Site Monitor (FSP) - Poland
Poland, Remote Job ID R0000017236 Category Clinical TrialsAbout this Role
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability.
We are currently looking for a Site Monitor (Clinical Research Associate II) to join our growing FSP Clinical Operations Team in Poland.
Key Accountabilities:
- Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
- Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
- Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required.
- Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
- Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification.
More about you
On your first day we’ll expect you to have:
- Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Ability to perform all clinical monitoring activities independently (on-site and remote)
- Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.
- Strong interpersonal, written, and verbal communication skills within a matrixed team.
- Fluent command of Polish and English.
- Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
- A client-focused approach to work and flexible attitude with respect to assignments/new learning.
- The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
- An honest and ethical work approach to promote the development of life changing treatments for patients.
- Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.
- Ability to manage required travel of up to 75% on a regular basis.
If you are ready to join Parexel’s Journey, please apply!
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