Clinical Study Assistant

Oxford Global Resources; Brussel; On-site; EUR 40,000 - 50,000; Full time

Benefits offered by this job

Permanent contract

Office-based position

Job summary

Oxford Global Resources in Belgium (Brussels area) is seeking a Clinical Study Assistant to provide administrative and operational support across study lifecycles. The role emphasizes document management, regulatory binders, and coordination with study teams to maintain compliance and audit readiness.

You will handle study materials, support site activation, and ensure timely communication with stakeholders, contributing to quality assurance in clinical research.

Qualifications

• Bachelor's degree or equivalent.
• First experience in clinical research is required.
• Strong organizational and administrative skills with excellent attention to detail.
• Proficiency in Microsoft Office applications.

Responsibilities

• Study Document Management: Create and maintain binders, collate study documentation.
• Document Control & Quality Assurance: Review and file TMF and EC submission packages; ensure compliance.
• Study Team Support: Act as CTA contact, coordinate meetings, support communications and logistics.
• Planning & Organization: Manage multiple priorities and timelines, support workload planning.
• Collaboration & Communication: Build relationships and communicate clearly with stakeholders.

Skills

Organizational skills

Attention to detail

Communication skills

Teamwork

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Are you highly organized, detail-oriented, and interested in contributing to clinical research? Do you have a first experience in clinical research ? Then this is a great opportunity for you ! We are looking for a Clinical Study Assistant to provide administrative and operational support to study teams throughout the lifecycle of clinical studies.

Presence at client's location (North of Brussels) is required.

Job Description

In this role, you will help ensure that study documentation is accurately maintained, regulatory and patient binders are prepared and distributed on time, and study-related materials are managed efficiently. Your work will directly contribute to compliance, quality assurance, and site audit readiness while supporting the successful execution of clinical studies.

Responsibilities

Study Document Management

Study Start-Up

• 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.

Document Control & Quality Assurance

• 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
  • Ethics Committee (EC) submission packages
  • Trial Master File (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 company SOPs.

Study Team Support

• Act as the primary CTA contact for assigned Business Units.
• Participate in study-related meetings and project discussions.
• Maintain investigational product records for regulated studies, where applicable.
• Support study communications, including newsletters and mailings.
• Track and coordinate the shipment of study-related equipment and data between sites, sponsors, and laboratories.
• Provide logistical support for meetings, including scheduling, agenda preparation, teleconference coordination, and meeting minutes.
• Assist with site activation and close-out activities.

Planning & Organization

• Manage multiple priorities simultaneously while meeting deadlines.
• Proactively identify potential risks to timelines and communicate them to management.
• Support effective workload planning to ensure project deliverables are achieved on time.

Collaboration & Communication

• Build effective working relationships.
• Communicate clearly and professionally with stakeholders at all levels.

Requirements

• 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
• Ability to handle multiple tasks and competing priorities in a dynamic environment.
• Strong communication and interpersonal skills.
• Ability to work both independently and as part of a collaborative team.
• Fluent in English; proficiency in an additional European language is considered an asset.
• Motivated to contribute to innovative clinical research that improves patient health.
• Existing right to work in Europe required

Benefits and contract information

• A balanced salary package based on your skills and experience
• Office-based position
• Permanent contract