. Maybe your old boss isn't saying anything hurtful they are just blind-sided by the reference request and have no idea how to help you or what to say. In any case, I do recommend you have a conversation with that person before you consider providing their contact information to a potential employer again. I will point out that many large companies have a policy that managers may not provide references for liability reasons. Your former boss may have been instructed by HR only to verify the dates of your employment and not to comment at all on your performance.

Try not to take rejection too personally.

Today there are many qualified candidates seeking positions and the competition is stiff. A firm may look at 5 fabulous job seekers, any one of which would perfectly suit the role but they can only choose as many as they have requisitions for. Therefore, perfectly good candidates will regularly be turned away. In other words, not receiving an offer for the job doesn't necessarily mean you wouldn't be great for the job or that you did anything wrong at the interview. Finally, you can't force an offer, sometimes they just aren't going to love you and there is nothing you can do to overcome a lack of fit. Personally, I'd rather focus my energy on finding a great job where my unique talents are really appreciated than muddle through in an OK job where they weren't super excited about me as a candidate in the first place.


Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.

Travel Safety Refresher

So I've blogged before about travel safety but today we are all getting a refresher as a result of my monitoring trip yesterday. I've easily been to Denver 20+ times in the last 2 years for business so I'm very comfortable getting around in the airport, on the highways, and to my favorite restaurants. The point of this blog is that I may have gotten too comfortable and let my travel safety guard down. I was visiting a new site in a different part of the city I have never been to so I decided to try a new hotel. I didn't really research the hotel since I am familiar with the brand and have a certain level of pre-set expectation (mistake #1 - always read reviews on a travel site to make sure the hotel isn't too dodgey). I didn't actually even print my itinerary or write down the address because I always travel with my iPhone and GPS. Mistake # 2 - Long story short the GPS 'couldn't get better accuracy from the satellites' and I got lost in a not-so-nice neighborhood and I regret not having brought my trusty paper google maps print-outs. I pulled over in a safe place and got back on track and arrived at my destination using the iPhone. It was all really unsettling.

Rewind to earlier in the day, after work at the site I went out to the car and realized the battery in the key fob was dead. I could have tested this at the car rental place but it didn't occur to me as the car only had 11K miles on it (Mistake #3). I had rented a new Nissan Maxima so there is no key, just a black plastic stick thing. After fumbling around next to my car for several minutes and whipping out the phone to call Roadside Assistance I realized there was a tiny button on the back of the fob that released an emergency key and I was able to get in the car (maybe this is obvious to everyone else in America but I was confused and tired and wasted a lot of time messing around with it). Luckily I was in a very safe location because I was not paying attention to my surroundings at all and I was just focused on getting in the rental car. This was pretty upsetting to me because it was clumsy to open the car for the rest of the trip and I no longer had the panic button function which is an important safety feature.

The hotel lobby scene can be fun and
inviting but for a single female business
traveler it is more safe to just dine alone
in your room.  You can get some work
done or unwind and feel secure.

I stopped in to a restaurant and grabbed some take away food to enjoy back at the hotel that night. It was still daylight but I had to park far away from the entrance. I decided I would be comfortable with that whereas at night I would have insisted on a valet (Mistake #4 - no valet at this hotel). I hopped out of the car and started walking toward the lobby. Mi stake #5 - I had seen lots of pedestrians in and around the hotel when I drove in but I did not even bother to look around to see who might be loitering near the vehicle or in the area before I got out. I cannot impress this upon you enough, you must always be aware of your surroundings. As I stepped on to the sidewalk a voice to my right called out "How are you doing today?". My initial instinct was to turn to the speaker and smile (I'm from the South - we're polite) but something kicked in and I realized the safest course of action was to keep walking to the left and pretend I had not heard the caller. The man started following me and he was calling, "ma'am, ma'am?". Maybe he was a beggar or just a senile old guy, or a complete prick (who approaches a single female traveler and scares the crap out of them like that?!). I will never know because I did not scope things out before I had gotten out of the car so I could never identify this man. I used the reflection of the hotel glass to check his distance and he slowed his pace as I came within eyesight of the lobby. I would not have gotten on the elevator with anyone else at that point but luckily the ride up to my room was uneventful. I did not report the incident to the hotel. I didn't have much of an appetite at that point but it was good to lock the door and take a deep breath because the whole interaction had been really scary for me. I will NEVER be comfortable staying in this hotel again.

I have a real affinity for hotel points and status. I will stay in a different hotel every night just so I can qualify for status quickly but I have another reason, too. A trusted monitor I know told me a story about a CRA friend of hers who was raped in her hotel room. The lady was all settled in the room, showered, watching TV, when the man just appeared out of nowhere. Maybe he had been in the closet or under the bed but he knew she had been staying there alone for several nights and had somehow gotten access to her room. The story is especially creepy because he had been watching her for up to an hour before he attacked. It is just such a disturbing story. I will never stay in a hotel for more than one night because of this story my friend told me. I also check under the bed, behind the curtains, in the shower, and in the closet before I deadbolt the door. I know I must sound crazy but I am not willing to get hurt for this job and I take every precaution I think is appropriate.

I haven't traveled for business in a while so maybe I am especially paranoid on this trip, or perhaps it is because I recently acquired an expensive piece of jewelry that I am not entirely comfortable wearing yet, or maybe I just have instincts that are spot on. OK, I am off to the airport now and I will be paying attention and traveling safely. I invite you to comment on the post if you found it interesting or helpful, if you have your own story to tell, or if you just can't stop laughing at me right now for over-dramatizing.

What are your weaknesses?

That's a common interview question, huh? I've got some pretty snarky answers but I'm not sure any are appropriate for HR or a hiring manager (For example, "one of my weaknesses is burning bacon, I'm dangerous in a kitchen"). I've been doing some introspection lately and I have a new answer prepared for this question should it come up at an interview or in the context of a performance review or at a dinner out with friends so I won't have to say something lame and generic like, "I work too hard". ;)

If asked, I would say my weakness is really more of an area of continuous development. I am overly-enthusiastic and a huge Type A person so I constantly have to audit my communications to make sure I am not 1) giving too much away 2) muddling things with extra details or 3) overpowering others. This is especially important when I send email to my sites or business colleagues. I try to keep email correspondence succinct and use bulleted or numbered lists when I am seeking clarification on multiple points. In a team context, I make an effort to listen to other's input before I jump in and offer my $.02 so that way less emotive folks can contribute to problem resolution. Finally, in a negotiation, you always have the most power when you can sit silently and take in all the information. I like to slow down and thoughtfully consider things rather than always acting impulsively.

So I think this is a good answer because I am describing something that I can control and work on. I am demonstrating self-awareness and goal-driven behavior; I think both of those skills are important to hone and develop. If I said, "I am short" I couldn't exactly do much about that other than wear high heels so I think it is a poor answer to the question (I'm actually tall, but you get my point).

Let me know what you think of my new answer and it's Friday so if you are feeling slap-sticky send me an email or post some outrageous answers you would love to give to this question.

Summer Vacation

I've been so busy monitoring and traveling the past year and a half that I accrued quite the vacation bank. My project is at a lull so the timing feels right to take a little holiday. I found a cheap last-minute airfare to Europe so I am flying to Stockholm and will spend a few days there then fly to Frankfurt, Germany. In Frankfurt we will rent a car and drive West to check out castles and explore the Rhineland. We'll take a few days in Amsterdam and then fly home. It will be pretty whirlwind I'm sure but that is just my style - always on the go.

One of the biggest perks of my Regional CRA position is the hotel points, car rental credits, and airline miles I accrue. I am delighted that all 8 nights of hotel are free because of the points I amassed traveling for work. The airfare between Stockholm and Frankfurt was paid for by my Membership Rewards points on the corporate Amex (1% returns on all spend). We're flying first class using the upgrade coupons I received for flying so much last year, and we received a discount on a really nice Mercedes to zip around the autobahn because of my status in the car rental program. I could not be happier with how I'll be cashing in on these benefits. I hear other monitors say all the time how they bank all these perks but never get around to using them. I'm a firm believer in earn and burn. Can't wait to blow through all my freebies!

I also bought a really cool set of Sharper Image suitcases from Woot.com - fingers crossed they arrive before we leave. Maybe since I am saving so much money on the trip logistics I can bring an empty one just for shopping and see how far I can flex the Euro and the Krona. Ha det så bra - Adjö´ så lä´nge! Perhaps my Swedish blog readers can let me know if I am using that phrase properly. Danke! ;)

Lead CRA Q&A: CRA Work/Life Balance

I recently received an email from a blog follower asking how I maintain work/life balance as a traveling CRA and whether I get paid more when the weeks are longer. The email is a little ironic as I actually have been really under-utilized lately and have spent most of the past 3 months sitting at home pushing papers around and trying to think of billable work to do. I am currently assigned to 1 study and I only have 2 sites enrolling - I can drive to both of them and visits are only every 4-6 weeks so I've been doing some co-monitoring and asking my manager to help me find more work or an additional assignment. You have to be careful what you ask for...I could be very busy again soon.

In any case, I've been monitoring for about three years and I have done a lot of traveling (if not lately) so I was definitely able to address the reader's question and I will summarize my response for you all.

I work for a CRO and I am paid the same salary regardless of how many hours I work. It is normal for me to work 10-15 hours over 40 and not be paid. This happens because I have to stay on top of my reports, there are unexpected layovers when traveling, or there is just a lot of work to do and you have to be flexible. It is important to have a good dialogue with your manager and make sure that every week isn't a 60 hour week - that is not in your best interest or the companies best interest because you will burn out.

On average I travel 3-4 days each week and spend a couple of nights at hotels away from home.

Once you have 5+ years or so of experience you may choose to work as an hourly consultant. However, while you are new and learning, typically you take a salary job. The trade is that if you work for a large company they provide structured training so you are gracious about working the extra hours because the experience you are getting is so valuable. Also, I typically only work on 1 or 2 studies at a time so naturally my work ebbs and flows. For example, this month I had a lot of trips back and forth to the East Coast (9+ hours travel time each way) but last month I was just working at sites near my house so I traveled only about 10 hours collectively the entire month.

When you travel all week sometimes the last thing you want to do is go out with your friends or plan personal trips so you have to make the effort and be sociable even if you are tired. The travel does get in the way of me taking continuing education courses at the community or local college since I am typically on the road on weekdays. A membership to a local gym would be wasted on me since I am never home - I just make sure I stay at hotels with nice gyms. Sometimes I miss Happy Hours with my friends or important networking events or ACRP meetings because I am not in town. When you are at home you may not want to eat out, upkeep the house, or take care of all your other 'real-world' responsibilities. However, you have to compromise and do these things as you can because you love the people at home and want to make them happy - even though you may be exhausted. Plus, when your home is a sanctuary from the road you'll feel better and more relaxed, too.

You may not be able to own a pet or a plant because you just won't be home to take care of them. 

That negative stuff stated, I won't travel 85% of the time forever. This is just for another 2-3 years until I step into a Lead role that requires less travel or work towards Project Management. If I go independent I could just make my schedule such that I don't travel Mondays or whatever I like and that would keep the hours within reason. I'm compensated well and I am developing great career skills and networking connections so the travel is in balance for me. Not everyone is cut out to be a road warrior but I still fancy it. There is no substitute for experience and I am gaining that everytime I travel and visit a site.

Lead CRA Q&A: Challenges to a New CRA

One of my connections is taking a CRA Development course and her homework assignment was to ask a tenured CRA "What did you feel were the biggest challenges of the position when you first started?" I am providing my answer and would love to hear if other seasoned CRAs agree or if there are other hurdles that I didn't even mention.

My answer:

When visiting a major medical center it can
be a major challenge just to figure out the
parking or navigating the campus (pictured: UCLA).

I am not a nurse and I have never worked with patients in a clinical care setting so it was a challenge to learn how office and hospital charts were organized. You have to know what is supposed to be in there in order to recognize what is missing. On the flip side, there is a lot of stuff there and you need to be able to figure out what is noise and what is actually important in your role as a monitor and the context of the study. Charts are sometimes hundreds of pages long and I have worked on studies where it took 2 days just to perform chart review on a single patient. Again, developing that skill to filter what is important and needs to be in the database versus what is just extra information is really critical to your success. Once I started on in-patient studies I also needed to learn how to read surgery reports and hospital medication administration records and the slew of acronyms and institution specific items that accompany both. I'm still learning, every time I go to a new hospital or study center. Charts are organized similarly but there are always institution specific nuances and learning how to read the charts is one of my main objectives at my first monitoring visit to each new site.

When reviewing AEs, labs, and Con Meds, you frequently come across things you are unfamiliar with. It was important when I first started to be industrious and know where to find answers. You can't possibly know everything but you have to be able to use your resources like Wikipedia, Epocrates, Merck, study staff, extension courses, and other training databases/materials provided by your employer or the sponsor to fill in those deficiencies as you come across them. You can also better prepare for a new study by doing internet research on the therapeutic area. On a recent study, I downloaded medically relevant podcasts to help me prepare and learn some of the common issues and medications with my patient population. When you are learning about a new therapeutic area, start with patient advocacy or education websites because they are nonscientific and then work your way up to journal articles, sponsor slidedecks, the IB and more intense material.

Finally, it is important to find the right balance when writing your monitoring reports. You want to give enough information and specifics to show you were there and followed all relevant SOPs and guidelines but you want to keep it succinct and avoid a novella. You also want to cover yourself in an audit later but different sponsors want different levels of detail. Your Lead CRA and Project Manager will help you land on the right amount of detail through their reviews but the first couple reports on a study are always a challenge because of this issue. You can read more on my blog about efficiency tips, timesheet tips, MV report tips, and Career Advice.



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

• How to Break in to the Industry January 2009
• Negative Performance Feedback April 2010
• 5 Career tips for a Young CRA July 2011

Monitoring Visit Checklist

I participate in a number of clinical research forums and I just received an email digest this week from one that linked to a monitoring visit checklist of sorts. Many of you have emailed me and left comments asking for a checklist but I can't figure out how to post one on blogger. Instead, please review Norman Goldfarb's Journal of Clinical Research Best Practices here and download his checklist or read my post about Conduting a Routine Monitoring Visit.

Norman M. Goldfarb is Editor of the Journal of Clinical Research Best Practices.

You can subscribe to his updates here and I think you will find them as useful as I have over the years.

Hard Times Right Now for a CRA

I received my formal performance review last week and an overall rating of "Exceeds Expectations" with some great input from past Project Leaders/peers and highlights of some of my more notable accomplishments in 2008. I was unprepared for how well I ranked on my metrics so I will keep a closer eye on that in 2009 (we are measured, among other things, on timely report submissions and billable time...my productivity metric was well over 100% whereas we are only required to be at 86% so that was really a little too high for a good work/life balance).

With gas prices like these I feel
like I am working for peanuts.
Times are tough financially.

I am obviously thrilled with the review and so delighted that my hard work is being recognized. Unfortunately, we just received an organizational-wide announcement today that there will be significant restructuring before mid-May and they have suspended all bonuses, promotions, and salary increases for the entire company indefinitely. I am saddened by this news since I joined the company mid-review cycle in 2007 so I have not had a salary increase in over a year and a half of loyal service. This coupled with a significant increase in my cost of living leaves me in an uncomfortable position (gas prices in CA hit record highs within the past 12 months, in San Francisco our sales tax has just increased considerably, etc.).

Naturally, this feels like a good time to update my resume just in case so I've been circulating it around my network and trusted connections for input so I am prepared to search for a new position as needed. I've recently started a really exciting new assignment in the past several months so I am hopeful that my regional CRA II position at the CRO will not be redundant but you just never know. My plan is to stay enthusiastic to the best of my abilities and keep my ear to the ground. I'll keep you all posted here.

IRB Integrity

I am starting to monitor a new study at 4 Academic Institutions. The Academic Institution Review Boards (IRB) have a reputation for being very stringent and the IRB process can be quite lengthy (not to mention the contracts process and everything else related to start-up). It has been interesting to contrast the reporting and documentation requirements required for these study sites versus other studies I have worked on that used a central IRB. For example, some IRBs don't even want the IND Safety Alert letters submitted to them unless the cause of the Serious Adverse Event is at least possibly related to Study Drug, some IRBs have approved new versions of the ICF and yet only require consenting newly enrolled subjects on the updated version but no re-consenting of currently enrolled subjects, some IRBs don't even want to be informed of the Protocol Deviations unless they directly impacted subject safety or the integrity of the study, etc.

In any case, I came across a media piece about ethics committees this week on Anderson Cooper and found it provocative so I am posting the link for you. These Academic IRBs may be difficult to navigate but at least they aren't fly-by-night operations like the ones shown here. Click here to see the video.

14-Apr-2009: Just a quick update that Coast IRB has been shut down. Here is a link to the Denver news article a friend sent me. Click here to read the story!

Close-Out Visits this Quarter

I've been performing close-out visits for a variety of studies lately and I am ramping up on a new study. Sorry I haven't been able to post sooner, but in this economy I am happy to have a great job that is keeping me busy with such interesting and varied assignments.

I have been closing other people's sites on studies I didn't even work on so one of my more time-consuming responsibilities has been a full regulatory binder review. Typically for sites I manage over time, I know what is in the binder and can verify that the documentation contents at the study site match the contents at the sponsor's Trial Master File (TMF) exactly (since I work for a large organized CRO we also have a fantastic suite of applications and reports to help us with this reconciliation process). The reports and previous monitoring reports help me identify what documents need to be updated and I email the list to the coordinator several weeks before the visit. Since I need to retrieve a copy of any updated documents for the TMF I just ask the coordinator to slip a second copy for me in a folder or email me an electronic version and this has dramatically reduced the time I would spend taking apart their binder and hovering over the copy machine. Some sponsors want the site to keep originals of all study logs and some sponsors want the site to keep copies so they get the original. Some sponsors consider a signed CV to be good for 2 years whereas some require annual updates. Some sponsors want an updated 1572 and/or Financial Disclosure Forms at the end of the study and some sponsors don't ask for this at all. There are few hard and fast rules for documentation (aside from the ICH/GCP guidelines in section ICH E6, Section 8.4) so I have to understand the study specific requirements in advance of the visit (these are communicated in team meetings and documented in the study monitoring plan) to know which documents to retrieve.

Another area that has required a lot of time and attention is the return of the Investigational Product (IP). To assist me with the drug return I have requested reports from the inventory management system several weeks in advance of the visit and submitted them to the pharmacist or Study Coordinator. I ask them to organize the medication numerically by lot/kit # into used and unused lots and to check that all drug receipt and dispensing forms are accurate and complete and that the quantities match the CRFs. I follow-up over the next several days via phone or email and ensure they have completed the task. Typically they print the inventory reports and highlight them or make comments when there is a discrepancy. I always have them fax me any notes and copies of all the drug logs so I can review them. I can prepare the bulk of all my drug return documentation before I even arrive at this site and that saves a lot of time during the visit.

The last item that has been a real time-synch is reviewing the safety binder to ensure that every safety alert was acknowledged by the Principal Investigator (PI), submitted to the Institutional Review Board (IRB), acknowledged by the IRB, and that all that documentation is filed in the binder and submitted to the TMF. Luckily, I have been able to do work prior to the visit to help this task go as smoothly as possible (one study I closed out had over 5000 safety alerts so that could easily have been several days work whereas another study only had 42 and I knocked out the review task in about an hour). As you know, this review of safety letters should have been occurring all through conduct and regular monitoring visit but unfortunately, when it is not your site, you're really forced to re-review every bit of documentation unless the previous monitoring report(s) can confirm the documentation is current. For each site I closed I sent a safety letter tracker. It was just an excel spreadsheet where each alert was listed by date in the order in which it was sent to the site with a brief description that included the event #, event name, event onset date, patient initials, and a column specifying whether the event was an intial report or follow-up report. Finally, I added three blank columns to the end of the spreadsheet with the titles 'Date Ack. by PI' , 'Sent to IRB Y/N', 'Date of IRB Ack.' In each case, I required the study staff to complete the tracker and email it back to me prior to the visit. By using this technique we easily discovered missing documentation in advance fo the visit. I was able to forward blank copies to the site to prepare before the visit and we had time to obtain sign-offs and do the necessary IRB submissions. It was helpful to be sure pending safety letters didn't delay official notification to the IRB of study closure.

In summation, close-out visits at my own sites go pretty quickly and are fairly routine whereas there is a lot more work involved with closing out someone else's sites. To make the visits easier I worked with the site staff several weeks before the visit to address the documentation gaps in the regulatory binder, review all the IP documentation, and to ensure that all safety letters had been properly acknowledged by both the PI and the IRB. By thoroughly preparing in these 3 time-consuming areas, I had plenty of time while on site to accomplish all of my close-out responsibilities (click here to learn more about COVs in my blog post from last year). One other huge plus is that I knew what to expect once I arrived on the site, had developed a rapport with the staff, had prepared organized checklists, and then I left the sites with minor or no pending action items whatsoever. This all contributed to being able to easily and quickly finalize my close-out visit reports. I hope my experience helps you better prepare when you are asked to close-out someone else's site (or even your own). Do your homework before the visit and it should go like clockwork.

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.

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.

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 LinkedIn.com).

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.

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.