Medical Devices: Clinical Research Associate (CRA)

AMARIS GROUP SA; Eindhoven; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Multiple medical device projects

Exposure to Class I–III devices

Consulting environment

Training and development

International, multidisciplinary team

Competitive salary and benefits

Job summary

Amaris Consulting is seeking an experienced Clinical Research Associate to support multiple medical device projects across sponsor‑dedicated trials. You will monitor sites, ensure GCP/ISO 14155 compliance and manage TMF/ISF documentation in a consulting setting.

The role requires traveling to clinical sites, strong communication skills, and English proficiency; Dutch is a plus. You will join an international team delivering clinical research excellence.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medicine or related discipline.
• Proven professional experience as a Clinical Research Associate within the Medical Device industry is required.
• Experience with clinical investigations involving Class I, Class II and/or Class III medical devices.
• Strong knowledge of ISO 14155 and Good Clinical Practice (GCP).
• Understanding of the EU Medical Device Regulation (MDR) and the clinical evaluation framework.
• Experience with TMF/ISF documentation and monitoring activities.
• Strong understanding of clinical study processes from study start‑up through close‑out.
• Excellent communication and stakeholder‑management skills.
• Ability to work independently while collaborating with international project teams.
• Willingness to travel to clinical sites.
• Professional proficiency in English; Dutch is a plus.

Responsibilities

• Support the planning, execution and follow‑up of clinical investigations for medical devices.
• Perform site selection, initiation, monitoring and close‑out activities in accordance with study requirements.
• Conduct routine monitoring visits and ensure appropriate follow‑up of clinical sites.
• Ensure clinical studies are conducted in compliance with Good Clinical Practice (GCP) and ISO 14155.
• Support study start‑up activities, including site qualification, regulatory documentation and essential documents.
• Review and maintain TMF/ISF documentation.
• Monitor clinical data and documentation for completeness, accuracy and compliance.
• Identify, document and follow up on protocol deviations and other study issues.
• Collaborate with investigators, study coordinators, sponsors, medical experts and cross‑functional project teams.
• Support management and reporting of safety events and device‑related incidents.
• Contribute to clinical study reports and monitoring reports.
• Support audits and inspections where required.
• Provide regular study status updates and elevate risks or issues.

Skills

Communication

Stakeholder management

English proficiency

Education

Life Sciences related degree

Job description

Amaris Consulting is seeking an experienced Clinical Research Associate to support multiple medical device projects across sponsor‑dedicated trials. You will monitor sites, ensure GCP/ISO 14155 compliance and manage TMF/ISF documentation in a consulting setting.

The role requires traveling to clinical sites, strong communication skills, and English proficiency; Dutch is a plus. You will join an international team delivering clinical research excellence.