Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.
Site and patient protection: ensures informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
Data quality oversight: performs source document verification, CRF review, and manages data queries to ensure accuracy and completeness.
Operational site management: prepares trip reports, ensures audit readiness, manages study files, coordinates with vendors, and uses resources efficiently.
Safety reporting: tracks and follows up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
Extended support activities: feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
Cross‑functional communication & logistics: liaises with internal teams, manages study materials, and travels as required.
By stepping into this role, you’ll join a highly collaborative, supportive, and growth‑oriented environment where your development is valued and your contributions truly make an impact