Site Monitor (FSP) - Netherlands
Netherlands, Remote Job ID R0000017235 Category Clinical TrialsAbout this Role
We are currently looking for a Site Monitor (Clinical Research Associate II) to join our growing FSP Clinical Operations Teamin the Netherlands.
You would be dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases. Our sponsor has a long history of excellence in research, delivering medicines, vaccines, and other health solutions for some of the most difficult diseases in the world.
What you’ll do
- Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
- 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.
- Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
- 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.
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 a life science, nursing qualification or other relevant experience required.
- Strong interpersonal, written, and verbal communication skills in 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).
- Fluent command of Duch and English is a must.
- 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 impact, flexibility, and career development appeal to you, Parexel could be your next home.
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