5 Career Tips for a Young CRA

I came across a fun little article on biospace that offers career advice: 5 ways to be a rockstar at work (via Biospace).  

This post echoes the format of that article and I hope you will find it interesting and leave me a comment or email some feedback. 

Although I have transitioned to in-house, the bulk of my experience as a CRA is in Regional Monitoring.  Reflecting back on the career tenants I stand by, I am sharing today my 5 best career tips for a new travelling monitor.

1. Be a Partner

• An auditing approach to monitoring will strain your relationship with the site staff.  You know the regulations that govern our work and you understand the study that you are monitoring including all the expected procedures, assessment windows, and special instructions provided in newsletters and in other study correspondence.  Your attitude can be to train the study site personnel and share with them this information to help them protect subject safety and data integrity, or you can go in and point out everything they’ve done wrong and focus only on the poor performance.  You can write a damaging monitoring report, cover yourself, and simultaneously ostracize the site but you will not have partnered with the site or introduced extra quality; you may be perceived as a bully or hall-monitor.

• 

  Don't "police" your sites too strictly.

  This approach is detrimental to

  quality relationship building.

  Remember that coordinators and Investigators have responsibilities beyond your specific trial.  I have addressed this in other posts such as 'Motivating Your Study Coordinators'.  If you can’t put yourself in someone else’s shoes you won’t be able to influence them to help you with your goals during the visit or in future visits.
• At crunch time you will cultivate the relationships you have built. Need access to the site at a greater frequency or increased duration?  Need your coordinator to stay late and do some extra data entry or query resolution?  If you have been friendly and respectful to date, you improve your chances of getting what you need out of your sites – even at short notice. 

2. Know your Metrics / Deliver Quality Results

What is expected of you? How do you
rank in performance compared to your
peers?  Are you accountable at work?

• You are being measured against your peers.  Approach your work in a task-oriented manner and ensure that you know which deliverables are due, when, and in what manner.  Deliver early and track your contributions. 
• Be current on all training and don’t expect a prize for meeting this basic job responsibility.  Even if “nobody else is getting their SOPs done”, stay current on yours and don’t link your performance (or failure to perform) to others.
• You’ll come to find that cultivating quality relationships and trust with your sites will go hand-in-hand with producing excellent metrics.  Focus on quality first and the metrics will follow. 

3. Raise your Flag / Get Noticed

Me me me.  Don't forget to highlight the successes
 of your supervisor and the collective team.
Contributing to other people’s happiness
 and “ team buzz” will return to you in dividends. 

• Pause and reflect as needed to appreciate your body of work.  I keep a “praise” folder in my email to store thank you notes and stories of major deliverables I have met or produced.  I reference the “praise” folder as a pick-me-up when I am feeling overwhelmed and challenged.
• Since you are always identifying your deliverables and finishing everything ahead of the deadline and tracking your contributions as I have suggested, you can provide this information to your immediate supervisor at 1:1s, in performance reviews, or in status report emails. 
• Don’t overreach.  If you are promoting yourself to your bosses boss, you may be overstepping and actually undermining your current boss or creating animosity among your peers.  Tread carefully here.  Be humble and use good judgment.  

4. Don’t Commiserate / Nobody likes a Debbie Downer

Moaning about what isn't working is easier
 than focusing on what is going well or
coming up with solutions to improve
 situations that are not ideal.
Resist the temptation to commiserate.

• Your peer CRAs may live and work in cities far away.  They will have different financial circumstances, family backgrounds, tastes and preferences, and values.  Typically the easiest common ground when forging a relationship with your peers is to talk about work and the projects at hand.  Inevitably, this will lead to grumbling or complaining about the demands on your time, or a boss who just doesn't get it, or a lead who seems checked out, or a site that is difficult to work with.   You may feel you are “just venting”, but negativity is toxic, counter-productive, and a bad attitude will adversely affect your future career prospects.
• If you have nothing nice to say, don’t say anything at all.  In every job you have to evaluate the gap between what you want from your ideal position and what you have in your current position.  It is your charge to reconcile that gap by identifying concrete and measurable outcomes that leave you satisfied.  If you simply cannot overcome the gap because of a corporate culture mis-match, timing, resourcing restraints, etc. you have to decide 1) Am I going to acclimate and deal? or 2) Am I going to bolt?  You should only be asking those two questions once you have exhausted every avenue to change your position into what you want.  These are the only two choices.  If you take things to their natural conclusion, you can stop being petulant and accept your circumstances or you can have the maturity to leave your position; either option is ultimately in the best interest of yourself, your boss, the organization, the sites, and the study patients that we are ultimately responsible to.  The scenario where you stay begrudgingly, and half-perform will likely eventually result in your termination. Your metrics will suffer, your relationships outside the office will be impacted, and you will be unfulfilled and miserable at work. 

5. Be Patient  / Exercise Humility

The best managers teach you that
you can validate yourself and
recognize your own accomplishments.

• Your Lead CRA isn’t approving your trip request within two hours of submission? Give it at least a day and recognize that you are one of a team of many CRAs that your lead manages.  This, while your lead simultaneously juggles all of the other CRA Lead and ad hoc responsibilities.  Trust that your request is in the queue and chill out. 
• Not getting the promotion you are ready for or the recognition you want after over-delivering on an important study milestone?  Keep reminding your supervisors of your contributions through status reports, performance evaluations, in 1:1s, or in a team setting. 
• Great managers always have a pulse on your contributions.  Better managers always give you credit for a job well done.  The best managers provide acknowledgement strategically; they make you wait for it to teach you humility, maturity, tact, and solidify your role in the organization.  The quality expectations are very high with the best managers and therefore they reserve praise for only truly exceptional performance.  Feedback that you have to be patient for will prove to be your most valued feedback at work.

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

• How to Break in to the Industry January 2009
• Challenges to a New CRA May 2009
• Negative Performance Feedback April 2010

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.

Efficiency Tips: Spend less time on your Timesheet

I am employed by a service company and we bill our clients for our services. Therefore, we must track our time spent on sponsor related work and pass the costs through appropriately. I am asked to track my time in 15 minute increments so I can basically report up to 4 time categories per hour or I can bill a half or whole hour to a specific time code. In order to receive a good performance rating, I must report at least 85% of my 40 hr work week as "billable time".

My non-billable time codes are things like: Sick, Holiday, General and Administrative Duties (G&A), Internal training (not project specific), goofing off (ok, so that is not a category but if ever I am shy of 40 hrs and can't account for the time then G&A is a good catch all), etc.

Billable time is coded by project (since I might work for several sponsors/projects at once) and then broken down into time categories as follows:
Project Specific Training / Sponsor Teleconferences - Reading protocols, watching power points, reviewing the Monitoring Plan, etc.
Preparing and Following Up - This category is used for making travel arrangements or writing confirmation/follow-up letters, or working on reports.
Traveling - Usually your project will have limits to how much travel time you are allowed to pass through. At my company, when long trips are unavoidable, you can lower your travel time by using the time in transit to complete other project related work such as studying or writing reports (billable to either of the 2 categories listed above) - obviously this works when on an airplane or delayed and not necessarily when driving!
Managing Sites - This is phone or email contacts to your study sites or running special project specific reports.
Conducting a Monitoring Visit - Actual time spent on site during SIV, COV, or routine MV.
Query/Database Management - Helping the site solve/close queries raised by data management, reviewing the clinical database, running reports, etc.
Expense Reporting - see my next post!

OK, so now that I explained how I categorize time, let me explain the time tracking system. You can think of it as a glorified version of Excel that lives on a web server. So to enter my time, I have to log into that system and enter all of my hours. We are asked to do this at the end of every day so we are as accurate as possible. Well, I don't have internet access all the time so sometimes I let a few days pass and it really is hard to remember what you did for the past 48-72 hours by 15 minute increments. To solve this conundrum, I made a copy of the fancy web-based timesheet template in Excel and I just leave it on my desktop. Each day before I log out of work, I update my time in my Excel template. Then every 2 weeks (or as I have time) I log into the web-based system and transfer it all. I know this is multiple steps but it seems to work better for me. You could also use a journal or jot notes about how you spent your time in your day planner. Any other tips?

Staying Flexible and Creating my CV

Working at home isn't all bad but I
have to stay focused and shoo off
distractions like my little yorkie, George.

I have been kicked back at home in my bunny slippers pouring through the SOPs and online training courses for my new CRA gig. As of orientation, I was assigned to one study but now I have been picked up for 2 different ones (luckily in lieu of the first rather than in addition!). One of the first tasks every new CRA at a CRO must complete is entering your Curriculum Vitae (CV) into the corporate database. CV is fancy biotech jargon for résumé (Wikipedia tells me that CV is Latin meaning "course of life" and résumé is French meaning "summary"). Basically, you want to chronicle all of your past relevant work experience but more importantly, you must complete an inventory of all of your relevant skills and therapeutic experience. I had to indicate which Phases of clinical trials I have experience in, what types of studies I have worked on, and quantify everything...3 months? 6 months? 1 year? The other fun part of the CV was the summary section where you write a little paragraph about yourself in the third person.

BIOGRAPHY
Nadia BoBadia, BS is a CRA II responsible for monitoring clinical studies with various indications. Before joining the company, Ms. BoBadia was employed as an in-house CRA I at a specialty cardiovascular biotech company, where she managed site budgets/negotiation,forecasts/accruals, and processing/disputing invoices, along with monitoring 3 Phase I cardiovascular and pulmonary trials. She traveled internationally to support FDA audit inspection preparation visits and NDA triggered activities for 2 large Phase III studies. For two years Ms. BoBadia was employed at a CRO and an Electronic Data Capture (EDC) company performing data management functions including designing CRFs and clinical study databases for a variety of therapeutic areas. Prior to that she was employed at one of the top 3 pharmaceutical companies and a large biotech performing commercial product and field sales personnel support for pulmonary and CNS indications. She has additional experience as a project assistant on a Phase III Ophthalmology study. She joined the company in 2007 as a CRA II.

So this electronic CV is what the sponsors (pharmaceutical and biotech companies that have contracted with my service company to run part or all of their studies) use to decide whether or not you are appropriately trained to work on their studies. So even though I have a job, it is like I am constantly interviewing in order to be able to do my job (get billable hours/activities). I know in time my skills inventory will be so impressive that sponsors will be delighted to pick me up for their studies so that is definitely satisfying.

Half of the folks from my training class are already out traveling and monitoring but I have to finish my study specific training (reading the protocol, monitoring plan, sponsor SOPs, etc.) and receive my site assignments. Right now I am projected to start traveling the week of Dec 2nd so I am just enjoying the downtime while it lasts. I have been enrolling in benefits, setting up my home office, playing with my new printer/fax/scanner, ordering office supplies, and generally keeping myself busy.