Senior CRA (Netherlands) — Remote & Travel-Ready

Alimentiv; Amsterdam; On-site; EUR 65,000 - 85,000; Full time

Job summary

Alimentiv is seeking an experienced Senior CRA to independently perform, coordinate, and oversee all aspects of clinical site monitoring services in line with ICH-GCP and sponsor SOPs. The role acts as the primary liaison with investigative sites and mentors CRA I & II while ensuring protocol adherence and regulatory compliance.

Travel is required (up to 40-60%), with home-based work options. The candidate should have 4–9 years of related experience, a Bachelor's (Honors) degree, and Fluent

Qualifications

• 4 - 6 years of related experience.
• 7 – 9 years of related experience.
• Bachelor’s degree (Honors) required.
• Master’s degree preferred.
• Fluent in written and verbal English.

Responsibilities

• Independently conduct and document onsite and remote site monitoring and close-out visits.
• Review data for consistency with source documents and study requirements.
• Resolve data queries and escalate issues as appropriate.
• Coordinate shipment of clinical supplies and study documents.
• Ensure site staff are trained on protocol, study plans, ICH-GCP.
• Participate in progress meetings and Investigator’s meetings.
• Review ISF/TMF for accuracy, timeliness, and completeness; request documents as required.
• Act as primary contact for investigational sites and oversee study integrity.
• Support site access to study systems and ensure training compliance.
• Address site-related issues to resolution and manage deviations.
• Coordinate project-wide communications to provide ongoing data and updates.
• Identify and advise on site investigator selection and activation.
• Support start-up by following up on pending documents; translate site documents as required.
• Assist regulatory localization and translation of site documents.
• Help optimize patient recruitment and meet milestones.
• Mentor CRA I & II; participate in CRA interviews.
• Participate in process improvement initiatives and best practices.
• Perform CRA Assessment Visits and co-monitoring visits.

Skills

Communication

Organizational skills

Problem-solving

Attention to detail

Driver's license

Education

Bachelor's degree

Master's degree

Tools

Medidata Rave

Oracle InForm

IRT

eTMF

CTMS

Microsoft Office

Job description

Alimentiv is seeking an experienced Senior CRA to independently perform, coordinate, and oversee all aspects of clinical site monitoring services in line with ICH-GCP and sponsor SOPs. The role acts as the primary liaison with investigative sites and mentors CRA I & II while ensuring protocol adherence and regulatory compliance.

Travel is required (up to 40-60%), with home-based work options. The candidate should have 4–9 years of related experience, a Bachelor's (Honors) degree, and Fluent