Cindy Venendaal, PhD, MPH, CCRA

Global Project Director

The communication flow should be seamless to ensure that the client has all available information at their fingertips.

A day in my life at Clinipace

Currently, I am the global project director for two large, international Phase III non-small cell lung cancer trials. I begin my work day by creating a "to do" list and prioritizing tasks that need to be accomplished. Communication is critical when working with an international study team, so I spend the majority of my time interacting with our study teams around the world in Latin America, Australia, Asia and Europe. We discuss regulatory requirements, informed consents, tissue banking, safety reporting, contracts and budgets, monitoring, enrollment, study timelines and other operational items on a daily basis. I also speak directly with the sponsor frequently to provide them with updates on the progress of the study.

 

My "a-ha!" moment

If you're lucky, you will have a moment (or more) in your career when one of your projects reminds you exactly why you do what you do every day. I have experienced a few of these moments over recent years. I was working on a rheumatoid arthritis study where I had the opportunity to meet one of the patients the day he was being enrolled. This patient was in a significant amount of pain and daily life activities were a challenge. I saw this patient again about a month later and the improvement was impressive. The patient was able to move around with less pain and their mood was completely different. I have also worked on several oncology studies and it is memorable when you review a patient chart from the beginning of the trial to the end of the trial and the progress notes indicate an improved quality of life or exceeded life expectancy. That is when you realize that you have helped to make a difference in someone's life.

 

The most important consideration a client should take when undertaking a clinical research project

It's important to know that the project management team at a smaller CRO is likely one of the most experienced teams a client could hire. They are able to hand pick employees and tend to hire only people with a proven track record in the industry. The client is also more likely to have the same project team throughout the entire trial when working with a smaller CRO.

 

One of the biggest misconceptions I run up against in my daily duties is

Some clients don't realize that the project director should be viewed as an extension of their study team. The communication flow should be seamless to ensure that the client has all available information at their fingertips. As the study progresses, we will also proactively identify any potential concerns and have a plan of action. Also, as a project director, all of the information from the study team is funneled through me and then to the client. However, it is important for the client to know that they are always welcome to contact any of the team members directly, as needed. Our goal is simply to ensure that the client is always kept up to date.

 

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