Senior Clinical Research Associate, 0.5 FTE

• 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

• 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

• 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