Clinical Research Specialist

Clinitude; Vlaanderen; Sur place; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Clinitude is seeking an experienced Clinical Research Specialist to join our growing team in Belgium. You will support the planning, coordination and delivery of clinical studies, collaborating with clients, investigational sites and internal teams to ensure quality, timelines and regulatory compliance.

The role emphasizes taking ownership, proactive problem solving and gradual leadership as you develop project coordination responsibilities. Fluency in English is essential; Dutch is an asset.

Qualifications

• 3–5 years of clinical research experience, preferably including CRA work.
• Strong understanding of ICH-GCP and trial processes.
• Experience in monitoring, site management and study coordination.
• Excellent written and verbal English; Dutch is an asset.

Responsabilités

• Support the planning, coordination and operational management of clinical research projects.
• Coordinate study activities, timelines, deliverables and communication with clients, sites and external partners.
• Perform and oversee clinical monitoring activities when required, including site initiation, monitoring and close-out visits.
• Support and guide investigational sites to ensure compliance with protocols, GCP and applicable regulatory requirements.
• Review study documentation, monitoring reports and clinical data to identify risks, issues and opportunities for improvement.
• Contribute to project oversight, risk management, quality management and continuous process improvement.
• Support the development and review of study-specific plans, procedures and operational documentation.
• Gradually take on responsibility for coordinating small project teams and overseeing assigned activities.
• Act as a proactive point of contact for clients, providing practical advice and solutions to operational challenges.
• Collaborate across different clinical research functions and remain flexible in supporting evolving project and client needs.

Connaissances

Project coordination

Client communication

Team collaboration

English proficiency

Dutch asset

Formation

Bachelor's or master's in life sciences

Description du poste

At Clinitude, we are looking for an experienced and motivated Clinical Research Specialist to join our growing team.

As a clinical research business consulting company, we support our clients with practical expertise, strategic insights and hands-on operational solutions throughout the clinical study lifecycle.

This is a versatile role for someone with a solid background in clinical research, ideally including CRA experience, who is ready to broaden their responsibilities and gradually take on project coordination and leadership activities.

You will work closely with clients, investigational sites and internal teams, contributing to the successful delivery of clinical studies while helping identify opportunities to improve quality, efficiency and processes.

Success in this role means taking ownership, anticipating challenges, delivering high-quality work and contributing to practical solutions that make a difference for our clients.

Responsibilities

• Support the planning, coordination and operational management of clinical research projects.
• Coordinate study activities, timelines, deliverables and communication with clients, sites and external partners.
• Perform and oversee clinical monitoring activities when required, including site initiation, monitoring and close-out visits.
• Support and guide investigational sites to ensure compliance with protocols, GCP and applicable regulatory requirements.
• Review study documentation, monitoring reports and clinical data to identify risks, issues and opportunities for improvement.
• Contribute to project oversight, risk management, quality management and continuous process improvement.
• Support the development and review of study-specific plans, procedures and operational documentation.
• Gradually take on responsibility for coordinating small project teams and overseeing assigned activities.
• Act as a proactive point of contact for clients, providing practical advice and solutions to operational challenges.
• Collaborate across different clinical research functions and remain flexible in supporting evolving project and client needs.

Qualifications

• Bachelor's or master's degree in life sciences, healthcare or a related discipline.
• At least 3-5 years of relevant experience in clinical research, preferably including hands-on CRA experience.
• Good understanding of ICH-GCP, clinical trial processes and applicable regulatory requirements.
• Experience in clinical trial monitoring, site management and study coordination.
• Interest in developing project management and team coordination skills.
• Strong organisational, analytical and problem-solving abilities.
• Excellent written and verbal communication skills in English; Dutch is an asset.
• Ability to work independently, take ownership and manage multiple priorities.
• A proactive, pragmatic and client-focused mindset.
• Comfortable working in a smaller, dynamic organisation where flexibility, collaboration and initiative are valued.