Senior Clinical Research Associate, 0.5 FTE
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Job Description
Senior Clinical Research Associate supporting Parexel’s oncology clinical trials in Belgium. Ensuring site compliance, patient safety, data integrity, and inspection readiness through remote and on-site monitoring.
Responsibilities:
- Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites
- Evaluate site performance, recommend site-specific actions, escalate significant issues, and support corrective action plans
- Verify informed consent processes are appropriately conducted and documented
- Assess patient safety and clinical data integrity, including protocol deviations, violations, pharmacovigilance concerns, and site-level risks
- Conduct remote and on-site monitoring according to the Clinical Monitoring Plan and Study Monitoring Plan
- Perform source document review and verification of clinical data entered into case report forms
- Manage protocol deviation reporting, follow-up activities, and resolution of data queries
- Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and documentation
- Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and required study documentation
- Ensure appropriately trained and delegated site personnel perform study activities
- Maintain tracking of observations, action items, site status, and study progress in required systems
- Review essential study records to maintain inspection readiness
- Participate in investigator, sponsor, monitoring, and project team meetings
- Collaborate with the primary Site Manager and stakeholders to support study objectives, deliverables, and timelines
Requirements:
- Bachelor's degree, Registered Nurse (RN), or an equivalent combination of education, training, and experience
- Experience in clinical research monitoring with oncology trial experience and knowledge of RECIST criteria
- Knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial processes
- Experience conducting on-site and remote monitoring activities
- Strong verbal and written communication, presentation, organizational, and interpersonal skills
- Ability to build and maintain effective relationships with investigator site personnel and study stakeholders
- Proficiency in the local language
- Advanced-level or fluent English language skills
- Experience working within sponsor-dedicated clinical research environments preferred
Benefits:
- Part-time 0.5 FTE schedule
- Remote/home-based capacity
- Continuous learning and professional development
- Flexible work environment
- Growth opportunities
- Meaningful impact on clinical research and patient care
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