Senior Clinical Research Associate

Minimum prerequisites

• 2+ years of hands-on medical devices experience as CRA
• Based in Belgium

• Clinical Trial Knowledge: in-depth understanding of study designs, operational processes, and regulations.
• Time Management & Prioritization: skilled in managing multiple studies, meeting deadlines and adapting to shifting priorities and competing demands.
• Communication
  
  Skills:
  
  clear, professional, and collaborative interaction with cross‑functional teams, investigators, and sponsors.
• Problem‑Solving & Decision‑Making: proficient in identifying issues and making data‑driven decisions.
• Leadership & Mentoring: experience in guiding junior CRAs and leading site and project activities.
• Relationship Building & Teamwork: strong at building partnerships with stakeholders and fostering collaboration across diverse teams.
• Adaptability & Attention to Detail: flexible in dynamic environments while ensuring compliance.
• Self‑Motivated & Independent Worker: effective in independently managing site activities, monitoring responsibilities, and ensuring adherence to protocols and timelines.

• Act as responsible person managing clinical study sites across various phases of the clinical study.
• Conduct qualification visits, site initiation visits, interim monitoring visits and close‑out visits to ensure adherence to study protocols, monitoring plans and applicable other study plans and manuals, applicable standard operating procedures, and relevant regulations.
• Communicate regularly with investigators and site staff to provide guidance, support, and training about study‑related matters to ensure compliance.
• Identify and escalate protocol deviations, non‑compliance issues, and other risks to study integrity and subject safety and proactively address study‑related issues and find the appropriate solutions independently or in cooperation with project lead or project manager.
• Manage study supplies and oversee device accountability at sites.
• Facilitate communication and collaboration between study sites and other stakeholders, such as sponsor team, CROs, vendors and ethics committees.
• Interact with vendors as necessary.
• Actively participate in study team meetings.

• A Master of Science in a scientific, biological, or medical science field.
• Minimum of 2 years’ experience in clinical research or equivalent by education or relevant experience.
• Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook).
• Multilingual proficiency can be advantageous for international trials.