House Clinical Research Associate

Kelly Science, Engineering, Technology & Telecom; Belgique; Sur place; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

International clinical research exp.

Professional development

Résumé du poste

We are recruiting for a Site In-House Clinical Research Associate II - EMEA based in Brussels, Belgium. The role supports planning, initiation, execution and closeout of clinical studies across the EMEA region and collaborates with global teams to ensure protocols, regulatory requirements and GCP are followed.

The successful candidate will act as a key contact for assigned sites, assist with activation, regulatory documentation, data quality and issue resolution, and travel up to 50% as required.

Qualifications

• Bachelor’s degree from an accredited university or college, preferably in Natural Sciences, Pre-Medicine, Nursing, Bioengineering or related discipline.
• Minimum 5 years of relevant clinical research experience.
• Experience within the medical device industry is highly desirable.
• Good understanding of GCP and regulatory requirements.
• Experience working with clinical research sites and investigators.

Responsabilités

• Coordinate startup, maintenance and closeout of study sites in partnership with clinical personnel.
• Serve as primary contact for assigned study sites and manage site relationships.
• Review regulatory and study documentation for accuracy and compliance.
• Support site activation activities and data/query resolution.
• Mentor junior team members and contribute to process improvements.

Connaissances

Clinical Research

GCP Compliance

Site Management

Communication

Stakeholder Mgmt

Organization

Problem Solving

Attention to Detail

Independence

Mentoring

Formation

Bachelor's degree (Natural sciences)

Outils

Microsoft Office

eClinical Systems

Description du poste

Site In-House Clinical Research Associate II - EMEA

Location: Brussels, Belgium

Employment Type: Full-Time, 12-Month Fixed-Term Contract

Hours: 40 hours per week

Working Model: Site-based / In-house

Start Date: To be confirmed

Project Status: Pipeline opportunity, pending final client approval

Client: Leading Global Medical Device Organisation

About the Role:

We are currently building a pipeline for an exciting opportunity with a leading global medical device organisation for a Site In-House Clinical Research Associate II - EMEA, based in Brussels.

The Site In-House Clinical Research Associate II will support the planning, initiation, execution and closeout of clinical studies at assigned study sites. Working closely with the wider Clinical Research and Site Management teams, this role will help ensure studies are conducted in accordance with approved protocols, applicable regulations, Good Clinical Practice (GCP) and established company procedures.

The successful candidate will act as a key point of contact for assigned clinical sites, supporting site activation, ongoing study activities, regulatory documentation, data quality and issue resolution. The role will also involve collaboration with field-based clinical personnel, internal study teams and site staff across the clinical trial lifecycle.

This is an excellent opportunity for an experienced clinical research professional looking to work within a global medical device environment and contribute to the delivery of innovative clinical studies.

Key Responsibilities

• Support regulatory and clinical protocol compliance across assigned clinical studies and study sites.
• Coordinate the startup, maintenance and closeout of assigned clinical study sites in partnership with field-based and in-house clinical personnel.
• Act as the primary point of contact for assigned study sites and maintain effective relationships with site investigators and research teams.
• Support site activation activities, including collection, review and maintenance of required regulatory and study documentation.
• Review informed consent documents to ensure all required elements are present and appropriately documented.
• Review and analyse clinical study data and regulatory documentation for accuracy, completeness and compliance.
• Support the identification, tracking and resolution of data queries and documentation discrepancies.
• Follow up on findings identified during monitoring visits, audits and other quality activities, supporting timely resolution and appropriate documentation.
• Serve as a liaison between Clinical Study Management, Site Management and site personnel regarding protocol-related questions and issues.
• Escalate significant study, site, compliance or quality issues to the appropriate internal stakeholders.
• Support the implementation of clinical research processes and contribute to continuous improvement initiatives.
• Assist with training internal and external clinical professionals on study protocols, clinical processes and applicable procedures.
• Maintain accurate and up-to-date clinical trial information within internal systems and document management platforms.
• Collect, maintain and communicate regional and site-specific information required to support study activation and execution.
• Monitor site progress against study timelines and support the identification of potential delays or risks.
• Maintain effective communication with study teams and sites throughout the clinical trial lifecycle.
• Mentor and provide guidance to less experienced clinical team members where required.
• Act as a study champion for assigned projects where appropriate.
• Contribute to global and regional clinical research process improvement initiatives.

Required Qualifications & Experience

• Bachelor’s degree from an accredited university or college, preferably in Natural Sciences, Pre-Medicine, Nursing, Bioengineering or a related discipline.
• Minimum 5 years of relevant clinical research experience, or an equivalent combination of education and professional experience.
• Experience within the medical device industry is highly desirable.
• Strong understanding of clinical trial processes, including study startup, site activation, study execution and closeout.
• Good understanding of clinical research regulations, Good Clinical Practice (GCP) and clinical protocol requirements.
• Experience working directly with clinical research sites, investigators and research staff.
• Ability to review clinical and regulatory documentation for accuracy, completeness and compliance.
• Strong written and verbal communication skills.
• Excellent interpersonal and stakeholder management skills.
• Strong analytical and organisational capabilities with excellent attention to detail.
• Ability to interpret basic clinical data and identify potential issues or inconsistencies.
• Ability to manage multiple priorities and meet study timelines and deadlines.
• Proficiency in Microsoft Office Suite and relevant clinical research applications and systems.
• Ability to work independently with limited supervision.
• Willingness and ability to travel as required, with up to approximately 50% travel potentially required.

Preferred Qualifications

• Strong familiarity with clinical trial research processes and clinical study management.
• Previous clinical research experience within a medical device, pharmaceutical, biotechnology or healthcare organisation.
• Experience supporting clinical studies across multiple countries or regions.
• Experience working with clinical trial documentation and electronic document management systems.Experience supporting regulatory submissions or site regulatory requirements.
• Previous experience supporting monitoring findings, audits or quality investigations.
• Certification as a Research Professional through SoCRA or ACRP.
• Experience mentoring or supporting the development of junior clinical research professionals.
• Experience contributing to clinical research process improvement initiatives.

Skills & Competencies

The successful candidate will demonstrate:

• Clinical Research Expertise: Strong practical understanding of clinical trial execution and site management processes.
• Protocol & GCP Compliance: Ability to ensure clinical activities and documentation remain aligned with approved protocols, GCP and applicable requirements.
• Site Management: Confidence acting as a primary contact for clinical research sites and maintaining productive investigator relationships.
• Communication: Excellent written and verbal communication skills with the ability to communicate effectively with clinical professionals at all levels.
• Stakeholder Management: Ability to work collaboratively across Clinical Operations, Site Management, Clinical Study Management and external research sites.
• Organisation: Strong ability to manage multiple sites, activities, priorities and deadlines simultaneously.
• Problem Solving: Ability to identify issues, support resolution and ESCALATE appropriately.
• Attention to Detail: High level of accuracy when reviewing clinical data, regulatory documents and study records.
• Independence: Comfortable taking ownership of assigned activities while working with limited supervision.
• Mentoring: Ability to provide guidance and support to less experienced clinical team members.

What We Offer

• Full-time, 40-hour working week.
• 12-month fixed-term contract.
• Opportunity to work within a leading global medical device organisation.
• Exposure to international clinical research activities across the EMEA region.
• Collaboration with experienced clinical research, site management and study management professionals.
• Opportunity to contribute to the delivery of clinical studies involving innovative medical technologies.
• Professional development through exposure to complex clinical research programmes and cross-functional teams.

Location & Travel:

This position is based in Brussels, Belgium, and will involve close interaction with assigned clinical study sites and internal clinical teams.

Travel of up to approximately 50% may be required, depending on study requirements and assigned site activities.

Important Information:

This position is currently being developed as part of a client project pipeline and is subject to final client approval. Further information regarding the confirmed start date, study assignment and project scope will be provided once client approval has been received.

Candidates must be based in Belgium and have the right to work in Belgium.