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. 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 is a risk for you). 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.

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?

September 3, 2009 6:46 AM 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

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.

In parting, try not to take rejection too personally - especially in this market. 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.

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.