Senior Clinical Research Associate

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Act as the primary point of communication with project stakeholders.

• Ensure adherence to timelines, objectives, and standards for clinical research projects.

• Establish and nurture relationships with clinical sites and investigators.

• Prioritize the rights, safety, well-being of subjects, and compliance with data quality standards.

• Execute and document various onsite monitoring visits.

• Lead the study startup phase effectively.

• Conduct reviews of Case Report Forms (CRFs), perform source document verification, and resolve queries.

• Oversee communication and activities at each site.

• Manage site activities, timelines, and schedules efficiently.

• Serve as a contact point for in-house support services and vendors.

• Assist in quality control efforts, including compliance monitoring and report assessments.

• Engage in feasibility research initiatives.

• Aid the regulatory team in preparing documentation for study submissions and obtaining regulatory approvals.

• Help enhance PSI's presence in the Netherlands.

• Collaborate closely with colleagues throughout the broader organization.

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences (or a related field), or a comparable combination of education, training, and experience.

• Experience in independent on-site monitoring within the Netherlands.

• Proven experience in all types of monitoring visits during Phase II and/or III studies.

• Excellent written and verbal communication abilities.

• Proficiency in Dutch and English.

• Advanced skills in MS Office applications.

• Possession of a full and clean driver's license, along with the willingness to travel.

• Strong communication, collaboration, and problem-solving capabilities.

• Capacity to multitask and thrive in a dynamic team setting.

• Experience in supporting Oncology studies is a plus, though not mandatory.

🏝️ Benefits

• Opportunities for professional development and career advancement.

• Commitment to investing in employees’ professional growth and success.

• Flexible remote/home-based work arrangements.