Senior Clinical Research Associate

BeBee

Academy & AI Juridisch Profiel Nederland - Senior Clinical Research Associate Healthcare PSI CRO Vandaag Tot 29-3-2027 Voltijd Volledig remote

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Functieomschrijving

PSI is a leading Contract Research Organisation with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects' rights, safety and well-being and quality of data compliance.

This is a home-based position. Your responsibilities will include

• Conducting and reporting all types of onsite monitoring visits
• Driving the study startup phase
• Performing CRF reviews, source document verification and query resolution
• Be responsible for site communication and management
• Supervising study activities, timelines, and schedules for each site
• Acting as a point of contact for in-house support services and vendors
• Supporting quality control, such as compliance monitoring and reports review
• Participating in feasibility research
• Supporting the regulatory team in preparing documents for study submissions and regulatory approval

Qualifications

• BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in the Netherlands
• Demonstrable experience in all types of monitoring visits in Phase II and/or III
• Strong written and verbal communication skills
• Fluency in Dutch and English
• Experience supporting Oncology studies is beneficial, but not essen...