Clinical Research Associate – Single Sponsor

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits, either on-site or remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess site and staff performance, providing actionable recommendations and plans for improvement.

• Verify informed consent processes, ensuring subject confidentiality, safety, and integrity of clinical data.

• Evaluate site processes in accordance with the Clinical Monitoring/Site Management Plan.

• Perform source document reviews and confirm the accuracy and completeness of case report form data.

• Address queries both remotely and on-site within established timelines.

• Utilize hardware and software for the review and capture of clinical study data.

• Ensure compliance with electronic data capture standards.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, and administration as necessary.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document monitoring activities through letters, trip reports, communication logs, and project documentation.

• Assist with subject recruitment, retention, and awareness initiatives.

• Monitor observations, site status, and track action items to resolution.

• Manage site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Collaborate with study site personnel, ensuring that assigned sites and project team members receive appropriate training and maintain compliance.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Facilitate audit readiness and follow-up actions post-audit.

• Complete assigned training and stay informed about relevant guidelines, regulations, and SOPs.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Prior monitoring experience in Belgium is essential.

• Proficient computer skills with an openness to adopting new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Capability to manage necessary travel for monitoring visits.

• Proficient in Dutch, French, and English.

• Working knowledge of relevant regulations and company SOPs/processes.

• Experience in conducting clinical monitoring activities, including site qualification, initiation, interim monitoring, site management, and close-out visits.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate.