English – Spanish speaking CRA with a minimum of 1-2 years experience – based in Belgium
Do you recognize yourself in below Skills & Competences:
- Clinical Trial Knowledge: Clear understanding of study designs, operational processes and regulations.
- 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.
- 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.
- Time Management & Prioritization: Skilled in managing multiple studies, meeting deadlines and adapt to shifting priorities and competing demands.
- Self-Motivated & Independent Worker: Effective in independently managing site activities, monitoring responsibilities and ensuring adherence to protocols and timelines.
In this role, you will have the opportunity to:
- 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
- Review and resolve data queries and discrepancies in collaboration with site staff and data management teams.
- Collaborate with site staff for proper reporting and follow-up of safety events, ensuring timely handling of safety issues.
- Identify and escalate protocol deviations, non-compliance issues and other risks to study integrity and subject safety as well as proactively address study-related issues and finds 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.
The essential requirements of the job include:
- Based in Belgium
- A Master of Science in a scientific, biological or medical science field
- Minimum of 1-2 years’ experience in clinical research or equivalent by education or relevant experience
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
- Proficient in Spanish and English – other languages are a plus
