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Clinical research associate

Halle (Anvers)
Junipr Research
Publiée le 18 février
Description de l'offre

Role Description
Junipr Research is looking for an experienced, tech-savvy Clinical Research Associate (CRA) to join our team in a dual-impact role. This position is designed for a clinical professional with some years of monitoring and/or clinical research experience who wants to move beyond traditional monitoring tasks. In this hybrid role, you will balance traditional CRA and patient engagement responsibilities, with a lead role in the implementation of digital solutions in our clinical operations. We are looking for someone who enjoys exploring new IT and AI-enabled systems to see how they can be practically applied to make clinical work more efficient, consistent, and compliant.
This role is ideal for a scientific problem-solver who enjoys structured work and meaningful interaction with sites and patients, but with a strong interest in digital tools, data, and patient-centric technologies.
We follow a hybrid model with an expected presence in the office or at study sites 2 to 3 days per week. A part-time schedule (60% – 80%) is a possibility if desired. Please note: this is a permanent payroll position and is not open to freelancers.

ResponsibilitiesClinical Operations Support
Study Coordination: Coordinate day-to-day trial activities from start-up through to close-out, ensuring all milestones and deliverables are tracked and met.
Site Oversight: Perform on-site and remote monitoring visits to ensure trial conduct aligns with the protocol, ISO 14155 / ICH-GCP principles, and regulatory requirements.
Documentation & Data: Review source documents and CRFs for accuracy; manage data queries, protocol deviations, and investigational product tracking.
Trial Master File: Maintain a compliant, audit-ready eTMF and assist with clinical trial management system maintenance.
Stakeholder Liaison: Manage professional communication with sites, sponsors, vendors, and ethics committees, including supporting contract and invoice workflows.
Clinical Digitalization & Innovation
Strategic Ownership: Lead Junipr's digital trajectory by identifying how automation and AI-enabled tools can be practically integrated into our clinical service lines.
System Development: Lead the implementation of digital workflows to improve project tracking, reporting dashboards, document generation, semi-automated translation workflow, and internal QMS tool. You will do this under coaching and in cooperation with our external expert.
Tech Exploration: Actively explore, test, and "tinker" with new AI-supported tools to find ways to improve the quality and efficiency of our clinical operations.
Hands-on Enablement: Act as the internal expert and "super-user," driving the adoption of new tools within the team and supporting digital onboarding for new colleagues.
Patient Engagement & Stakeholder Relations
Activity Coordination: Organize and facilitate patient advisory boards, surveys, prototype testing, and usability sessions.
Patient Interaction: Conduct structured interviews and pre-screening in an empathetic and professional manner, ensuring a high-quality experience for all participants.
Insights Management: Document and translate patient insights into clear, actionable reports for the sponsor.
Digital Governance: Ensure that the use of digital communication and social media tools within patient programs remains compliant with ethical, privacy, and regulatory requirements.
Quality Management & Operational Continuity
Continuous Improvement: Co-develop and maintain pragmatic clinical procedures and templates to ensure the team remains inspection-ready.
Compliance Point of Contact: Collaborate with our external DPO and QA to ensure our digital systems align with GDPR and evolving international frameworks (EU Medical Device Regulation & Clinical Trial Regulation, FDA guidelines)
Team & Office Operations: Manage daily office operations and team organization—from scheduling and internal documentation to technical onboarding and system access—while maintaining a warm, professional, and structured working environment.

Qualifications
Education: Bachelor's or Master's degree in a scientific, life sciences, or health-related field.
Clinical Experience: At least 1–2 years of hands-on experience in clinical research, specifically including monitoring activities (on-site ).
Regulatory Knowledge: Solid working knowledge of ICH-GCP principles and/or ISO Previous certification is required.
Languages: Excellent professional command of Dutch and English (both written and spoken). Knowledge of French or other languages is a significant plus.
Digital Mindset: Highly tech-savvy with a proactive interest in how AI and digital tools can optimize clinical workflows. You don't need a degree in IT, but you should enjoy "tinkering" with systems to find better ways of working. Having worked with Jira or Confluence (Atlassian platform) is a plus, but not a must.
Communication: Strong interpersonal skills with a friendly, professional style—essential for site management and patient engagement.
Organization: High attention to detail and the ability to manage multiple projects independently within a fast-paced team environment.
Mobility: Willingness to travel to study sites and client locations as required.

Why join Junipr Research?
Junipr Research is a growing company that works exclusively with talented people who value scientific excellence, quality, and initiative. Because we are a specialized team, this role offers a unique opportunity to move beyond traditional monitoring and take a lead role in shaping the future of digital clinical research.

At Junipr, you will:
Play a key role in supporting and developing both our clinical operations and our digital, AI-enabled service lines.
Gain broad exposure across diverse clinical studies, therapeutic areas, and innovative patient engagement activities.
Apply and master best practices in clinical operations, monitoring, and patient-centric research.
Grow quickly through hands-on learning and direct mentorship in an environment that encourages ownership and scientific curiosity.
Contribute to a positive and respectful experience for patients, sites, healthcare professionals, and sponsors.
Work in a supportive, collaborative team that values integrity, knowledge sharing, and professional growth.
Enjoy a hybrid work model that offers 1 to 2 days of remote work per week, balanced with the office collaboration and site visits essential to the role.
When desired, take advantage of the possibility for a part-time schedule (60% – 80%) to support your professional and personal balance.
Actively shape the way clinical trials are conducted by testing and implementing digital tools that improve efficiency and compliance.

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