Senior Clinical Research Associate
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Our client, a leading player in the MedTech industry, is seeking a Senior Clinical Research Associate to manage clinical study activities across multiple sites. This role focuses on overseeing study site performance, conducting comprehensive monitoring visits, and ensuring high-quality data collection for various medical device projects.
Responsibilities
- Manage clinical study activities and site performance for multiple projects according to overall project timelines.
- Conduct site visits, monitoring, and communication to ensure compliance with study protocols and regulatory requirements.
- Oversee the maintenance of Investigator Site Files and ensure the safety and well-being of study subjects are maintained.
- Support patient recruitment and retention activities while resolving site-level issues through corrective and preventive actions.
- Execute clinical trials in alignment with established standard operating procedures, GCP, and relevant regulatory standards.
- Collaborate with investigators, IRBs/ECs, and vendors to support the implementation of new clinical systems and processes.
Requirements
- You have a Bachelor degree in Life Sciences, Nursing, or a related field.
- You have 4+ years of recent experience in site monitoring within clinical research, specifically for medical devices.
- You possess a strong understanding of GCP and regulatory standards applied to medical devices and combination products.
- You bring experience working with computer systems including Microsoft Office (Excel, Word, and PowerPoint).
- You're characterized by leadership abilities and strong organizational skills to manage multiple tasks and deadlines simultaneously.
- You are willing to travel up to 80% of the time to support site visits and clinical activities.
- You are fluent in English and Dutch with the ability to converse and review medical documentation.
Nice to Haves
- Industry certifications such as CCRA, RAC, or CDE.
- Clinical or medical background.
- Working knowledge of French.
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