For one of our clients, a global Medical Device company we are looking for an In House-CRA, to support the Global Clinical Operations (GCO) Center of Excellence, driving technology enablement, process innovation, and clinical excellence across divisions.

Job Description

As a In House Clinical Research Associate (CRA) within our Global Clinical Operations (GCO) organization, you will play a critical role in enabling the timely and compliant initiation of our clinical studies in the medical device field.

You will support the GCO Center of Excellence (CoE), conducting activities aligned with its mission to build a world-class shared clinical technology and operations capability. This includes process innovation, technology enablement, high-touch customer service, and study acceleration - all delivered with a strong focus on quality and compliance.

A chance to contribute to the launch of innovative medical technologies that improve patient outcomes globally.
A collaborative, mission-driven culture that values teamwork, integrity, and continuous learning.
Global exposure, cross-functional collaboration, and development opportunities within a leading MedTech organization.
A flexible hybrid work environment designed to balance focus, engagement and team connection.

Responsibilities

Coordinate and Lead: Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, drive site, (EC) Ethics Committee regulatory submissions and essential document collection for clinical research sites throughout start up, enrollment, follow-up, and closure of clinical trial activities.
Document Management: Handle multiple sets of essential regulatory documents across several studies, with opportunity of exposure to multidivisional clinical trials.
Collaborate: Partner with clinical sites to negotiate and customize Informed Consent Forms (ICF). Collaborate cross functionally to achieve business objectives.
Relationship Building: Develop and foster relationships with internal customers and clinical research sites to become subject matter experts in site start-up regulatory processes.
Problem Solving: Assist clinical research sites with application submission processes and approval tracking to meet target Institutional Review Board (IRB) / EC timelines. Problem-solve site start-up challenges to mitigate impact on service level agreements and study goals.
Prepare and Track: Prepare, complete, and track required regulatory, Informed Consent Forms (ICFs), and legal documentation.
Quality Assurance: Document site and investigator readiness for participation across multiple studies.
Support: Assist with internal quality audits and regulatory inspections.
Maintenance: Keep study-specific startup and close-out trackers updated.
Update: Maintain site-specific metrics in Clinical Trial Management Systems and electronic Trial Master File (eTMF).
Communication: Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, and approval status.
Compliance: Ensure adherence to regulatory requirements (ICH/GCP, MDR, GDPR) and internal Standard Operating Procedures (SOPs) Working Instructions (WIs), policies, and procedures.

Requirements

Educational Background: Degree in a relevant scientific or healthcare discipline.
min 3-5 years of experience in clinical trials' submissions to Ethics Committees.
Fluency in French, English and Dutch, additional languages are an advantage.
Strong communication and interpersonal skills to collaborate effectively with clinical research site personnel.
Proven ability to work both independently and as part of a cross-functional team.
Demonstrated problem-solving skills, adaptability, and learning agility.

Preferred Qualifications

Previous experience as a Research Coordinator or In House Clinical Research Associate/Study Start-up Specialist.
Familiarity with clinical trial management systems (Veeva) and clinical document control systems (eTMF).
Familiarity with Good Clinical Practice (GCP), ICH guidelines
Experience with the local regulatory/ethics requirements
Ability and willingness to work from the office approximately two days per week to engage with the team, exchange knowledge, and strengthen collaboration.
Existing rights to work in Europe and Belgium

Contract Information

Full-time position
Permanent contract as a consultant
Hybrid Work Model in Brussels - (approximately two days per week in the office) to foster collaboration, strengthen team spirit, and leverage the benefits of in-person connection and learning.

Vacancy number : 26808

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