Creating company's identity through people

We believe that successful performance is hard to achieve without standardized processes. So many successful businesses are examples of this idea, from fast-foods like McDonald's or Star Bucks, to auto manufacturers like Toyota or Volkswagen. When a traveler comes to another country, the first place to eat that pops in their mind is indeed a McDonald's. Why? Because they have no stress deciding what to eat there, how to order it, they can be sure their hamburger will have controlled ingredients and the chances of developing a diarrhea are miniscule. The reason for that is that all processes are standardized and their implementation is constantly scrutinized.

The same is with hiring a vendor in clinical trials. When a vendor has implemented procedures which are respected and followed, it brings quality within. At the end of the day, you'll be sleeping well at night knowing this.

Showing what you really care about with quality assessment system

This content is in development.

Investing in education of newly identified talents

There are certain stereotypes thriving in Ukrainian CROs and SMOs of the people who should and should not be hired for monitoring jobs. Maybe, these stereotypes are not inherent qualities of Ukraine only, but we won’t speculate. When it comes to hiring, it’s unequivocally the preference to people with large monitoring experience, at least 5 years in a row, and specifically having worked within large international Pharma companies (e.g., Pfizer, MSD, or AstraZeneca) and CROs (e.g., Quintiles, PPD or Icon).

When it comes to people whom the industry is reluctant to hire, there are especially noticeable prejudice against people who have worked in sales, even despite the fact that those were sales of pharmaceutical products within the same industry or even the hiring company.

Herein, we’d like to provide our opinion on these biased practises and suggest a better approach to selecting people for CRA jobs.

First, experience, though can conveniently be expressed in numbers of years, is quite a subjective thing. Some people have come through hardships that made them more prepared for future problem-solving; others have re-lived the same day all over again, basically evolving their personal routine of how not to get in trouble.

Experience is indispensable. Some things can’t be taught in trainings and SOPs. You can read all you want about on-site activities, but until you initiate a talk with the PI about the unfulfilled obligations, missed timelines, violated patients’ safety and unsatisfactory source documents, you don’t know anything about effective monitoring, delivering the study and crucial confrontations. And it’s not just interpersonal skills where experience counts – all problems boil down to the same core issues. Read more…

An experienced monitor with five years of experience has been there and done that. But can you be sure that her previous employer spent enough time and resources to make sure that the monitor is trained enough and aware of applicable regulations. Of course, you can’t! Moreover, there’s a good chance they even didn’t have an initiation training, periodic evaluations and trainings, training logs, GCP re-certification, not to mention IDP and ad-hoc personal development trainings (e.g. for boosting negotiations skills, writing better monitoring reports, learning mailing etiquette, etc.).

Tabula rasa! But there’s even a worse scenario. Imagine, or rather remember, that monitor who is a “Mr. Know-It-All”. You don’t tell him what to do, he knows it better. They will initiate unnecessary mailing with “questions of utter importance”, involving half of your company in re-evaluating your current SOPs and seeking answers that have long been given. After the numerous arguments, there’s a good chance they will switch their opinion leaving people in suspension as to the origins of the discourse.

Or the one type, who has learnt the mantra “Because we always did it this way!” Even more difficult than to learn something is to re-learn it, a skill which is regarded essential for the 21^st century employees. And with “experienced” guys it might be more often the case.

Basically, it’s not only about experience. It’s about a set of skills that are dynamic, re-shapeable, ready for adaptation, if you will. And if there’s a word for describing “the ability to adapt to and grow into increasingly complex roles and environments" – it’s “potential”. Read more…

For the past few decades, employers have focused on competence, breaking down jobs into "competencies" and seeking candidates with the right blend of them, according to Fernández-Aráoz, senior adviser at Egon Zehnder. Competency-based hiring, however, is becoming insufficient in "a volatile, uncertain, complex, and ambiguous environment," he says.

"The question is not whether your company’s employees and leaders have the right skills; it’s whether they have the potential to learn new ones."

“Businesses may focus on hiring someone with eight to 10 years of experience, but sometimes that’s really "one year’s experience times eight."

We developed a multi-step training program for people with different background and experience. People fresh to clinical trials and monitoring should start this program from the very beginning; those with previous monitoring experience can start from the following steps. We ensure that all major topics are covered by all the employed regardless of their background. To make things more “lively” there is a set of tests after each step which learners have to complete in order to proceed to their further education.

The steps are comprised of lectures, workshops and quizzes. While lectures are purely theoretical, this is a major source of information. We intensively use the materials of “TransCelerate” initiative.

After the initial training program, newcomers must perform at least three training site visits accompanied by more experienced colleagues (line managers). Before the visits, there’s a preparation procedure. A monitor working with the site informs the line manager and the freshman about the current state of affairs — pending issues to check, plan of activities for the visit, desired outcomes from the visit.

On site, the trainee gets to do his part of work in a safe supportive environment. A very important part of educational visits is discussion of monitoring results with investigators of the site. By looking and listening, the trainee absorbs the style of work from his colleagues.

During the next few days, the monitor completes a monitoring visit report and the freshman is asked to complete his version of a report. All three participants gather again and discuss their reports with focus on corrective and preventive actions (CAPA).

This type of activity has to be completed for each type of visits, e.g. site qualification visits, initiation visits, monitoring visits, close-out visits.

After several educational visits, a newcomer gets the chance to monitor himself. But first, several visits are accompanied by a designated line manager. And only after that, we have a trained CRA I.