Amaris Consulting is seeking a proactive and detail-oriented Senior Clinical Research Coordinator (CRC) to join our Life Sciences team. In this role, you will provide advanced support to Clinical Research Associates (CRAs) and project teams in the set-up, coordination, and ongoing maintenance of clinical trials across medical devices, pharmaceuticals, and biotechnology. You will play a key part in ensuring studies are conducted in compliance with GCP, GDP, and applicable regulatory requirements, while maintaining high-quality documentation and supporting site operations.
This position offers strong opportunities for professional growth, with potential to develop into a CRA role.
Support CRAs with monitoring activities, including co-monitoring visits when required.
Take ownership of study set-up activities, including:
Ensuring all required documents and approvals are in place.
Managing investigator and site access to study systems.
Tracking and obtaining all required signatures.
Maintain study systems and databases, including MediData Rave and other electronic platforms, ensuring accurate filing of study documents.
Perform data entry, validation, and quality checks across electronic trial systems.
Support preparation and submission of study-related documents (e.g., IRB/EC submissions, amendments, renewals).
Coordinate and track essential study activities such as site training, initiation, and ongoing compliance.
Manage study logistics including study equipment, labeling, shipments, and returns.
Ensure compliance with Good Clinical Practice (GCP), Good Documentation Practice (GDP), and internal SOPs.
Act as a point of contact for sites, vendors, and internal stakeholders, ensuring effective communication and follow-up.
Assist in the development of study reports, metrics, and regulatory documentation.
Bachelor’s or Master’s degree in Life Sciences, Nursing, or related field.
5+ years’ experience as a Clinical Research Coordinator or in a similar role within medical devices, pharma, or biotech.
Strong working knowledge of GCP, GDP, and ICH guidelines.
Proven experience with clinical study systems, ideally including MediData Rave.
Comfortable working with electronic tools and databases; advanced MS Office (Excel, Word, PowerPoint).
Ability to work autonomously and proactively, while also collaborating effectively in a team.
Excellent organizational skills, with strong attention to detail and ability to manage multiple priorities.
Strong communication skills, fluent in Dutch and English (written and spoken).
Willingness to grow into a CRA role over time.
Opportunity to be part of a global consulting leader in Life Sciences.
A dynamic, international work environment with room for personal and professional growth.
Career progression opportunities towards Clinical Research Associate roles.
Competitive salary and benefits package.