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Study Training Compliance:
- Track and monitor clinical staff training completion, including study-specific and mandatory compliance training.
- Support delegation processes during study start-up by verifying that training aligns with assigned roles.
- Ensure documentation of training is complete, current, and meets ICH-GCP, SOP, and sponsor requirements.
Delegation of Authority (DOA) Coordination:
- Support DOA matrix setup and maintenance by confirming training completion and role assignments.
- Work cross-functionally to ensure delegation readiness for protocol activities and study transitions.
eISF & Documentation Management:
- Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems.
- Ensure that site staff training records are audit-ready and aligned with regulatory and sponsor expectations.
- Support internal audits, monitoring visits, and sponsor document requests.
Care Access
Care Access aims to improve the future of health for everyone by bringing research and health services to communities. They operate with hundreds of research locations and mobile clinics across the globe and are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to medical breakthroughs.