IntraCare

• Provide operational leadership and quality oversight across clinical research sites. • Train, onboard, and mentor Clinical Research Coordinators and research staff. • Develop and maintain standardized workflows, SOPs, and best practices across sites. • Review source documentation, regulatory files, and study data for completeness, accuracy, and protocol compliance before submission. • Ensure compliance with study protocols, ICH-GCP guidelines, sponsor requirements, and internal SOPs. • Support regulatory document preparation and maintenance of essential study files. • Assist sites with audit readiness, monitoring visit preparation, and corrective action implementation. • Provide ongoing education and retraining to research staff as protocols and processes evolve. • Monitor research quality metrics and identify opportunities for operational improvement. • Collaborate with investigators, site leadership, sponsors, and operations to maintain high-quality research standards.