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.

New Hire Orientation

I have been at new hire orientation all week. We started at 8:30a on Monday with HR. They reviewed new employee stuff including company history, benefits, and general company information. I was greeted at lunch by two long-time employees who took me out for a nice meal and told me more about the company culture and their studies. Most of the CRAs at training already knew what their assignments would be but I didn't even know who my manager was at this point.

After lunch, IT came in to deliver rollerbags and laptops. My laptop is more like a workstation (but it is tiny, light, and so cute!) because I have no administrator access and can't even change the system time or download a thing. Sites like YouTube are blocked but luckily Blogger works! Unfortunately we use Lotus Notes so that will take some getting used to. In my previous CRA position I was addicted to my MS Outlook calendar and contact functions. I have a PDA phone by Motorola so I would sync this constantly and it will be hard to go without. Lotus is 21 CFR Part 11 compliant and my CRO has chosen it because of its database capabilities. Every study gets a repository where essential trials documents and forms are stored and this is all shared through Lotus. This is better than a share drive because the repository can be 'replicated' which is a fancy term for saying I can view it even if I can't get on the VPN. For homework I had to read the employee manual.

I talked a few of the CRAs into joining me for dinner so it was a fun and relaxing evening. The next morning we reported for CRA II training. There were 6 of us in the class and we are all Regional associates (4 from the East Coast and a gal from Phoenix). CRA training lasted only about 3 hours and was just a quick review of ICH/GCP and a 'how-to' for source document review. After lunch we learned how to track our time. The system we use is not terribly complicated and I finally found out what study I would be working on and since it is only one at this point, reporting my time won't be so difficult. As CRAs, we are expected to be 85% billable. That means I need to be traveling or doing client work most of the time. I have to 'bill' these items to the sponsor by accurately completing my timesheet. This is easier said than done; I have been telling people it requires a bachelor’s degree because each 15 minute increment has to be coded to the specific task you are completing so it can get complicated. For homework we had to mock up a sample timesheet. Luckily completing your timesheet is billable because it takes a while!

All the new CRAs are asked to take part in a bull-ride
challenge.  If you can last 30 seconds you advance
to the next day of training.  Just kidding!

The third and final day of training was a hands on demo of how to complete an expense report. Again, this is no easy task. It is made easier by the fact that I was issued a Corporate Amex. I will put all charges on my Amex (except where it isn't accepted) and keep my hotels under $150/day and meals around $50/day unless I have written manager approval to go over (which will be required depending on what cities my sites are in). There is no preferred airline but I will be using National car rental and usually Hilton hotels as they are the preferred vendors. A large CRO can have 'preferred vendors' because they require traveling employees to use Amex. In this way, they can run queries to see how many nights employees stay in hotels and things to negotiate special preferred rates. I will have $30/mth for a cell phone stipend, my broadband and phone line will be reimbursable including installation. I have been given a $1600 stipend to furnish my home office. Lucky for us, charges to the Amex pre-populate into the expense report so that helps. Corporate pays the card directly as long as I submit the expense report within 14 days of the trip. Airfare will always be non-refundable so I can submit the expense report the moment it hits the Amex and do not need to wait for the trip to actually occur first.

It was a busy 3 days but a lot of fun, too and I may never again venture to corporate headquarters so it was a nice opportunity to get a glimpse of how the home office runs. I will hopefully have project specific training soon and meet my line manager (at least over the phone anyway). Now I am busy reading SOPs and doing on-line training for the next few days.

The Acceptance

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

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

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