Monitoring Tools & Notes

As a regional monitor, I have primarily worked on studies with a conduct period of only a few months.  For these trials, I can typically monitor an entire subject’s source in just a couple of monitoring visits (IMVs).  However, I do use a few monitoring tools to keep me organized and assist with report completion.  I obtained most of these templates and advice from other talented CRAs I've been lucky enough to co-monitor with; special thanks to all my wonderful resources who have been open to sharing tips and tricks along the way.  For studies that last longer than a few months, these tools could be especially handy for resuming monitoring across multiple IMVs.    These are some of my standard and favorite monitor tools:

Generic Calculators & References

Never leave home without a date wheel!

• Height/Weight/temperature conversion
• A date wheel for calculating the # of days between visits (checking for out-of-window deviations)
• Nurse’s Pocket Drug Guide book
• Medical Dictionary
• Websites: webmd.com or drugs.com

Study Specific-Calculators & References

• Visit Window Excel Calculator
• Drug Compliance Excel Calculator (if you aren't an Excel guru then ask your Lead CRA or one of the Data Managers to help you out)
• Pocket-Sized Protocol (If you have a PDF or word version of the protocol any copy shop can produce a little spiral bound or gum-bound booklet for you for around $30-$50....worth every penny and you can probably pass it through an expense report - check with your PM)
• Study-specific CRF Completion Guidelines
• Essential Document Tracker and TMF Submission Form
• Recent Correspondence, Study Newsletters, etc. (nice to have printed on hand so if there is a gap in the Site Master File I can just I can just leave a copy behind at site)
• Blank Study Forms 
• Mocked-Up Study Forms (I have worked on several psychiatric studies that utilized SCID, MINI, or a similar scale/questionnaire to screen for exclusionary criteria.  Since the questionnaires can be so long and involved, having a properly (or prohibited) completed form to compare to the source can be a huge time saver and serve as a checklist. 

Monitoring Report Template and Follow-up letters & Action Item Logs

The most important thing you can bring to every visit is a blank copy of the monitoring report, in my opinion.  Your goal should be to complete as much of the monitoring report as possible while on-site.  If you take your monitoring notes in the report template, you have less paper to keep up with and this will really increase the quality of reports.  The longer you wait to write a report following the visit, the lower the quality -- document your findings while they are fresh.  A monitoring report template also serves as a great checklist to ensure that you don’t forget to do all the routine tasks (like sign the monitoring log, check the temperature records, etc.)

IMV Specific Monitoring Notes & Stickies

If you use a monitoring notes log,
consider producing the log on colored paper or NCR
so it is easier to keep track of in a pile of documents.

Post-it Notes stickies are great for flagging discrepancies and other items that need attention in source documents (blank fields, missing signatures, headers incomplete, etc.) but these can fall off or the coordinator may remove them once complete so that makes going back to verify they have been addressed difficult (I usually flag on the top and ask coordinators to move the sticky to the side to indicate it has been addressed rather than remove it).  I like to number my stickies and/or add little notes to them.  Then I can track the stickies in a subject-specific log like the example here.  

Some CROs and companies discourage the use of formal monitoring notes and stickies (as they can potentially lead to avoidable audit findings if left behind in a source binder) so do check with your Lead CRA to make sure using these types of tools is permitted.  

Don't write things down twice, try carbon paper!

I review my monitoring findings with the Study Coordinator or PI at multiple check-in points during the visit and sometimes they like to take monitoring note sheets with them back to their desk to work on the items while I am there.  If we aren’t able to resolve everything while I am on-site I photocopy the monitoring worksheet so I can write up the action items in my report and review that everything was addressed at my next visit. 

I have also made my monitoring notes on NCR carbon paper before and this has been extremely handy for me in order to leave a copy for the coordinator.  You can have your monitoring note worksheets pre-printed on carbon paper at any copy shop or you can buy the paper yourself to use in your own printer or to fill out by hand.  Also consider just bringing along a perforated carbon paper lab notebook or tablet if you anticipate leaving lots of to-do items behind.

Subject-Specific Monitoring Worksheet 

So again, my goal is always to write as few notes as possible while on-site.  I try to just document everything directly in the monitoring report template, follow-up letter template, and Clinical Trial Management System (CTMS).  That said, it can be useful to have some subject-specific notes when pouring over lots of medical records or extensive source documents.  Your subject-specific monitoring notes worksheet can also be a helpful reference at future visits or when completing authoring a report once you leave the site.  If you develop a little study-specific template, you can easily track out-of-range lab values across visits, ensure that all required protocol tests and procedures were completed, more easily fill out site payment or CTMS trackers, monitor consistently and more efficiently, etc.

Aim to only track things that wouldn't necessarily be recorded in the CRF or monitoring report but could potentially adversely impact subject safety or data integrity.  For example:

•  If lab values are abnormal at a visit, how long do they take to return to normal? Are the AEs recorded properly?
• If AEs are occurring, are new Concomitant Medications being added? Is the dosing of Investigational Product being adjusted?
• Who is completing each assessment (same person each visit?)
• Are all study drug kits being returned at every visit?
• Are there out-of-window visits or other compliance issues?

Base your Excel template on the study Schedule of Assessments

I also try to limit myself to a single page of notes per subject, front and back permitted.  I typically take the notes in Excel so I can copy and paste them into my report but if you prefer to have a printed template, consider the colored paper trick and use something durable like cardstock so you don't inadvertently lose your treasured notes in a paper shuffle.

What's in Your Bag?

So what other tools and templates do you find useful when monitoring?  Leave me a comment here, send me an email, or share your monitoring tips on my Facebook page.  

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

• Tips for Better Monitoring Visits March 2012
• Sponsor Furnished Source Documents  April 2011
• What to Pack for a monitoring Visit August 2008
• Routine Monitoring Visits March 2008

3 Simple Ways to Improve the Approach

I was invited to speak on a panel this week at the Outsourcing in Clinical Trials West Coast conference.  This was my second year in attendance and the conference was an excellent investment of my time with lots of great networking and informative sessions.  The topic for my panel was “Examining mistakes some vendors make when approaching new clients to build and strengthen outsourcing partnerships”.

For the blog, I thought it would be a fun exercise to summarize a few key points brought forth by my fellow panel members.  However, I will flip it around by adding my comments on how each of the take-aways apply to our roles as monitors when establishing relationships with new clinical trial sites.  I’d also love to have your perspective so please email me at theleadcra@yahoo.com or leave a comment below.

I - Do Your Homework

You don't have to be a total stalker,
but a little internet research will help.

Our panel agreed that vendors can do a better job of learning about our company background, structure, and culture before they approach.  Most companies have a website and a lot of this information is listed there in a Mission Statement, Pipeline overview, Investor Reports, Press Releases, etc.  Anyone can google a company for news within the past 12 months and get a good idea of what the current challenges to the business are. You can also search by sponsor at clinicaltrials.gov to read a lot of details about past and current trials including who to contact, who the investigators are, and basics of the trial design. With this information in hand, vendors can tailor their approach to only offer the services and products that are most likely to be of interest rather than going through the whole dog and pony show.

So as monitors, here are some of my ideas on how you can you better prepare for a first site visit or any other in-person meeting with your site personnel for the first time.  It goes without saying that you should already know all the ins and outs of your protocol, be able to speak intelligently about the drug program, Investigator’s brochure, study tools, and the sponsor before you meet with any site personnel.  So let’s focus instead, on what you can now easily discover about the site.  Well, presumably you have the CV of the Principal Investigator and some of the key study staff.  Figure out when they graduated and where they completed their residency.  See where they grew up. Read through all their experience, have you worked on similar studies? Have you visited their home state? Do you have anything in common with their background that you could possibly use as an ice-breaker in the introduction?  If they are published, locate titles or abstracts so you know where their research interests are.  Consider bringing along a relevant recent journal publication or news article that you can pass along.  Google their office or research center to see if they have a website so you can learn more about their practice or recruitment strategies.  Are they on facebook, twitter, or other social media sites?  Many doctors have been reviewed by their patients on yelp; this can be enlightening.  Ask around with other regional CRAs you know who have worked in that therapeutic area if they are familiar with this site or any of the employees.  Maybe your company has an investigator database and you can glean some further insights there?  Go on clinicaltrials.gov and see what other studies they have done (you may need the location name of the site rather then the PI name to get any results or you can use the map). Now you can ask about their specific experience in other trials and head off any of those same challenges in yours.

By the way, you don’t have to tell them how much research you did or hint around too much (since you might seem like a stalker) but if you do this homework beforehand, you are going to be more prepared for the meeting and better able to find common ground and guide the conversation, trust me.  Since you now know so much about your site, you can easily tailor your communications to their trial experience level so you can be engaging and helpful rather than patronizing, overwhelming, or boring.  You’ll have more meaningful dialogue and can probably learn a lot from them when you ask them for more details about their past experiences.  Finally, if you put in this time and energy to kickstart a relationship then you obviously respect and admire other people that you work with; that will not go unnoticed downstream.

II - Avoid the Cold Call

The dreaded cold-call sales pitch.

On the panel, we all explained that we are busy and our time for vendor selection is limited.  We have a very basic expectation that business development people will be sensitive to our time.  Now don’t get me wrong, I love free lunch, sticky pads, clickable pens, squishy stress balls, and laser pointers, as much as the next guy, but my time is valuable and if I meet with each and every vendor that calls me out of the blue, my performance at work would suffer because I would run out of time to fulfill my basic job responsibilities.  The sad reality for new vendors is that we’re just more likely to work with vendors and people that we have known and worked with before.  When I get a cold call and they say “Is now a good time to chat?”  If I say “No” that is not an invitation to rattle off 10 bullet points quickly before I put down the receiver.  I would rather they say, “no problem, I’ll send a capabilities overview via email and hopefully we can schedule some time to chat after that”.  There was consensus on the panel that conferences like ASCO, therapeutic area programs, DIA, ACRP, outsourcing, etc. are a much better forum for getting to know one another rather than the telephone.  We also rely heavily on referrals from our colleagues in the industry so please spend less time on cold calls and more time networking for introductions from your satisfied clients for new business.  If on the off-chance a vendor catches me on a cold call and I have 10 minutes to chat, I will ask very specific questions about capabilities and metrics used to track performance in similar previous trials and ask particulars about their relationships with other clients.  If you call me, I expect that you already know about my business as I work for a publically traded company.  Again, they called me so they need to be prepared and have done their homework (see point 1 again).  I am not just sitting by my phone all day hoping some random vendor will call me and then ask me to explain what my company is working on; the information is out there.

So you are a CRA assigned to a new site and you were told by your lead to make a site contact within 10 business days.  OK, so if you just call out of the blue will the coordinator be pleased to hear from you?  Most likely, no.  My recommended approach is to send an email introduction first.

“Hi, my name is NadiaBoBadia.  I am a CRA based in San Francisco and I’ve been informed that we will be working together on the trial.  I am really looking forward to visiting your site next month.  I’d love to call and introduce myself to you this week.  I’ll try you this Thursday at 10am EST.  I also have availability after 2pm and would be happy to phone you at that time or another time if it is more convenient, just let me know.  I am hoping we can chat for 10-15 minutes regarding next steps for working on this trial together."  

See what I did there?  I am 100% planning to call them; they can expect it and prepare for the call.  I also provided an alternative time so they know I understand that they have other priorities in their schedule.  The way I phrased it, no response nets a call at 10am.  If I said, “Should I call at 10 or 2?” and they did not respond I would have been stuck with a cold call.  One other benefit of this approach method is that if they are the wrong contact person, they typically write back immediately and let you know right away, which saves a lot of time playing tag.

During your first phone call be sure to ask what method of contact works best.  I personally LOVE talking on the phone and I always follow-up with an email summarizing the conversation for a contact report.  However, I do understand that exclusively email or even texting is preferred by some coordinators and I accommodate them.

III - Determine the Decision Makers

Who has the power of the purse strings?

When CROs, EDC providers, recruitment vendors, lab and imaging vendors, or any other type of outsourcing partner approach a new client, they should determine as early as possible who the decision makers are so they are pitching to the right person; get those people in the room during demos and discussions.  On the panel, we all agreed that it is important to navigate the layers within an organization to figure out who signs the contract at the end of the day.  Are there folks that need to be won over in legal and contracts in addition to clinical?  Many organizations have preferred provider relationships and master service agreements, which represent a barrier for new vendors coming in.  Most sponsor companies will require a quality assurance visit or a business assessment before inking a contract with a new vendor.  If the vendor can ask the right questions early in the process, they should be able to define expectations around the proposal process in regards to how long it takes and who needs to bless vendor selection and contracts.

As site monitors, we can also benefit by figuring out who is running the show.  It should come as no surprise that at many sites, the decision of who gets recruited for your trial (or whether your data is entered into EDC in a timely fashion) is often times up to the coordinator.  It really depends on the therapeutic area and how niche the disease state is, but for many studies, it is the coordinator who digs through the patient database and approaches prospective patients with the informed consent.  The manner in which the coordinator presents the trial will impact how appealing the study is to a patient and their caregivers.  You should test this assumption and find out if the key to your enrollment may in fact lay with your coordinator.  Just ask what process they used in the last trial to identify potential subjects.  Try chocolate – it helps.  Make sure the coordinator is behind your study and likes working with you.  The next step is to figure out how to motivate the people whose efforts will contribute to the study goals and milestones.

It never hurts to show up with chocolate.

Moving Forward
OK, and this is a little bit off topic, but what about follow-up after the approach? Whether your first meeting was the start of a beautiful relationship and butterflies/rainbows/lilies rose up around you or whether they slammed the door in your face and you were standing in the cold, you will hopefully be working together and want to grow the relationship.  Consider sending a handwritten thank you card or small gift.  Email a link to an article that might interest them or share a case study or industry tool or website (The Lead CRA blog?) that you have found helpful in a past study.  Stay on their radar without being intrusive and your relationship will grow stronger.   I’m enthusiastic about working on clinical trials and I love building new relationships.  I hope you found some of these tips useful and you can improve your approach when meeting new colleagues in this industry.  Share your perspective with me at theleadcra@yahoo.com or please comment here on the blog.

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

• Improved Investigator and Site Relationships January 2013
• Meeting with a PI August 2011
• Motivating your Coordinators February 2011
• Selecting Qualified Investigators April 2010

Related Content from The Clinical Operations Toolkit blog:

• Worthwhile Webinars May 2013
• Powerpoint Presenter View June 2013
• Change of Seasons June 2013

Tips for Better Monitoring Visits

These are four tips for great monitoring visits.  It all comes back to developing solid relationships as a site manager so you will have access, cooperation, and enjoy more productivity during your time on site.

1. Effective Communication Between Visits

Maybe your coordinators truly are
time-strapped or maybe they just
need a little cheerleading. 

Great communicators know that strong relationships are built on 2 parts listening/respecting and 1 part actively addressing concerns and providing solutions.   Follow-up with your sites weekly to track enrollment, discuss supplies, answer questions, and track EDC completion.  If things aren't trending consistently with your other sites work to uncover the root cause.  During your calls remind the staff of important study updates, upcoming data deadlines, or recent correspondence.  This is especially important with complex protocols.  Keep the check-ins positive, praise often, and be respectful of your site's time.  Communication is a two-way street and hopefully your sites will be comfortable to reach out to you as well.  If you are providing value to your site, they will be more likely to call you when they have questions or concerns rather than proceeding to make errors in execution that you may not discover until your next visit.

2. Assess Site Skill Level
The worst thing you can do is show up to a site and tell them how to run the study.  Don't discount the experience of the investigator/staff. When you go in like a hall-monitor and immediately criticize their process, they will stop listening, become defensive, and you will not be able to compel them to review or revise. First see and appreciate how they are organized, what source are they using, where are they losing efficiencies, and where could they be more precise.  Your first visit should be more than 75% observation and checking things out and less than 25% training unless they are asking for more.  Remember that you can train after the visit during your follow-up phone contacts.  You will need to tailor your site management approach depending on the experience and comfort level of your site.

3. Prepare for the Visit
From your home office or at least a week in advance of your monitoring visit, read the past report, review that pending action items are resolved, and ensure your study coordinator and other relevant site staff will have adequate time for the visit (if not, consider rescheduling). Know the enrollment rate for this site and other sites in the trial.  Compare the performance of this site with other sites and review all the EDC queries and responses since your last visit.  Communicate the agenda prior to the visit.  If you prepare properly for the visit, you'll reduce the risk of a non-productive visit and also be ready to handle any surprises you might discover on-site.

4. Demonstrate Flexibility
Sure you have an agenda and you can't possibly leave the site for the airport until you've achieved all of your objectives, but be willing to shift your day around to accommodate your busy coordinator.  You can perform your monitoring tasks in a different order if that helps the coordinator get organized and juggle your visit while still attending to other priorities.  Agree to do drug accountability while your coordinator wraps up a few outstanding queries in a patient chart.  Agree to meet with the PI at mid-day since they have clinic visits all morning.  The staff at the site will appreciate your flexibility.


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

• Motivating Your Study Coordinators February 2011
• What is up with this coordinator? November 2010
• Routine Monitoring Visits March 2008

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

Motivating your Study Coordinators

As monitors, we rely on the Study Coordinators (SC) to assist us in site management activities like record-keeping and re-supply.  We ask them to keep us informed of progress at the study site through reporting, screening/enrollment logs, issue identification, etc.  We have them prepare the CRFs, complete data-entry, attend trainings, review newsletters/correspondence/memos, answer emails, fax in documents, and answer queries.  On top of everything else, we insist that they organize and prepare for our monitoring visits.  During the monitoring visits, we request that they are available to resolve any issues that are identified or to complete additional training.  This ongoing administrative burden during study conduct is all in addition to the primary requirements that they assist the Principal Investigator in executing the study according to the protocol and monitor the safety of all study participants.

In short, we ask a lot.  Many coordinators have several studies competing for their time and attention and one of the most important skills for a CRA is to motivate the SC to focus and respond to the demands of the trial at hand.  For the most part, my coordinators are prepared for my visits; I owe that to a mix of luck, experience, and the following techniques:

Establish and Maintain Rapport - Whether you meet your coordinator for the first time at an Investigator's Meeting or a pre-study or initiation visit, every interaction is a chance to build the relationship.  Answer your voicemails and emails promptly and invite your coordinators to reach out to you with their concerns. If you can listen and empathize, your coordinator will trust you more and keep you informed if they are falling behind.  If your coordinator feels respected and valued they will put in the time to get the work done properly.

Communicate the Timelines and Study Status - Share the study progress through regular site contacts or a newsletter and ensure that study staff know the timelines and overall picture of the trial.  Review site performance regularly and let coordinators and investigators know how they are doing compared to other sites.  You can set goals and make comparisons in terms of recruitment, enrollment, data entry/query resolution, and monitoring completion; sites find this extremely motivating if you can deliver the message and metrics in a non-confrontational way.  SCs are juggling so many competing priorities that they may not be working on something you need just because they don't realize it is "on fire" at the moment, that is way regular site contact and effective communication is so important.

Recognize Good Performance - When your site completes a required task or important milestone let them know you appreciate this and thank them for their contributions. I am constantly complimenting my sites; they are not perfect but they do lots of things well and I think they deserve that recognition.  I produce a monthly newsletter and I try to include a regular "Site Profile" section where I introduce the site, highlight their study accomplishments, and discuss their tips for success. It is a bit corny but my sites are always flattered and this seems to produce great results.

Don't be afraid to submit to bribery.

Understand and adhere to your company's

policy on gifts. Typically a non-material

small appropriate token such as a box of

donuts or pastries will do a lot to "butter-up"

and endear you to your coordinator

without the risk of appearing coercive.

Partner with your Coordinator - Convince your coordinator that you are a team and that you want them to be successful, "I know you have a lot on your plate, so let's get through this so I can get out of your hair."  Ask your coordinator, "What are the obstacles preventing you from getting your work done? Would you find it helpful if the sponsor, the Project Leader, or I spoke to the PI?"


Break out the Big Guns - All of the techniques I mentioned above will keep your study sites on track and foster a productive and collaborative working relationship.  At the end of the day however, if the work just isn't getting done you may explore alternative less positive methods of motivation.  Expose the deficiencies to the Principal Investigator or withhold site payments pending completion of the work.


Above All, Be Patient - See a related post where I discuss how issues outside of work can sometimes distract coordinators: What is up with this coordinator?

Please comment to let me know if there are other tips or techniques I should highlight in regards to motivating study coordinators.

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

• Tips for Better Monitoring Visits March 2012
• What is up with this coordinator? November 2010
• Routine Monitoring Visits March 2008

What is up with this coordinator?

In a separate post I provide you tips and advice for motivating and working well with your coordinators.  However, sometimes it is hard to get a Study Coordinator to answer the phone, email, or query requests.  Other times they are behind on their Screening/Enrollment logs, supply requests, data entry, etc.  As a CRA Site Manager, this can adversely affect your metrics, status reports, or sense of general management for the site.  If the coordinator is a repeat offender or a general flake you will have to escalate the issue to the Principal Investigator and if necessary to the sponsor; enrollment or study payments may be held until the situation is rectified or the site may be closed.

However, nine times out of ten, I have found that lack of communication or poor performance from the site to be isolated and due to some temporary interruption/issue thereby calling for extra understanding on my part.  You never know what they have going on outside of work. For example, one time my SC was dealing with the recent suicide of his ex-wife and having to care for a new baby so all the work was slipping.  They may have recently lost a sibling, parent, friend, child, etc. and that can affect their work.  I had another coordinator who took a month off work to study for her medical licenses.  One coordinator frequently fell asleep at her desk due to uncontrolled narcolepsy.  The list of distractions/personal issues goes on and on and sometimes their workload is truly too high.

You catch more flies with honey... Bee prepared.
Never assume you have the whole picture.  Show
compassion and find out what is going on
with your coordinator.  This will make great
in-roads towards a healthy and productive
 professional working relationship.

I have always felt more compassion and understanding once I learned what was going on.  It is important not to let the situation spiral too far by keeping a pulse on your site's activities and to strike up a dialogue the moment the work starts to slip or unusual patterns/delinquencies start to emerge.  If your coordinator isn't producing or available, pin them down and ask what the issue is and whether there is anything you can do to help. They don't have to give you all the details in order for you to help them come up with solutions to get the work done.  Coordinators are pulled in many directions but you always need to pay attention and work with them to achieve the study goals.  So the take away is to be as patient as possible with your coordinator. When you are frustrated with a coordinator who is falling short, always stop to ask, "What is up with this coordinator?" so you can be pro-active, problem solve, and best maintain the relationship with the site.

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

• Motivating Your Study Coordinators February 2011
• Investigative Site Recruitment Plan September 2010
• Routine Monitoring Visits March 2008

Traveling with your Boss

So I am working on a new trial and I’ve been on 10+ trips in the last month accompanying my boss.  We’ve been traveling domestically and initiating our study sites.  I’ve enjoyed getting to know my boss outside of the office and we’ve had some memorable trips and met up with some excellent clinical staff and Principal Investigators.  I was not terribly nervous to go on the road with my boss but I did spend a little time thinking about how to prepare for each trip so we would have the best travel experience possible.  Here are some things that I considered when preparing for and completing my trips.

Be on time

Obviously don’t miss your flight but also if it is an overnight trip then get to the appointed meeting place early.  If you are in a rush or flustered you aren’t going to look your best in front of your boss.  It is rude to be late to the study site; don’t let this happen. 

Pack properly

You will feel more at ease if you are organized and prepared.  You want a small bag, not a huge clumsy suitcase.  When you go through security at the airport you want to look like a pro.  Have your baggy of liquids and your laptop easily accessible so you can run them through the scanner. Don’t forget your laptop power supply and phone charger.  Here are a few other must-haves to pack in your carry on:

• Travel confirmations
• printed directions to the hotel and to the site
• GPS (program the hotel and site in before your trip)
• phone numbers for study site and home office
• have cash (this saved me and avoided an awkward situation on a $65 cab fare when the credit card machine was broken)

Dress well

Wear smart shoes that you can easily slip on and off at airport security.  Ensure that your outfit doesn’t inhibit you at the airport or the site (painful shoes, improperly hemmed pants, etc).  Be comfortable and dress appropriately. 

Stay busy and productive

More specifically, stay busy doing something work related (no, not solitaire).  For example, on the plane my boss dozed while I studied the Investigator Brochure, listened to podcasts about the therapeutic area, updated forms, edited the Site Initiation slide deck, reviewed Informed Consent Form templates, etc.  I suspect my boss found this more professional than if I were reading Us Weekly or watching sitcoms on my laptop. When we landed I checked my email and made quick site contact calls as we rode the shuttle bus.

Behave

At dinner you will need to limit the drinks, choose topics of conversation that are light and pleasant, and keep the jokes tasteful. Don't bad mouth previous employers or co-workers. Your boss can dish on anyone they want but you should be very careful to avoid gossiping.  You can be human and talk about kids, dogs, sports, etc, but if something is off-limits to discuss in the office assume it is not the best topic on the business trip, either.

A single glass of sangria may be acceptable but a pitcher of sangria is probably a no no in front of the big boss.

Don’t stress out

I was going to say relax but I want to be clear that you are being evaluated.  Your boss is going to observe your behavior on the trip and you need to remain professional even if the days run long.  You can still be happy and have fun but remember to stay poised.  

Traveling with your boss is a great opportunity.  Prepare for your trip and pay attention to your behavior on the trip.  If you make an error, correct it and don’t repeat the mistake. Your boss isn’t expecting perfection but will absolutely notice if you are disorganized, improvident, or obnoxious.  Have a great trip!

Check out one of my favorite blogs, Road Warriorette's take on this same topic: Traveling with your Boss



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

• How to Break in to the Industry January 2009
• Challenges to a New CRA May 2009
• Business Travel Safety December 2007

Lead CRA Q&A: Investigative Site Recruitment Plan

Mumbabe said...

I am a CRA stationed in the Netherlands. I have done a lot of Pre study site visits and I was wondering how do you ask potential investigators about the number of patients they are able to recruit? Which open ended phrases do you use? Here in NL it is really a big problem as most of the data managers have to go to their database to get such info and that takes them months.

NadiaBoBadia responds...

Don't roll the dice when it comes to
subject recruitment. Asking targeted questions
will help the  PI or Site Director to better predict
how many subjects they will screen/enroll. 

Investigators can usually tell you whether they will be recruiting primarily from their own patient database, advertising (remember all adverts need to receive prior approval from the sponsor AND IRB/Ethics Committee), or whether they will be sending Dear Physician letters to their known and trusted colleagues in the area.  Ask if they will be using one or a combination of these methods.  You could also bring this up in the context of a budget discussion, "Hey Dr. Jones, you will be paid $300 for each SF but up to $3000 for every subject that completes. How many subjects do you expect your site to contribute?"

Hopefully you will be blessed with enthusiastic sites and they will meet their projections but this is not normally the case. Remember, as the CRA, you are qualifying this site (please see a related post: Selecting Qualified Investigators) so thank them for their enthusiasm but be wary of high projections that are not in line with other sites. Be sure to ask them if they see any barriers to recruitment via protocol design (inc/exc too tight, prohibited con meds will make things difficult) or facility shortcomings (no freezer to hold DNA samples, staff shortage, 5 competing protocols, etc.).

Depending on the protocol, you as a CRA can have a direct impact on the recruitment. Call the site often and check in. Refer to a relevant article that discusses motivating your study coordinators. Also make sure they are adequately supplied and that they are looking at every patient who comes through the door as a potential research subject. MDs have many competing priorities, remind them to keep the study on their radar.

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.




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

• Motivating Your Study Coordinators February 2011
• What is up with this coordinator? November 2010
• Pre-Study Visits January 2008

Rental Car Battery Died

This week Hertz rented me a Nissan Maxima.  Like so many of the new rental cars, the key is just a fob and the ignition is just a push button (you hold down the brake and you push a button on the dash that says 'start').  When they handed me the key they asked "Do you know how to turn it on?" and I said, "Oh, one of those, of course.  They are just so nifty until the battery dies in the key fob, then they are not so cool."  In Denver some time ago I went out to the car and the little fob had a dead battery so I had to take the key apart to manually open the door and I found it to be pretty frustrating and unintuitive at the time.

Well wouldn't you know that one evening this week I returned to the rental car after dinner out and the dash was all lit up saying "no key".  I looked at the key I had tossed into the cup holder and thought, "hmmm, well that certainly isn't true."  So I got out of the car.   Locked the doors.  Walked away about 20 yards and then re-approached the vehicle and tried again.  "No key"  I tried holding down the brake and pushing the start button and nothing happened so I began to worry that I was stranded.  Then I noticed that the little red battery icon on the left was lit up and finally the dash just went dark.  I see.  So I figured that the battery of the actual car (rather than the key) was dead; I was surprised the dome light and some dash lights were still illuminated.  Having had the distinct pleasure of renting an inadequately maintained Hertz vehicle in the past I knew exactly what to do and I thought I would share this with you all so you can be prepared if you are ever in a similar situation.

Even in daylight, you need to make sure
you are safe when you approach your
car, especially in a garage.

First I looked out the windows to make sure that no weirdos or transients had approached the vehicle or were lurking around in the parking lot.  Once I determined the area looked secure I grabbed my briefcase and returned to the restaurant bar.  I felt safe in the restaurant but sitting alone in a dead car in the dark waiting for a tow truck is decidedly not prudent.  I always carry the rental agreement in my purse (specifically for this reason) and I have Hertz roadside assistance programmed into my cell phone.  From the restaurant I was easily able to call roadside assistance and provide the address of the disabled vehicle.  I was told I would need to wait up to an hour and I explained that I was willing to wait no more than 45 minutes.  The operator stated that I would be reimbursed up to $50 for a cab and I could go to any Hertz to obtain a replacement vehicle.  I had taken a map from the airport rental location and I noted that there were three other locations near my downtown location.  I rang each one but they were closed so I called the airport location.  I told them to come pick me up and bring me a new car but it was late and the Hertz guy explained he was working alone.  He told me to take a taxi to the airport or wait for the tow.

I felt safe (although inconvenienced) so I waited for the tow truck.  The tow truck easily used his built in jump pack to start the rental car.  He told me the battery would need to be replaced and I should switch out the car.  I gave him $10 tip and he said, "Oh wow, thanks, follow-me to the airport!"  So it seems maybe you aren't supposed to tip but an escort to the airport (about a 30 minute drive) was pretty cool.  The guy at the airport apologized, told me not to worry about the fact that I returned the car only half full of gas, upgraded me to a new car, and I was back in the hotel and in bed before midnight but it was a long night.

So the take aways here are: 1) Do not ask strangers for help under any circumstances 2) be aware of your surroundings 3) immediately get yourself out of a compromised situation and go somewhere safe 4) be patient, to a point 5) Do not ask strangers for help.  OK, so number 1 and number 5 are the same but it is just that important.  All the major rental car companies have roadside assistance and if you try to mess around with jumper cables or fix the car yourself you will not be paying attention to what is going on around you plus you may damage the car.  Limit your liability and use the existing process to mitigate your personal risk.  Next time you rent a car keep the contract on your person and also program the roadside assistance number into your cell.  Happy travels!

Employment Reference

One of my colleagues and close friends recently lost her CRA position due to a large round of layoffs at our former employer. I was aghast that she was let go and I felt terrible for the sponsor since we had worked on the same trial here in California; the former team of six was now reduced to just one. The sponsor tried to hire her directly but the CRO refused to allow her access to the clinical trial management system and replaced her with a Junior CRA located on the East coast. I comforted my friend and offered myself as a resource in her job search. I think her work is of the highest caliber and given the opportunity to work with her again, would do so instantly. She has been a great mentor and is truly a talented and dedicated CRA. I contacted all of my trusted recruiters, referred her to my current company, and provided resume and interview advice. Not too long after, a hiring manager contacted me to discuss my friend’s background and experience. I was prepared for the call and gave an excellent reference (if I do say so myself).


Here are the employment reference questions the hiring manager asked me about the person I was referring:

• Describe the employee’s technical and industry skills.
• Is the employee good at resolving problems?
• How does the employee adapt to using new tools/systems?
• Does the employee demonstrate compliance to regulations?
• Have you observed the employee struggle with time and expense reporting policy?
• Describe the employee’s site communication style.
• How does the employee interact with peers?
• What do you think of the employee’s written expression?
• Do you have anything else to add?

So who should you provide as references? The company you are applying for may want to speak with specific people, but typically they will be happy to chat with a supervisor, a peer, and a personal reference. Supervisor doesn’t actually have to mean your current boss (especially if you are trying to keep your job search confidential or you don’t trust your current boss to promote you well enough). You should provide someone with supervisory responsibility for your work. This could be a line manager, dotted line supervisor, or even a project manager who maybe didn’t directly supervise you but was very familiar with your day-to-day performance and responsibilities. Secondly, I like to provide a peer who is at the same level or slightly higher than me in the organization and who has observed my work in the field. For the third reference, I like to pick someone from a different functional group in the organization or a strong personal reference. For example, I might ask someone from legal, accounting, or data management that I have worked closely with or maybe someone from a professional organization like ACRP or someone who I have volunteered for or with outside of the industry to serve as a reference.


How do you ensure your references are prepared? Ask them if they are comfortable being your reference. Pick someone who is responsive and willing because if the hiring manager can’t get in touch with your references, this could interrupt the offer process (trust me, I know from first hand experience). Then, meet them for coffee or schedule a telephone call or short meeting to help them prepare. Provide them a copy of your resume, a copy of the job description you are applying to, and a list of skills and past successes you want them to highlight. Explain to them why you are applying for the chosen position and what special strengths and relevant experience you think you offer. Request that they write up and post a recommendation of your work for LinkedIn or do a practice run with you so you know you are comfortable with what they are saying. Ask your reference to let you know if they are contacted and get feedback on how it went. Genuinely thank your reference afterwards with a hand written note, a meal out, or a small gift or giftcard.


I am happy to report that my friend has been snatched up by a wonderful company; talented people don’t last long in the marketplace. She is enjoying her new assignment and especially pleased about her 15% raise, did I mention she is a great negotiator? Being laid off can be extremely rattling, but if the quality of your work stands on its own, remain positive, reach out to your network, prepare sufficiently for your job search, help your references prepare, and trust that things will work out.

Lead CRA Q&A: Dealing with Poor Performance Feedback

Anonymous said..

I understand the productivity loss, time, costs, etc of choosing an inadequate site; however, what are the ramifications against a CRA who chooses a site that turns into a "dud" site? -APRIL 7, 2010 2:00 PM

NadiaBoBadia responds...


Wow, this is a challenging question.  I only choose great sites that end up as top enrollers and execute the protocol flawlessly so I am completely unqualified to answer - ha!  In all seriousness, I think that in any job or task where you can demonstrate that you performed methodically, deliberately, and intelligently the study team would be hard pressed to fault you in your efforts.  If you build a strong reputation for yourself through quality work and your team trusts you, the backlash from these types of issues will likely be minimized but you still may find yourself "on the hook" for a poor performing site.  During my site selection efforts I keep a log of my activities and communications so I can reflect back on the process 1) to look for potential efficiencies for next time 2) to serve as a training tool for Junior CRAs that I mentor and 3) to demonstrate/remind myself/others that I was diligent and thorough in my original efforts (my colleagues and I lovingly refer to this type of documentation trail as CYA).

If I am called to task on poor performance, I will have some documentation to defend my actions, explain my thinking at the time (hindsight is 20/20), and deflect some of the backlash.  This is a delicate line because you want to explain the history behind errors but you need to be careful not to dwell and beat yourself up too much.  You have to move forward and get recruitment back on track - be proactive and start brainstorming solutions.  Just like we tell our study sites, you acknowledge the issue, you create a plan to avoid the issue in the future (obtain guidance and re-training as appropriate), and you implement that revised process.  So you picked a "dud" site, coach them, encourage them, and try to salvage things if at all possible.  How cool would it be if you worked hard enough and your problem site transformed into a model site?  If all else fails, the study team may elect to close the site and focus efforts into better performers but I hope you have been tracking your site correspondence and have been a good site manager and partner (and can prove it with documentation).


Only an unreasonable employer expects you to perform perfectly at all times.  The best we can train for is to develop a toolkit of monitoring skills and a clin ops intuition for making the best decisions.  At the end of the day, we are human and fallible and need to be able to accept our failures when they do happen (and they will happen, this can be a challenging job).  That said, someone does sometimes need to take a fall and as a CRA you may be grilled or disciplined by the study team.  You may receive poor performance feedback at a review or have an uncomfortable conversation with your supervisor or study team.  In my career,  I have known CRAs who were yanked off of trials or "sacrificed" for political reasons not necessarily performance reasons.  I've witnessed CRAs be unfairly scrutinized or singled out in meeting/telecons for site performance issues that were more or less out of their control.


Having your work or ideas criticized can be humbling and may not be warranted, but it is bound to happen at some point.  I hope for every CRA that negative feedback is always delivered respectfully and constructively.  When your work does not meet your employer's expectations, limit the excuses, graciously accept that feedback, and improve. A mistake can be devastating or it can be a development opportunity.  In other words, you can't undo errors, but you absolutely have complete control over how you react and recover from a mistake.  I keep track of my successes at work in an email folder called 'Praise'.  For example, if I get a note from a peer or a higher up complimenting my work, I file it away for later.  Reviewing the items in the 'Praise' folder is a great pick-me-up when I've had a challenging day or even to share with my supervisor when we are reflecting back on my overall performance at review time.  I've veered a bit off topic but I hope my thoughts on dealing with poor performance feedback are helpful and have addressed your question.


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.



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

• Meeting with a Principal Investigator August 2011
• Work/Life Balance June 2009
• Routine Monitoring Visits March 2008