Clinical Research Associate M/V/X

Description de la fonction

We are looking for a motivated, detail-oriented Clinical Research Associate (CRA) with strong scientific and analytical skills to join our team. This role goes beyond traditional monitoring and includes project support, patient engagement activities, study documentation, and collaboration with sites, patients, healthcare professionals, and sponsors.

You will ensure clinical trials are conducted with scientific integrity, operational excellence, and respect for all stakeholders. The role is mainly office-based at JunipR Research, with travel to study sites and occasional client support.

Responsibilities Monitoring & Study Oversight

• Conduct on-site and remote monitoring visits in line with study protocols, ISO 14155 / ICH-GCP, and applicable regulations.

• Review source data, CRFs, safety information, and protocol compliance.

• Ensure patient safety, including reporting adverse events and deviations.

• Verify investigational product handling, accountability, and storage.

• Train and support site staff on protocol and data requirements.

• Prepare monitoring visit reports and follow-up actions.

• Resolve data queries and discrepancies.

Patient Engagement Support

• Conduct or support patient interviews in a structured and empathetic way.

• Organize advisory boards, surveys, usability sessions, and prototype testing.

• Coordinate logistics, communication, and materials for patient activities.

• Document and report insights from patient engagement activities.

• Ensure a high-quality, respectful patient experience in all interactions.

Documentation & Quality

• Maintain study documentation and ensure TMF inspection readiness.

• Support preparation of study documents, reports, and meeting materials.

• Assist in investigator meetings and study-related documentation.

Project Management & Systems

• Collaborate with sites, project managers, and internal teams.

• Support study execution through project coordination tasks.

• Assist with CTMS/eTMF systems and SOP development.

Profil

Qualifications

• Master's degree or PhD in a scientific field preferred.

• Experience in clinical research through education or work.

• Knowledge of GCP (ISO 14155 / ICH-GCP) or strong willingness to learn.

• Good understanding of clinical trial processes and regulations.

• Strong computer skills (Microsoft Office).

• Excellent organizational, time management, and problem-solving skills.

• High attention to detail and accuracy.

• Strong communication skills and a professional, friendly approach.

• Able to work independently and in a team environment.

• Willingness to travel to study sites.

• Proactive, fast learner, and adaptable to new systems.

• Multilingual (English, Dutch, French) is an advantage.

Compétences linguistiques

• Anglais (atout)

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• Français (atout)

  • Comprendre : Aucune connaissance
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  • Parler : Aucune connaissance

• Néérlandais (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

Avantages du poste

Why Join JunipR Research?

JunipR is a growing company that works with highly talented people who value scientific excellence, quality, respect, and initiative. We offer a unique opportunity to contribute to impactful clinical work while developing broad expertise across clinical operations, patient engagement, monitoring, systems, and documentation.

At JunipR, you will:

• Play a key role in the development and delivery of our clinical services.

• Gain experience across diverse clinical studies and therapeutic areas.

• Learn and apply best practices in clinical trial monitoring and project management.

• Benefit from strong career growth in a varied and dynamic role.

• Contribute to a positive experience for sites, patients, HCPs, and sponsors.

• Work in a supportive, collaborative team that values knowledge sharing.

• Benefit from a flexible Work From Home policy.

• Grow in an environment that values integrity, curiosity, ownership, and continuous learning.

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