Clinical Study Admin & Documentation Specialist

Oxford Global Resources; Brussel Hoofdstad; On-site; EUR 37,000 - 52,000; Full time

Benefits offered by this job

Office-based position

Permanent contract

Job summary

Oxford Global Resources in Belgium is seeking a Clinical Study Assistant to provide administrative and operational support to study teams throughout the lifecycle of clinical studies. Presence at the client’s location (north of Brussels) is required.

You will help maintain study documentation, prepare regulatory binders, and support QA, site audits, and study communications. This office-based role offers a permanent contract and a solid entry path in clinical research.

Qualifications

• Bachelor's degree or equivalent relevant qualification.
• A first experience in clinical research.
• Strong organizational and administrative skills with excellent attention to detail.
• Proficiency in Microsoft Office applications.
• Fluent in English; proficiency in an additional European language is considered an asset.
• Existing right to work in Europe required.

Responsibilities

• Create and maintain the Table of Contents for Study Site Regulatory Binders in collaboration with study management.
• Prepare Study Site Regulatory Binders and Patient Binders with approved study documentation.
• Perform quality reviews of site-specific regulatory and patient binders.
• Package and distribute binders to study sites and internal stakeholders.
• Review, file, and maintain study documentation, including site and sponsor correspondence, EC submission packages, and TMF documents.
• Track submissions and correspondence related to essential study documentation.
• Support site audit readiness activities and ensure documentation compliance with study protocols, regulations, and SOPs.
• Act as the primary CTA contact for assigned Business Units; participate in study meetings and discussions.
• Maintain investigational product records for regulated studies and support study communications.
• Track and coordinate shipment of study-related equipment and data between sites, sponsors, and laboratories.
• Provide logistical support for meetings, including scheduling, agendas, teleconference coordination, and meeting minutes.
• Assist with site activation and close-out activities.
• Manage multiple priorities and identify risks to timelines; support workload planning.

Skills

Organizational skills

Attention to detail

Communication

Teamwork

Fluent in English

Additional European language

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

Oxford Global Resources in Belgium is seeking a Clinical Study Assistant to provide administrative and operational support to study teams throughout the lifecycle of clinical studies. Presence at the client’s location (north of Brussels) is required.

You will help maintain study documentation, prepare regulatory binders, and support QA, site audits, and study communications. This office-based role offers a permanent contract and a solid entry path in clinical research.