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Compliance In Focus
Posted by Stephani Hulec on Thu, Aug 27, 2020

How IMARC Hires And Trains Our Monitors

As a global medical device CRO, monitoring has been at the core of our mission at IMARC since the company was founded over 20 years ago.

Monitors-hiring

We take great pride in the fact that not a single one of the sites we've monitored from the beginning has received a warning letter in that time.

The biggest contributing factor to our success is the high standards of quality we have for our team. If you’re considering hiring a monitoring CRO, here’s what sets ours apart.

What Do We Look For When Hiring Monitors?

In an industry where turnover can be as high as 30%, many of our monitors have been with us for years. Some of our most successful hires have been people with prior clinical research experience, though that doesn’t necessarily mean they previously worked as monitors.

Unfortunately, monitors can sometimes develop bad habits that become more deeply ingrained the longer they’re in the field.

For instance, they may not understand the importance of going back to the true source to verify data. Reviewing the patient’s medical record, or where the data was originally documented, is the only way monitors can fulfill their responsibility to ensure data integrity.

We train our monitors to act as detectives, reviewing the medical records first so they can catch discrepancies or uncover information that wasn't originally captured.

For instance, a patient’s medical history may show they are taking medication for diabetes, but there may be no mention of that pre-existing health condition in case report form. We would expect our monitors to see the big picture and identify when something doesn't make sense.

If a monitor rarely finds anything at your sites, that’s a big red flag. They should be digging deeper, spotting inconsistencies and asking follow-up questions.

We look for monitors who are able to think critically and act with confidence to solve the inevitable problems that arise. For instance, if a monitor discovers a patient’s original informed consent document is missing, we need to know that they will handle the situation appropriately, which could mean a variety of things depending on the situation. 

It’s not always easy to evaluate someone’s critical thinking skills on paper, so our process for evaluating monitors is extensive. We have several rounds of interviews and ask many open-ended questions to gain a better understanding of how a candidate would handle these challenges.

How Do We Train New Monitors?

Although the FDA does not require any formal training for monitors, we believe training is an essential part of maintaining consistent compliance across studies. 

Every new IMARC clinical team member receives training in the basics of the Code of Federal Regulations (21CFR). They learn the regulations for electronic records, informed consent, human subject protection, financial disclosures and IRB requirements. They also learn the process for obtaining FDA approval of medical devices and how this regulation differs from obtaining approval for drugs. Additionally, every staff member develops a strong working knowledge of ISO regulations and ICH guidelines, including Good Clinical Practice (GCP.)

Once they have completed our standard onboarding and training, our monitors receive additional training to help them prepare for their specific responsibilities.

That includes training in the different types of site visits, monitoring activities, product accountability and adverse event review. They also learn how to handle situations that aren’t always obvious using our proprietary FAIR Shake™ framework.

Next, our monitors accompany an experienced team member for several monitoring visits. At first, they observe. Then they take increasing responsibility of their visits until finally, they take the lead as their trainer observes them.

This helps them become familiar with the expectations of their role, while also giving them the confidence to be on their own. However, another one of our biggest advantages is that our monitors are never truly alone. They can always consult with the lead clinical research associate, project manager or another team member who is familiar with the study.

We use that same system of checks and balances to ensure all critical information is captured in our monitoring documents clearly. 

How To Get Started With Our Monitoring Services

The right clinical monitors serve an essential role of protecting your study subjects and ensuring compliance.

Our experienced monitors truly become an extension of your team. Rather than just serving as a second set of eyes, they act as an independent consultant who can advise you in best practices and help you find creative solutions.

Our comprehensive monitoring services can support you at every stage in your trial, from site assessments through study close-out visits.

And if your team has decided to perform some activities virtually to protect patients and staff during the COVID-19 pandemic, we can also assist by working with you to complete remote monitoring.

Getting started is as easy as granting us access to a secure file-sharing system or letting us set up one for you.

If you’d like to learn more about our clinical monitoring process and how our team works with yours, schedule a 15-minute consultation today.

Monitoring Services Consult - V2

 

Topics: Clinical Monitoring

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