Joanna is our Global Operational Compliance Manager. She has been working within the Clinical Research industry since 2013.
Joanna has a master’s in Biomedical Engineering. Right from the start, she wanted to use acquired knowledge to work with groundbreaking projects that can help the whole population of Patients. Joanna’s career path led her to the clinical trial industry and great people that share the same value – fighting for the better future of Patients. For her, it is essential to remember why we are doing everyday work and that cooperation and knowledge-sharing in this industry are everything.
Let’s see what she had to say when we finally sat down with her in the late evening on a Teams call with some hot tea.
Define yourself: One word
Joanna: Active
What is your Mission in Clinical Trials?
Joanna: My mission is to help develop breakthrough therapies and ensure that clinical trials are conducted in accordance with GCP standards, industry standards, and legal regulations.
In a word, how would you describe your career in Clinical Trials?
Joanna: Journey
Women in Clinical Trials are …
Joanna: Great Professionals
What makes you happy working in Clinical Trials?
Joanna: It makes me happy to see how the current medical knowledge evolves and the purpose of our work – exploring new safe and efficient therapies that give hope for Patients.
What makes your job at Pratia exciting?
Joanna: Working at Pratia is exciting. This is the place where science and medicine meet. You can see how the clinical trials are perceived from the Patient, Doctor, and Sponsor’s perspective. It is essential to see all of these perspectives – all of them are equally important for the industry to cooperate and work together toward medicine evolution and improvement. I work at Pratia because here, I feel that my work matters.
Imagine you are the Pratia superhero: How do you solve the challenges and needs of your colleagues and Clients?
Joanna: If I were a superhero with superpowers, my first action would be to provide reliable information about clinical trials and healthcare to every Patient on Earth.
Unfortunately, you can see a lot of disinformation in social media regarding clinical trials, healthcare, and the treatment of diseases. Some Patients have limited ability to access proper medical consultation. These reasons cause that chance to receive appropriate medical care is decreasing for some Patient populations. The disease is already significantly advanced when the Patient comes to the Doctor for the first time, so the prognosis is worse than it could be if the Patient had access to accurate information about medical options.
It is the biggest challenge for the whole industry – be on time with the efficient treatment for the Patient – and you can significantly increase the chances if Patients are well informed about the medical options, clinical trials, and diagnostic tests.
Why is it important to participate in Clinical Trials? Why are Clinical Trials important in the evolution of medicine?
Joanna: We could talk a lot here about the drug approval process, but the essential key message is that: without clinical trials, we would not have any innovative therapies or new drugs.
To assess the safety and efficacy profile of the new drug, they need to be studied in the human population. Of course, studies in the human population are a very advanced phase of drug development – before the clinical trials in the human population, the new drug must undergo a lot of laboratory and pre-clinical studies. Only if these laboratory and pre-clinical studies are successful and satisfactory results are achieved is it possible to start clinical trials for healthy volunteers and Patients. And there is a lot of legal and medical safety measures within Clinical Trials that help safeguard the Study Participant’s health and well-being.
People say that nobody controls Doctors in CT? It’s a myth. What do you say to these people to change this perception?
Joanna: Indeed, it is a myth. First of all – to start the Clinical Trial, you need to have proper formal approval from the Regulatory Authority and Ethics Committee. Every Principal Investigator – a Doctor who is conducting the trial – is thoroughly checked if he or she has the proper knowledge, experience, and training to conduct the trial.
Second – Investigator needs to strictly follow the Clinical Trial Protocol that Regulatory Authority and Ethics Committee approved. This means that medical procedures are clearly described, and Investigator cannot deviate from them. The Investigator’s adherence to the protocol procedures, GCP standards, and legal regulations is regularly checked by CRA – a designated person by the Study Sponsor. CRA is verifying all of the procedures that were performed within the Clinical Trial at Investigator’s Research Site – this is called a monitoring visit. In addition to the monitoring visit, independent audits are organized to check if Investigator is conducting the trial according to protocol, GCP standards, and legal regulations.
Finally – Investigator can also be inspected by the regulatory authority – FDA, EMA, or local Regulatory Institution.
What is your message to women thinking about starting their career in Clinical Trials?
Joanna: Definitely – go for it. It is a fascinating, buoyant industry – full of hope for a better future for human life. Working in the Clinical Research industry, you can feel that Teamwork and supporting each other are essential to achieving ambitious goals.
Did you know that?
After graduation in Biomedical Engineering, Joanna’s career path began in the clinical research operations field at a Clinical Research Site. During this time, as a part of the Study Team, she gathered wide experience with different therapeutic areas and study designs, underwent multiple client audits and inspections, and in 2019 was awarded 2nd place in National Contest “Leaders in Clinical Trials.”
To further expand her knowledge, Joanna has undergone postgrad studies in Healthcare management, Clinical Trial management, and Quality management. With progress to local and subsequently global compliance areas, her Team’s goal is to create and maintain a client-oriented, employee-engaging, efficient and effective Quality Management System. Joanna is a Certified Internal Auditor and Management Representative (Integrated Management Systems).
Apart from work, Joanna is a member of the ACRP and RQA society, she holds professional certification (ACRP-CP), and actively works in the Quality Assurance group of GCPpl society. Privately, she plays violin and climbs mountains.
85% of employees at Pratia are Women. We genuinely believe that Women in Clinical Trials play a vital role in the future of medicine. Our mission is to promote gender equality and continue developing a work environment where we celebrate and encourage the talent and achievements of our colleagues.
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