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Senior Clinical Research Associate
2 maanden geleden
About the Role
Parexel is seeking a Senior Clinical Research Associate to join our Clinical Operations Team in the Netherlands. This role can be office-based in Amsterdam or decentralized in the Netherlands.
Key Responsibilities
- Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites and generate visit/contact reports.
- Build relationships with clinical sites and staff, ensuring the integrity of the study and promoting rapport.
- Protect patients by reviewing the performance of the trial at designated sites and ensuring compliance with protocol, GCP, and regulatory requirements.
- Develop patient recruitment strategies in conjunction with clinical sites to meet enrollment timelines, while ensuring compliance with SOPs, protocol/amendments, and regulatory requirements.
- Evaluate the quality and integrity of reported data, site efficacy, and drug accountability.
- Monitor the completeness and quality of Regulatory Documentation and perform site document verification.
Requirements
- Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Ability to perform all clinical monitoring activities independently.
- 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 knowledge of Dutch and English languages.
- Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
- Client-focused approach to work and flexible attitude with respect to assignments/new learning.
- Ability to manage multiple tasks, evaluate unpredictable scenarios, and achieve project timelines.
- Honest and ethical work approach to promote the development of life-changing treatments for patients.
- Strong computer skills, including knowledge of CTMS, EDMS, and MS-Office products.
About Parexel
Parexel is in the business of improving the world's health by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. We believe in our values: Patients First, Quality, Respect, Empowerment, and Accountability.
