Senior Clinical Research Associate, 0.5 FTE

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Ensure adherence to study protocols, ICH-GCP guidelines, regulatory standards, and company procedures across designated sites.

• Assess site performance, suggest site-specific measures, escalate critical issues, and assist in implementing corrective action plans.

• Confirm that informed consent processes are properly executed and documented.

• Evaluate patient safety and the integrity of clinical data, including protocol deviations, violations, pharmacovigilance issues, and site-level risks.

• Perform both remote and on-site monitoring in accordance with the Clinical Monitoring Plan and Study Monitoring Plan.

• Conduct reviews of source documents and verify the accuracy of clinical data entered into case report forms.

• Oversee protocol deviation reporting, follow-up actions, and the resolution of data queries.

• Examine investigational product accountability, including storage, security, dispensing, administration, reconciliation, and documentation.

• Record monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and necessary study documentation.

• Ensure that adequately trained and designated site personnel carry out study activities.

• Maintain a record of observations, action items, site status, and study progress in the required systems.

• Review essential study documentation to ensure readiness for inspections.

• Participate in meetings with investigators, sponsors, monitors, and the project team.

• Collaborate with the primary Site Manager and relevant stakeholders to achieve study objectives, deliverables, and timelines.

⛳️ Requirements

• Bachelor's degree, Registered Nurse (RN), or a comparable combination of education, training, and experience.

• Experience in clinical research monitoring, particularly with oncology trials, and familiarity with RECIST criteria.

• Knowledge of ICH-GCP, relevant regulatory requirements, and the clinical trial process.

• Experience in conducting both on-site and remote monitoring activities.

• Strong verbal and written communication, presentation, organizational, and interpersonal abilities.

• Capability to establish and maintain effective relationships with investigator site personnel and study stakeholders.

• Proficiency in the local language.

• Advanced or fluent English language skills.

• Preference for experience in sponsor-dedicated clinical research environments.

🏝️ Benefits

• Part-time 0.5 FTE schedule.

• Remote/home-based work capability.

• Opportunities for continuous learning and professional development.

• Flexible work environment.

• Opportunities for growth.

• A meaningful impact on clinical research and patient care.